[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-failure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-failure":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,688,0,25,[9,44,65,84,108,157,182,205,255,282,301,329,352,373,393,416,436,469,493,523,542,568,592,611,630],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100635042","a-study-of-ly3971297-in-participants-with-heart-failure-100635042",false,"NCT07547540","A Study of LY3971297 in Participants With Heart Failure","A Phase 1, Single-Blinded, Single-Ascending Dose Study to Evaluate the Safety and Tolerability of a Single Dose of LY3971297 in Participants With HFpEF and Participants With HFrEF","Inclusion Criteria:\n\n* Are diagnosed with chronic heart failure with New York Heart Association Class II-III (Heart Failure) HF symptomatology at screening and on guideline-directed HF therapy for at least 6 months prior to screening.\n* Have not changed optimal guideline-directed HF therapy, either medication or medication dose, in the last 4 weeks prior to screening and during screening period, and do not plan to change HF therapy for the next 90 days.\n* Must be on a stable dose of vasodilator therapy for at least 4 weeks prior to screening, with no dose adjustments planned during the study.\n* Have an estimated glomerular filtration rate of greater than or equal to (≥) 30 milliliter per minute per 1.73 square meters (mL\u002FMinute\u002F1.73m²) at screening.\n* Have systolic blood pressure (SBP) greater than (\\>) 110 millimeters of mercury (mmHg) at screening and at enrollment.\n* Have a body mass index within the range of 18.5 to 40 kilograms per square meter (kg\u002Fm²) (inclusive).\n* Are individuals assigned male or female at birth, who are not of childbearing potential.\n* Have venous access sufficient to allow blood sampling.\n* Applicable to heart failure with preserved ejection fraction (HFpEF) participants only\n\n  * Have left ventricular ejection fraction (LVEF) \\>45 percent (%).\n  * Left atrial volume index \\>34 milliliters per square meter (mL\u002Fm²) in participants in sinus rhythm, or \\>40 mL\u002Fm² in participants with atrial fibrillation (AF).\n  * N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\>300 picograms per milliliter (pg\u002FmL) for participants without AF or \\>850 pg\u002FmL for participants with AF.\n  * Have a documented history of signs, symptoms, or both, consistent with HFpEF.\n* Applicable to heart failure with reduced ejection fraction (HFrEF) participants only:\n\n  * Have LVEF \\\u003C40% .\n  * NT-proBNP \\>600 pg\u002FmL for participants without AF or \\>900 pg\u002FmL for participants with AF.\n  * Have a documented history of signs, symptoms, or both, consistent with HFrEF.\n\nExclusion Criteria:\n\n* Have known allergies to related compounds of LY3971297 or any components of the formulation, or a history of significant atopy.\n* Had a myocardial infarction, unstable angina pectoris, coronary artery bypass graft surgery, revascularization or other major cardiovascular surgery, stroke, or transient ischemic attack in the last 90 days prior to screening.\n* Have New York Heart Association (NYHA) Class 4, acute decompensated HF (exacerbation of HF) requiring IV diuretics, IV inotropes, or IV vasodilators, within 30 days prior to screening, and\u002For during screening period until randomization.\n* Have SBP ≥180 mmHg at screening.\n* Have symptomatic hypotension.\n* Have resting heart rate \\>90 beats per minute (bpm) at screening.\n* Have known cardiac amyloidosis, infiltrative myocardial diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic cardiomyopathy, pericardial constriction, or complex congenital heart disease.\n* Have any history of moderate-to-severe stenosis of the mitral and\u002For aortic valve or severe mitral and\u002For aortic regurgitation.\n* Have any history of moderate-to-severe tricuspid or pulmonic valve stenosis or severe tricuspid or pulmonic regurgitation.\n* Have a history of syncope that, in the opinion of the investigator, may affect the participant's safety.\n* Bioprosthetic valve replacement within 12 months prior to screening or any history of mechanical valve replacement, or planned valve replacement or repair during the study period.\n* Have any history of greater than moderate pulmonary hypertension.\n* Have a pacemaker or implantable cardioverter-defibrillator placement within 90 days prior to screening.\n* Have severe chronic obstructive pulmonary disease (COPD).\n* Have clinically significant or uncontrolled cardiac arrhythmia.\n* Have a significant history of, or presence of, hepatic disease, including any abnormal liver function tests.\n* Have, within 3 years prior to screening, a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (Exceptions: basal or squamous cell skin cancer).\n* For US sites: have donated blood of more than 500 mL within the previous 90 days of screening or intend to donate blood during the course of the study.\n* For Japan sites: have donated any blood within the last 4 weeks, any apheresis (blood components) within the last 2 weeks, at least 400 mL of blood within the last 16 weeks for female participants or 12 weeks for male participants, or at least 800 mL of blood for female participants or 1200 mL of blood for male participants within 12 months.\n* Other sites: Participants who have recently donated blood or blood components, or who intend to donate during the course of the study.\n* Have not been on a stable dose of medications for at least 4 weeks prior to screening, or have planned dose adjustments during the study.\n* Participants must abstain from taking new prescription or nonprescription drugs.\n* Have concurrent use or intend to use phosphodiesterase 5 inhibitor or soluble guanylyl cyclase activators.\n* Have any history of intolerance to vasodilator medications that, in the opinion of the investigator, would put them at risk of not tolerating study drug.\n* Have BP and\u002For pulse rate constituting a risk when taking the Investigational Medicinal Product (IMP).\n* Are diagnosed with orthostatic hypotension.\n* Show evidence of an acute infection with fever or infectious disease at screening.\n* Applicable to HFrEF participants only\n\n  * Have been listed for cardiac transplantation and\u002For anticipated or implanted ventricular assist device.\n  * Have received cardiac resynchronization therapy for less than 6 months.\n* Hospitalization for heart failure within 30 days of screening.","ALL","18 Years","65 Years",{"count":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The main purpose of this study is to assess how well LY3971297 is tolerated and what side effects may occur in participants with heart failure with preserved ejection fraction (HFpEF) and participants with heart failure with reduced ejection fraction (HFrEF). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last about 2 months and will include 1 inpatient visit lasting approximately 4 days and 5 outpatient visits.",[28,29,30],"Heart Failure","Heart Failure, Diastolic","Heart Failure, Systolic","RECRUITING","2026-08-20",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":35},"2026-08-11",{"date":39,"type":22},"2027-11",{"name":41,"class":42},"Eli Lilly and Company","INDUSTRY",12,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100587975","phase-3-a-study-to-test-whether-vicadrostat-bi-690517-in-combination-with-empagliflozin-helps-people-with-heart-failure-and-a-weak-pumping-function-of-the-left-side-of-the-heart-100587975","NCT06935370","A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart","EASi-HF Reduced - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Chronic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) \u003C 40%","Inclusion criteria:\n\n1. At least 18 years old and at least at the legal age of consent in countries where it is greater than 18 years\n2. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial\n3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the protocol.\n4. Chronic heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) classes II to IV at Visit 1, with left ventricular ejection fraction (LVEF) \\\u003C 40% per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computed tomography (CT)).\n5. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory\n6. Treated according to best possible standard of care (SOC) (disregarding sodium-dependent glucose co-transporter 2 inhibitor (SGLT2i) and mineralocorticoid receptor antagonist (MRA)) in accordance with applicable heart failure (HF) local\u002Finternational guidelines and judgement of the investigator.\n\nAdditional inclusion criteria apply.\n\nExclusion criteria:\n\n1. Treatment with an MRA (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with an MRA should not be discontinued with the intention of study enrolment.\n2. Treatment with amiloride or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator.\n3. Receiving the following treatments:\n\n   * A direct renin inhibitor (e.g. aliskiren) at Visit 2\n   * More than one angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNi) used simultaneously at Visit 2\n   * Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial\n   * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2\n   * In case of acute decompensated HF:\n\n     * i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation\n     * i.v. diuretic with a dose that has been increased\u002Fintensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)\n4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft surgery (CABG), heart valve surgery\u002Fintervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, CABG)\n5. Percutaneous coronary intervention (PCI) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2\n6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)\n7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within 12 months prior to Visit 1 and until Visit 2\n8. Acute inflammatory heart disease, such as acute myocarditis, within 90 days preceding prior to Visit 1 and until Visit 2 Further exclusion criteria apply.",{"count":52,"type":22},4200,[54],"PHASE3","This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure.\n\nIn this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat\u002Fempagliflozin tablets, and the other group takes placebo\u002Fempagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between about 6 months and about 3.5 years. During this time, they can continue their regular treatment for heart failure.\n\nParticipants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone for some visits. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, go to hospital due to heart failure or die during the study. The time until these events are observed is compared between the two treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[28],{"date":34,"type":35},{"date":59,"type":35},"2025-05-20",{"date":61,"type":22},"2029-02-22",{"name":63,"class":42},"Boehringer Ingelheim",589,{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100548691","phase-3-a-study-to-test-whether-vicadrostat-in-combination-with-empagliflozin-helps-people-with-heart-failure-100548691","NCT06424288","A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure","EASi-HF Preserved - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) ≥40%","Inclusion criteria:\n\n1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years\n2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information\n4. Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2\n5. Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2\n6. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:\n\n   1. in participants with body mass index (BMI) \\\u003C27 kg\u002Fm²: ≥300 pg\u002FmL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg\u002FmL for participants with Afib or Aflutter (at Visit 1 ECG)\n   2. in participants with BMI ≥27 kg\u002Fm² to \\\u003C35 kg\u002Fm²: ≥220 pg\u002FmL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg\u002FmL for participants with Afib or Aflutter (at Visit 1 ECG)\n   3. in participants with BMI ≥35 kg\u002Fm²: ≥125 pg\u002FmL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg\u002FmL for participants with Afib or Aflutter (at Visit 1 ECG)\n7. At least one of the following:\n\n   * Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1\n   * Documented hospitalisation for HF within 6 months prior to Visit 1\n   * Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1\n\n     * in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg\u002FmL\n     * for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg\u002FmL\n   * Urine albumin-to-creatinine ratio (UACR) ≥30 mg\u002Fg, analysed at the central laboratory at Visit 1\n8. Treated according to best possible standard of care (SOC) (disregarding Sodium-dependent glucose co-transporter 2 inhibitors (SGLT2is) and Mineralocorticoid receptor antagonists (MRAs)) in accordance with applicable HF local\u002Finternational guidelines and judgment of the investigator Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Treatment with an mineralocorticoid receptor antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with MRA should not be interrupted with the intention of enrolment into the study\n2. Treatment with amiloride, or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator\n3. Receiving the following treatments:\n\n   * a direct renin inhibitor (e.g. aliskiren) at Visit 2\n   * more than one angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) used simultaneously at Visit 2\n   * In case of acute decompensated HF:\n\n     * i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation (Visit 2)\n     * i.v. diuretic with a dose that has been increased\u002Fintensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)\n   * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2\n   * Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial\n4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, heart valve surgery\u002Fintervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, coronary artery bypass graft surgery\u002FCABG)\n5. Percutaneous coronary intervention (PCI) ( scheduled or unscheduled) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2\n6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)\n7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or genetic hypertrophic cardiomyopathy,known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to Visit 1 and until Visit 2\n8. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2\n9. Known severe valvular heart disease (obstructive or regurgitant), as per investigator's judgment, or valvular heart disease scheduled for surgical or invasive procedures at Visit 1, or anticipated invasive treatment during the study Further exclusion criteria apply.",{"count":73,"type":22},6000,[54],"This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure.\n\nParticipants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are:\n\n* Vicadrostat\u002Fempagliflozin group: participants take vicadrostat\u002Fempagliflozin as tablets once a day.\n* Placebo\u002Fempagliflozin group: participants take placebo\u002Fempagliflozin as tablets once a day.\n\nParticipants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being.\n\nThe study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.",[28],{"date":34,"type":35},{"date":79,"type":35},"2024-06-17",{"date":81,"type":22},"2028-05-22",{"name":63,"class":42},652,{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":12,"sex":17,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100494123","efficacy-safety-and-pharmacokinetics-of-vericiguat-in-pediatric-participants-with-heart-failure-due-to-left-ventricular-systolic-dysfunction-mk-1242-036-100494123","NCT05714085","Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)","A Phase 2\u002F3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)","Inclusion Criteria:\n\n* Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.\n* Has biventricular physiology with a morphologic systemic left ventricle.\n* Is currently receiving stable medical therapy for HF.\n* Has left ventricular ejection fraction (LVEF) \\\u003C45% assessed within 3 months before randomization.\n* Is of any sex\u002Fgender, from \\>28 days to \\\u003C18 years of age inclusive. Must weigh ≥3 kg to participate.\n* Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed.\n* Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period\n\nExclusion Criteria:\n\n* Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and\u002For IV vasodilator, or recent IV diuretic.\n* Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.\n* Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.\n* Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device.\n* Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy.\n* Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations.\n* Has unoperated or residual hemodynamically significant congenital cardiac malformations.\n* Has hypertrophic or restrictive cardiomyopathy.\n* Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis.\n* Has acute coronary syndrome, undergone recent coronary intervention, or indication for coronary revascularization.\n* Has symptomatic carotid stenosis or other symptomatic cerebrovascular disease\n* Has severe pulmonary hypertension.\n* Requires continuous home oxygen for significant pulmonary disease and\u002For has known interstitial lung disease.\n* Has severe chronic kidney disease.\n* Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C.\n* Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications.\n* Has significant bone disease (other than osteopenia) that in the assessment of the investigator can alter bone formation\n* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator.\n* Has received a COVID-19 vaccination within 1 week before randomization.","29 Days","17 Years",{"count":94,"type":22},342,[96,54],"PHASE2","This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.",[28,99],"Left Ventricular Systolic Dysfunction",{"date":34,"type":35},{"date":102,"type":35},"2023-05-31",{"date":104,"type":22},"2032-04-15",{"name":106,"class":42},"Merck Sharp & Dohme LLC",108,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":116,"sex":17,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":156},"100383878","pharmacokinetics-pharmacodynamics-and-safety-profile-of-understudied-drugs-administered-to-children-per-standard-of-care-pops-100383878","NCT04278404","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs","POPS or POP02","Inclusion Criteria:\n\n1. Participant is \\\u003C 21 years of age\n2. Parent\u002F Legal Guardian\u002F Adult Participant can understand the consent process and is willing to provide informed consent\u002FHIPAA:\n3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment\n\nExclusion Criteria:\n\n1. Participant has a known pregnancy\n\n   Below exclusion criteria apply only to:\n\n   Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)\n2. Has had intermittent dialysis within previous 24 hours\n3. Has had a kidney transplant within previous 30 days\n4. Has had a liver transplant within previous 1 year\n5. Has had a stem cell transplant within previous 1 year\n6. Has had therapeutic hypothermia within previous 24 hours\n7. Has had plasmapheresis within the previous 24 hours\n8. Has a Ventricular Assist Device\n9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study",true,"0 Years","20 Years",{"count":120,"type":22},5000,"OBSERVATIONAL","The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.",[124,125,126,127,128,129,130,131,132,28,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147],"Coronavirus Infection (COVID-19)","Pulmonary Arterial Hypertension","Urinary Tract Infections in Children","Hypertension","Pain","Hyperphosphatemia","Primary Hyperaldosteronism","Edema","Hypokalemia","Hemophilia","Menorrhagia","Insomnia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Bronchopulmonary Dysplasia","Adrenal Insufficiency","Fibrinolysis; Hemorrhage","Attention Deficit Hyperactivity Disorder","Multisystem Inflammatory Syndrome in Children (MIS-C)","Kawasaki Disease","Coagulation Disorder","Down Syndrome",{"date":34,"type":35},{"date":150,"type":35},"2020-03-05",{"date":152,"type":22},"2026-12",{"name":154,"class":155},"Duke University","OTHER",52,{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":167,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":181},"100610780","barostim-enabled-neurohormonal-intervention-for-improving-treatment-of-heart-failure-100610780","NCT07232030","Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure","Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure (BENEFIT-HF)","BENEFIT-HF","Inclusion Criteria:\n\n1. Age 18 years or above\n2. NYHA Functional Class II or III heart failure symptoms at the time of screening\n3. Left ventricular ejection fraction \\\u003C 50% within 6 months of consent\n4. Heart failure accompanied by either:\n\n   * Screening local lab NT-proBNP ≥ 400 AND \\\u003C 5,000 pg\u002FmL or a BNP ≥100 AND \\\u003C 1,250 pg\u002FmL, adjusted for BMI in a stable outpatient setting OR\n   * A documented Worsening Heart Failure Event in the 6 months prior to or concurrent with consent, AND an NT-proBNP \\\u003C 5,000 pg\u002FmL or BNP \\\u003C 1,250 pg\u002FmL, adjusted for BMI in a stable outpatient setting.\n\n   Note: If participant is taking sacubitril\u002Fvalsartan (i.e. Entresto®), NT-proBNP must be used for screening eligibility. NT-proBNP and BNP to be adjusted for BMI using a 4% reduction per BMI unit over 25 kg\u002Fm2.\n5. On optimal, maximally tolerated Guideline Directed Medical Therapy (GDMT) (medications and devices) per current country specific guidelines (e.g. US follows AHA\u002FACC guidelines, Germany follows DGK\u002FESC guidelines) for the treatment of heart failure, when appropriate, throughout screening\u002Fbaseline evaluation and for at least 4 weeks prior to consent:\n\n   * No more than a 100% increase or a 50% decrease of the dosage of any one medication other than an oral diuretic.\n   * Medication changes within a drug class are allowed as long as the equivalent dosage is within the limits specified above.\n   * Unrestricted changes in oral diuretics are allowed.\n   * For participants with LVEF between 40-50%, SGLT2 inhibitors and mineralocorticoid receptor antagonists (MRAs) are encouraged and should be initiated before consent when possible.\n6. Six-minute hall walk (6MHW) ≥ 100 m AND ≤ 450 m within 15 days after consent.\n7. If female and of childbearing potential, must have a negative pregnancy test within 15 days after consent.\n8. Be an appropriate candidate for the trial and the surgical procedure as determined by the investigator or designee and the surgeon.\n9. Have signed an informed consent form for participation in this trial.\n\nExclusion Criteria:\n\n1. Any contraindications to Barostim as noted in Instructions for Use.\n2. An existing device which contraindicates Barostim specifically or unipolar therapy in general.\n3. Advanced heart failure defined by any of the following:\n\n   * AHA\u002FACC Stage D heart failure.\n   * Two or more NT-proBNP results \\>5,000 pg\u002FmL or BNP \\>1,250 pg\u002FmL in a stable outpatient setting within 3 months prior to consent. If participant is taking sacubitril\u002Fvalsartan (i.e. Entresto®), NT-proBNP must be used for screening eligibility.\n   * Current or prior continuous or intermittent intravenous positive inotrope therapy.\n   * Has received, is receiving, or scheduled to receive LVAD therapy.\n   * Solid organ or hematologic transplant or currently being evaluated for cardiac transplant.\n4. Serum estimated glomerular filtration rate (eGFR) \\\u003C 20 mL\u002Fmin\u002F1.73 m2 or has end-stage renal disease.\n5. Recurring symptomatic hypotension.\n6. Life expectancy less than one year.\n7. An inappropriate trial candidate as evidenced by at least one of the following:\n\n   * Has received or is receiving chronic dialysis.\n   * Is within WHO groups 1, 3, 4, or 5 pulmonary hypertension.\n   * Severe COPD or severe restrictive lung disease requiring chronic oral steroid use or any oxygen use.\n   * Heart failure secondary to a reversible cause, such as cardiac structural valvular disease, acute myocarditis and pericardial constriction.\n   * Active malignancy with the exception of non-melanoma skin cancers.\n   * Infiltrative cardiomyopathy (e.g. cardiac amyloidosis).\n   * Any other serious medical condition that may adversely affect the safety of the participant or validity of the trial, in the opinion of the investigator.\n8. Any of the following within 3 months prior to consent:\n\n   * Myocardial infarction\n   * Unstable angina\n   * Percutaneous coronary intervention (e.g. PTCA)\n   * Cerebral vascular accident or transient ischemic attack\n   * Cardiac arrest\n   * Surgical cardiac intervention (e.g., CABG, cardiac ablation, valve replacement, CRT\u002FICD implantation, IPG battery replacements)\n9. Surgery planned to occur within 45 days of the Barostim implant procedure. This includes pacemaker or ICD implants or battery replacements.\n10. Enrolled and active in another clinical trial (e.g. device, pharmaceutical, or biological) unless approved by the CVRx Clinical Research department.\n11. Unable or unwilling to fulfill the Protocol medication compliance and follow-up requirements, for reasons including but not limited to an unresolved history of alcohol or substance abuse or psychiatric disorder. Participant is a member of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also include university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.",{"count":166,"type":22},2500,[168],"NA","The purpose of BENEFIT-HF is to demonstrate the safety and effectiveness of Baroreflex Activation Therapy (BAT) with the Barostim System in participants with heart failure, defined as NYHA Functional Class II or III, LVEF \\\u003C 50% and NT-proBNP \\\u003C 5,000 pg\u002FmL despite being treated with Guideline-Directed Medical Therapies (medications and devices). It includes demonstration that treatment with the Barostim System, relative to usual care medical management, reduces the rate of all-cause mortality and Heart Failure Morbidity (Cardiac Transplant, Durable LVAD, or Worsening Heart Failure Events).",[28,171,172],"Heart Failure NYHA Class II","Heart Failure NYHA Class III","2026-08-19",{"date":32,"type":35},{"date":176,"type":35},"2026-04-24",{"date":178,"type":22},"2033-01",{"name":180,"class":42},"CVRx, Inc.",9,{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":116,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":23,"phases":191,"briefSummary":192,"conditions":193,"keywords":194,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":204},"100525226","improving-transitions-and-outcomes-for-heart-failure-patients-in-home-health-care-i-transfer-hf-100525226","NCT06118983","Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF)","Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF): A Type 1 Hybrid Effectiveness- Implementation Trial","Aim 1, Inclusion Criteria:\n\n* Adults hospitalized for HF who transition from participating hospitals to their partner HHC agency during the study period.\n\nAim 1, Exclusion Criteria:\n\n* Patients hospitalized for HF and discharged: home without HHC, or to an inpatient rehabilitation facility, skilled nursing facility, or hospice; patients with end stage renal disease on dialysis and those with left ventricular devices.\n\nAim 2, Inclusion Criteria:\n\n\\- Healthcare professional involved in the transition of heart failure patients from the acute care setting (hospital) to HHC (home health care) agencies, and the implementation of the I-TRANSFER-HF at one of the four participating hospital-HHC dyads.\n\nAim 2, Exclusion Criteria:\n\n\\- Healthcare professional not involved in the transition of heart failure patients from the acute care setting (hospital) to HHC (home health care) agencies, and the implementation of the I-TRANSFER-HF at one of the four participating hospital-HHC dyads.",{"count":190,"type":22},1094,[168],"This study is trying to improve the hospital-to-home transition for people with heart failure who receive home care services. The study will test an intervention called I-TRANSFER-HF, which differs from usual care by combining early home health nurse visits and outpatient medical appointments.\n\nThe study is interested in two questions:\n\n1. Is I-TRANSFER-HF better than usual care at preventing heart failure patients from returning to the hospital within 30 days?\n2. Are there parts of I-TRANSFER-HF that are easy or hard to implement in the real world?\n\nThe researchers will answer these questions by testing the intervention among pairs of hospitals and home health agencies across the country. During the study, the hospital-agency pairs will be asked to implement I-TRANSFER-HF. The researchers will then compare the results from before and after I-TRANSFER-HF was adopted. They will also interview people from these hospitals and agencies to see how I-TRANSFER-HF is being implemented under real-world conditions.",[28],[195,196],"home health care","hospital-to-home transition",{"date":34,"type":35},{"date":199,"type":35},"2026-07-28",{"date":201,"type":22},"2028-07-01",{"name":203,"class":155},"Weill Medical College of Cornell University",2,{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":23,"phases":215,"briefSummary":217,"conditions":218,"keywords":222,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":253,"locationsCount":254},"100484214","phase-4-a-preliminary-study-for-informed-100484214","NCT05585125","A Preliminary Study for INFORMED","A Preliminary Study for the Intervention of an N-of-1 Protocol For Medication Optimization","PRE-INFORMED","Inclusion Criteria:\n\n1. Ambulatory adults age ≥ 65 years with HFpEF, according to ACC\u002FAHA guidelines (signs and symptoms of heart failure AND ejection fraction ≥ 50%)\n2. Taking beta-blocker\n\nExclusion Criteria:\n\n1. Alternate cause(s) of HFpEF Syndrome:\n\n   1. Severe aortic stenosis\n   2. Moderate-severe mitral stenosis\n   3. Constrictive pericarditis\n   4. High output HF\n   5. Infiltrative cardiomyopathy\n2. Other compelling indication(s) for beta-blocker\n\n   1. Prior EF \\\u003C 50%\n   2. Hypertrophic cardiomyopathy\n   3. Angina\n   4. Acute coronary syndrome, myocardial infarction, or coronary artery bypass surgery in prior 3 years\n   5. History of ventricular tachycardia\u002Farrhythmia\n   6. Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year\n   7. Heart rate \\>100 bpm within the prior 3 months\n   8. Atrial arrhythmia with ventricular rate \\>90 per minute in the prior 3 months\n   9. Systolic blood pressure readings \\>160 mmHg within the prior 3 months, unless classified as white coat hypertension\u002Feffect (and home blood pressures below 140 mmHg)\n   10. Non-cardiac indications (e.g., migraine prevention, anxiety symptom management, hyperthyroidism, essential tumor reduction)\n3. Clinical instability (N-of-1 trials are appropriate for stable conditions only)\n\n   1. Decompensated heart failure\n   2. Hospitalization in the past 30 days\n   3. Medication changes or procedures in the prior 14 days that could confound observations\u002Fdata at PI discretion\n   4. Anticipated medication changes or procedures in subsequent 3 months that could confound observations\u002Fdata at PI discretion\n   5. Clinical instability from other medical issues\n4. Estimated life expectancy \\\u003C 6 months\n5. Moderate-severe dementia or psychiatric disorder precluding informed consent\n6. Language barrier that will preclude informed consent and ability to comprehend study procedures\n7. Non-compliance or inability to complete study procedures\n8. Enrollment in a clinical trial not approved for co-enrollment\n9. Any condition that, in the Principal Investigator or treating physician's opinion, makes the patient unsuitable for study participation",{"count":214,"type":22},18,[216],"PHASE4","Investigators will determine whether N-of-1 trials, as a pragmatic, participant-centered approach to medication optimization that can overcome key barriers of deprescribing, can lead to increased participant confidence regarding their preference to continue or discontinue beta-blockers in older adults with Heart Failure with Preserved Ejection Fraction (HFpEF).",[28,29,219,220,221],"Heart Failure With Preserved Ejection Fraction","Cardiac Failure","Heart Diseases",[223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248],"Propranolol","Metoprolol","Atenolol","Sotalol","Nadolol","Acebutolol","Carvedilol","Nebivolol","Bisoprolol","Labetalol","Pindolol","Betaxolol","Penbutolol","Adrenergic beta-Antagonists","Adrenergic Antagonists","Adrenergic Agents","Neurotransmitter Agents","Molecular Mechanisms of Pharmacological Action","Physiological Effects of Drugs","Anti-Arrhythmia Agents","Antihypertensive Agents","Vasodilator Agents","Sympatholytics","Autonomic Agents","Peripheral Nervous System Agents","Adrenergic beta-1 Receptor Antagonists",{"date":34,"type":35},{"date":251,"type":35},"2024-02-07",{"date":39,"type":22},{"name":203,"class":155},1,{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":265,"conditions":266,"keywords":267,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":281},"100650078","comparison-of-three-dimensional-and-two-dimensional-left-ventricle-strain-with-speckle-tracking-echocardiography-in-heart-failure-with-reduced-and-mildly-reduced-ejection-fraction-100650078","NCT07741305","Comparison of Three-dimensional and Two-dimensional Left Ventricle Strain With Speckle-tracking Echocardiography in Heart Failure With Reduced and Mildly Reduced Ejection Fraction","Left Ventricular Myocardial Strain Assessed by Three-dimensional Speckle-tracking Echocardiography in Heart Failure With Reduced and Mildly Reduced Ejection Fraction. A Comparison With Two-dimensional Evaluation in a Prospective Study","3V2-STEM-HF","Inclusion Criteria:\n\n* Left ventricular ejection fraction (LVEF) ≤ 49%;\n* Echocardiographic image quality judged to be at least adequate according to a four-point visual image quality scale (good, adequate, poor, or inadequate)\n\nExclusion Criteria:\n\n* Inability to maintain the correct position for acquiring echocardiographic images;\n* Arrhythmias that make multi-beat acquisition impossible (if required), such as frequent extrasystoles (supraventricular or ventricular) and atrial fibrillation;\n* Failure to visualize more than 2 segments of the left ventricle (LV), or inability to assess more than 3 segments during 3D GLS analysis;\n* Failure to sign the informed consent form and inability of the participant to understand the objectives of the study",{"count":264,"type":22},419,"This study will compare two ultrasound techniques, 2D and 3D speckle-tracking echocardiography, for measuring how well the heart muscle contracts in patients with heart failure and reduced pumping function. While 2D global longitudinal strain (GLS) is widely used and has proven value in predicting outcomes, 3D GLS may provide a more complete assessment of heart function. Researchers will enroll 419 patients from seven cardiac rehabilitation hospitals in Italy and analyze heart ultrasound images using standardized equipment and software. The study will assess how closely 2D and 3D GLS measurements agree, identify factors that influence any differences, and determine whether 3D GLS better predicts the risk of death than 2D GLS.",[28],[268,269,270,271,272],"Myocardial strain","Speckle-Tracking Echocardiography","Heart failure with reduced ejection fraction (HFrEF)","Heart failure with mildly reduced ejection fraction (HFmrEF)","Three-Dimensional echocardiography","2026-08-18",{"date":173,"type":35},{"date":276,"type":35},"2026-01-08",{"date":278,"type":22},"2027-12-31",{"name":280,"class":155},"Istituti Clinici Scientifici Maugeri SpA",5,{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":254},"100531074","contrast-echocardiography-during-exercise-to-assess-pulmonary-blood-volume-100531074","NCT06195059","Contrast Echocardiography During Exercise to Assess Pulmonary Blood Volume","Assessment of Pulmonary Blood Volume Using Contrast Echocardiography During Exercise","Inclusion Criteria:\n\n* Patients referred to the cardiac catheterization laboratory for invasive exercise right heart catheterization for evaluating exertional dyspnea. Investigators will include patients with normal or low EF, and across the spectrum of pulmonary hypertension severity.\n\nExclusion Criteria:\n\n* Patient inability or unwillingness to undergo echocardiography including a contrast method, or if echocardiography would, in the opinion of the investigator, somehow compromise the quality of data acquisition for the clinical case.\n* Prior adverse reaction to echo contrast administration",{"count":290,"type":22},800,"The purpose of this study is to evaluate whether pulmonary blood volume (PBV) derived from contrast echocardiography can serve as a non-invasive surrogate for invasive pulmonary artery wedge pressure (PAWP) during exercise. Also, to compare changes in PBV with exercise in patients with and without heart failure and pulmonary vascular disease.",[28,293],"Pulmonary Vascular Disease",{"date":32,"type":35},{"date":296,"type":35},"2024-07-30",{"date":298,"type":22},"2027-08",{"name":300,"class":155},"Mayo Clinic",{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":311,"conditions":312,"keywords":316,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":328},"100078039","product-performance-report-evaluate-long-term-reliability--performance-of-medtronic-marketed-cardiac-therapy-products-100078039","NCT00271180","Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products","Medtronic CRDM Product Performance Report","PPR","Subjects who meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.\n\nInclusion Criteria:\n\n• Subject or appropriate legal guardians provide written informed consent and\u002For authorization for access to and use of health information as required by an institution's IRB\u002FMEC\u002FREB\n\nAND one of the following must also apply:\n\n* Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application\n* Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data\n\nExclusion Criteria:\n\n* Subjects who are, or will be inaccessible for follow-up\n* Subjects with exclusion criteria required by local law (EMEA only)\n* Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant\n* Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded",{"count":310,"type":22},20000,"The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.",[313,314,28,315],"Arrhythmia","Bradycardia","Sinus Tachycardia",[317,318,319,320],"Cardiac Pacing","Implantable Cardioverter Defibrillator","pacemaker","Sinus Bradycardia",{"date":32,"type":35},{"date":323,"type":35},"1983-01",{"date":325,"type":22},"2040-12",{"name":327,"class":42},"Medtronic",333,{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":351},"100636539","phase-3-a-research-study-to-look-at-how-well-nnc0487-0111-works-compared-to-placebo-in-people-with-heart-failure-and-obesity-100636539","NCT07567001","A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity","Efficacy and Safety of NNC0487-0111 Compared to Placebo on Morbidity and Mortality in People With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity","HF-POLARIS","Inclusion Criteria:\n\n* Body Mass Index (BMI) greater than or equal to (\\>=) 30 kilograms per square metre (kg\u002Fm\\^2) at screening.\n* Diagnosis of HF with New York Heart Association (NYHA) class II-IV and in stable condition at screening, at the discretion of the investigator.\n\nFor participants with Type 2 Diabetes (T2D) at screening:\n\n\\- Diagnosed with T2D \\>= 30 days before screening.\n\nExclusion Criteria:\n\n* MI, stroke, unstable angina pectoris or worsening HF leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day of screening and until randomization.\n* HF due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, Chagas cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, or uncorrected primary valve disease of moderate or severe degree.\n* Severe pulmonary disease including primary pulmonary hypertension, chronic pulmonary embolism, or severe chronic obstructive pulmonary disease (COPD) defined as:\n* requiring home oxygen; or - ongoing oral corticosteroid therapy; or - hospital for COPD Exacerbation within 12 months prior to screening.\n* Any other condition judged by the investigator to be the cause of HF symptoms (e.g., anaemia, hypothyroidism).\n\nGlycaemia-related:\n\n* History of type 1 diabetes.\n* Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or who, at the time of screening, are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.\n* Glycated haemoglobin (HbA1c) greater than (\\>) 10 percent (%) (86 \\[millimoles per mole\\] mmol\u002Fmol) as measured by local or central laboratory at screening.",{"count":338,"type":22},5610,[54],"This study is being done to look at the safety and effect of NNC0487-0111 in people with Heart Failure with preserved Ejection Fraction (HFpEF) or Heart Failure with mildly reduced Ejection Fraction (HFmrEF) and excess body weight when compared to placebo. The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have HFpEF or HFmrEF and excess body weight. Participants will get NNC0487-0111 or placebo by injection once a week. Which treatment participants get is decided by chance. NNC0487-0111 is a new medicine that doctors cannot prescribe yet, but it has been tested in people before.",[342,28],"Obesity","2026-08-17",{"date":273,"type":35},{"date":346,"type":35},"2026-05-11",{"date":348,"type":22},"2029-08-15",{"name":350,"class":42},"Novo Nordisk A\u002FS",838,{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":23,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":365,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":366,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":4},"100633454","advancing-clinical-heart-failure-outcomes-leveraging-defibrillation-lead-implant-system-for-left-bundle-branch-area-pacing-100633454","NCT07526896","Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing","ACHIEVED LBBAP","Inclusion Criteria:\n\n* Subject meets current ACC\u002FAHA\u002FHRS guidelines for implantation of a CRT-D device.\n* Subject has documented LVEF ≤ 35% within 60 days of enrollment.\n* Subject meets the criteria for presence of Strauss-defined LBBB.\n* Subject meets NYHA classification II or III.\n* Subject is willing and able to provide written consent.\n* Subject is at least 18 years of age at the time of consent.\n* Subject is geographically stable and willing and able to complete study procedures, including follow-up visits.\n* The subject's medical records must be accessible by the enrolling site over the follow-up period.\n\nExclusion Criteria:\n\n* Subject has documented myocardial infarction before enrollment.\n* Subject has non-LBBB conduction patterns such as Right Bundle Branch Block (RBBB) or non-specific IVCD.\n* Subject has 2nd or 3rd degree AV block.\n* Subject has persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL).\n* Subject has intrinsic (non-paced) QRS duration ≤ 120ms.\n* Subject with previous or existing pacemaker (including transvenous and transcatheter pacing system), Implantable Cardioverter Defibrillator (ICD, transvenous) or CRT-D (transvenous) device or leads.\n* Subject has contraindications for screw-in transvenous lead placement (e.g., mechanical right heart valve).\n* Subject underwent valve surgery within 90 days prior to enrollment.\n* Subject is unable or unwilling to undergo baseline CMR imaging, if previously collected CMR images are unavailable or do not meet minimum acceptable criteria.\n* Subject is post-heart transplantation or is actively listed on the transplantation list.\n* Subject is implanted with a left ventricular assist device (LVAD).\n* Subject has severe renal disease.\n* Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure.\n* Subject has complex and uncorrected congenital heart disease.\n* Subject has life expectancy of less than 12 months.\n* Subject is pregnant or breastfeeding.\n* Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.",{"count":360,"type":22},110,[168],"This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator (CRT-D). This combined therapy is known as Left Bundle Branch Optimized Cardiac Resynchronization Therapy (LOT-CRT) and will be compared to LBBAP therapy over sequential 6-month periods in CRT-indicated patients with LBBB. Primary and secondary outcomes are echocardiographic changes. Exploratory assessments will include NT-proBNP and subject-reported quality of life (KCCQ). An observational treatment arm will include subjects who have not been randomized due to unsuccessful implant for real-world observational analysis",[28,364],"Systolic Bundle Branch Block, Left","NOT_YET_RECRUITING",{"date":273,"type":35},{"date":368,"type":22},"2026-08",{"date":370,"type":22},"2029-09",{"name":372,"class":42},"Medtronic Cardiac Rhythm and Heart Failure",{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":12,"sex":17,"minAge":380,"maxAge":381,"enrollmentInfo":382,"targetDuration":4,"studyType":23,"phases":384,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":254},"100609749","phase-1-a-research-study-on-the-effects-of-nnc0537-1482-in-participants-with-heart-failure-100609749","NCT07218627","A Research Study on the Effects of NNC0537-1482 in Participants With Heart Failure","A Randomised, Placebo-controlled, Double-blinded Phase 1b Study Investigating Safety, Tolerability, Pharmacokinetics and Effects on Biomarkers From Multiple Ascending Doses of NNC0537-1482 in Participants With Heart Failure","Inclusion Criteria:\n\n* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.\n* Male or females of non-childbearing potential.\n* Age 40-75 years (both inclusive) at the time of signing the informed consent.\n* Body Mass Index (BMI) range 18.5 - less than (\\\u003C) 40 kilograms per square meter (kg\u002Fm\\^2).\n* Symptomatic heart failure (New York Heart Association class II-III).\n* Stable standard of care medical therapy for heart failure with mildly reduced ejection fraction\u002Fheart failure with preserved ejection fraction (HFmrEF\u002FHFpEF) defined by:\n* No addition or removal of sodium-glucose cotransporter 2 inhibitors (SGLT2i), angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), beta-blockers (BBs,) calcium-channel blockers or aldosterone antagonists, and no substantial change in dosage (greater than or equal to (≥)100% increase\u002Fdecrease) at least 4 weeks before screening.\n* On a diuretic therapy at least 2 weeks before screening without substantial change in dosing (≥50% increase\u002Fdecrease), and on a stable diuretic therapy at least 1 week before screening.\n* On the stable doses (not in titration period) of standard medical therapy for other comorbidities\n* No hospitalizations due to heart failure (HF) between screening (V1) and randomisation (V2) confirmed at randomisation.\n* Left ventricle ejection fraction (LVEF) greater than (\\>) 40 percentage (%) documented by echocardiography at screening, or within 12 months prior to screening with no change in clinical status suggesting potential for deterioration in systolic function.\n\nAND at least one of the following:\n\n* N-terminal pro type-B natriuretic peptide (NT-proBNP) ≥125 picogram per milliliter (pg\u002FmL) (for participants with sinus rhythm) or NT-proBNP ≥375 pg\u002FmL (for participants with persistent\u002Fpermanent atrial fibrillation) at screening, and ≥1 of the following (documented by echocardiography within 12 months prior to or at screening):\n* Septal é \\\u003C7 or lateral \\\u003C10 or average E\u002Fé ≥10\n* Pulmonary artery (PA) systolic pressure \\>35 millimeters of mercury (mmHg)\n* Left atrium (LA) enlargement, (width ≥3.8 centimeter (cm) or length ≥5.0 cm or area ≥20.0 square centimeter (cm\\^2) or volume ≥55 milliliter (mL) or left atrial volume index (LAVI) ≥29 milliliter per square meter (mL\u002Fm\\^2)\n* Left ventricular hypertrophy (LVH) with septal thickness or posterior wall thickness ≥1.2 cm.\n* Hospitalization with a primary diagnosis of decompensated HF requiring intravenous loop diuretic treatment within previous 12 months, and ≥2 of the following (documented by echocardiography within 12 months prior to or at screening):\n* Septal é \\\u003C7 or lateral \\\u003C10 or average E\u002Fé ≥10\n* PA systolic pressure \\>35 mmHg\n* LA enlargement, (width ≥3.8 cm or length ≥5.0 cm or area ≥20.0 cm\\^2 or volume ≥55 mL or LAVI ≥29 mL\u002Fm\\^2)\n* LVH with septal thickness or posterior wall thickness ≥1.2 cm\n* Ongoing use of diuretic therapy for ≥30 days before screening.\n* Mean pulmonary capillary wedge pressure (PWP) ≥15 mmHg or left ventricular end-diastolic pressure (LVEDP) ≥15 mmHg documented during catheterization at rest or PA diastolic pressure measured by implantable monitor ≥15 mmHg or PWP or LVEDP ≥25 mmHg documented during catheterization at exercise.\n\nExclusion Criteria:\n\n* Any prior echo measurement of LVEF less than or equal to (≤) 40%, under stable conditions, within the past 36 months.\n* Previous participation in this study (defined as being randomised).\n* Ongoing treatment with a neprilysin inhibitor (including angiotensin receptor\u002Fneprilysin inhibitor treatment), phosphodiesterase-5 (PDE5) inhibitors or soluble guanylate cyclase (sGC) stimulators.\n* Acute coronary syndrome (ACS) (including myocardial infarction (MI)), stroke, transient ischemic attack (TIA), carotid surgery or angioplasty, cardiac surgery, other major cardiovascular surgery, or urgent percutaneous coronary intervention within the 3 months prior to screening.\n* Current acute decompensated HF requiring augmented therapy.\n* Hospitalisation within the last 90 days prior to screening with HF as the primary cause.\n* Known or suspected hypersensitivity to study intervention(s) or related products.\n* Probable alternative diagnoses that in the opinion of the investigator could account for the participant's HF symptoms (i.e., dyspnoea, fatigue) such as significant pulmonary disease (including primary pulmonary hypertension, severe chronic obstructive pulmonary disease), anaemia, hypothyroidism or obesity.\n* Systolic blood pressure outside the range of 110-160 mmHg at screening or randomisation.\n* Heart rate outside the range of 40-110 beats per minute (bpm) at screening or randomisation.\n* Orthostatic hypotension (defined as a decrease in systolic blood pressure ≥20 mmHg or a decrease in diastolic blood pressure ≥10 mmHg from a supine position to standing after 3 minutes, at screening or randomisation).\n* Atrioventricular-block II or III, QRS \\>120 milliseconds (ms), or QTcF interval \\>450 ms for men and \\>470 ms for women, or any other clinically significant abnormal electrocardiogram (ECG) results as judged by the investigator at screening or randomisation.\n* Participant has pacemaker, or implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT) or left ventricular assist device (LVAD).\n* Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate \\>110 bpm at screening or at randomisation.\n* Significant changes of prescription medicinal products (dose or frequency) or non-prescription drugs between screening and randomisation visits, per investigator's assessment.\n* Blood donation, plasma donation or blood draw any of the circumstances below:\n* 400 mL within the past 90 days prior to the day of screening\n* 50 mL within the past 30 days prior to the day of screening.\n* Coronary or carotid artery disease or valvular heart disease likely to require surgical or percutaneous intervention within the 3 months after screening.\n* Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥2 times upper limit of normal (ULN).\n* Estimated glomerular filtration (eGFR) \\\u003C20 milliliter per minute per 1.73 square meter according to 2021 CKD-EPI equation.\n* History or presence of any other disease (i.e., including malignancies) with a life expectancy of \\\u003C1 year at screening.\n* Receiving insulin for the treatment of diabetes type 1 or diabetes type 2.\n* Glycated haemoglobin (HbA1c) of \\> 8.0% as measured at screening.","40 Years","75 Years",{"count":383,"type":22},36,[25],"The study is testing a new drug (NNC0537-1482) to potentially treat people with heart failure. The purpose of the study is to see if NNC0537-1482 is safe and how it works in the body. Participants will either get NNC0537-1482 or placebo (a \"dummy drug\" without any active ingredients) and which treatment they get is decided by chance. This study will last up to 64 days with an additional screening period up to 28 days.",[28],{"date":273,"type":35},{"date":389,"type":35},"2025-10-23",{"date":391,"type":22},"2027-01-15",{"name":350,"class":42},{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":116,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":402,"conditions":403,"keywords":405,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":254},"100577624","impella-reverse-remodeling-in-end-stage-heart-failure-100577624","NCT06800716","Impella Reverse Remodeling in End-Stage Heart Failure","A Prospective Study of Recovery Mechanisms in Heart Transplant Eligible Patients With Cardiogenic Shock on Impella 5.5 Support","Inclusion Criteria:\n\n* Age 18 years or older\n* Dilated cardiomyopathy (LVEDD \\> 5.5 cm and LVEF \\\u003C25%)\n* Indication for temporary mechanical circulatory support therapy with Impella 5.5 LVAD as a bridge to transplant or bridge to transplant decision based on treating physician's discretion\n\nExclusion Criteria:\n\n* Intra-aortic balloon pump (IABP) use for more than 7 days at the time of Impella 5.5 implantation\n* Percutaneous mechanical circulatory support device, extracorporeal membrane oxygenation (ECMO) or paracorporeal ventricular assist device (VAD) support prior to Impella 5.5 implantation\n* Congenital heart disease\n* Restrictive or hypertrophic Cardiomyopathy including hypertrophic obstructive cardiomyopathy (HOCM) Amyloidosis, and Sarcoidosis\n* Evidence of acute myocarditis by endomyocardial biopsy\n* Prior heart transplantation\n* Mechanical aortic \u002F mitral valve\n* Patient with known aortic diseases such as Marfan-Syndrome, Morbus Erdheim-Gsell or others\n* Left Ventricular thrombus\n* Left Ventricular rupture\n* Cardiac tamponade\n* Presence of an Atrial or Ventricular Septal Defect\n* Severe right ventricular (RV) Failure requiring mechanical RV support\n* Severe peripheral vascular disease precluding placement of the Impella System\n* Recent stroke resulting in significant neurological deficit\n* Hypercoagulable disease precluding device implantation\n* Severe thrombocytopenia (\\\u003C50,000)\n* Contraindication to anticoagulation\n* Suspected or known pregnancy or lactating women\n* Subject belongs to a vulnerable population",{"count":401,"type":22},50,"This observational study is being done to learn more about heart attack recovery in patients supported with the Impella 5.5 left ventricular assist device (LVAD) as part of their standard of care. There are three stages in this study: screening, treatment and post treatment. There will be two phases of enrollment: First phase will enroll 10 patients; second phase will enroll an additional 40 patients. Approximately 50 participants will take part in the study at Columbia University Irving Medical Center.\n\nParticipation in this research is expected to last approximately 14 months. This time estimate includes a screening period for about 1- 3 days, treatment period of 40 days and post treatment follow-up period for 1 year. Data will be collected through 1- year after heart transplant. Clinical data (medical history, vital signs, laboratory assessments) from medical records, to perform functional testing, and to obtain blood and discarded heart tissue fromfor the purpose of this research study.\n\nParticipants will be asked to share their records for echocardiography, right heart catheterization, laboratory data and clinical information. Participants are required to complete an assessment a 6-minute walk, and hand grip strength test.",[28,404],"Cardiomyopathy",[406,407,408],"cardiogenic shock and transplant","impella","LVAD",{"date":173,"type":35},{"date":411,"type":35},"2024-12-04",{"date":413,"type":22},"2029-11",{"name":415,"class":155},"Columbia University",{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":23,"phases":425,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":435},"100489240","feasibility-and-efficacy-study-of-the-cardiopulmonary-management-cpm-system-in-patients-with-chronic-heart-failure-100489240","NCT05650541","Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure","BETA","Inclusion Criteria:\n\nHeart failure patients regardless of ejection fraction (HFpEF or HFrEF) with one or more of the following:\n\n* NYHA Class III HF\n* NYHA Class IV HF\n\nOR\n\n* NYHA Class II HF with one or more of the following:\n* Chronic Kidney Disease (eGFR\\\u003C60 within the past 6 months)\n* HF hospitalization (defined as HF listed as the major reason for hospitalization) within 9 months prior to screening visit and NT-proBNP \\> 200 pg\u002Fml\\* for patients not in AF or \\> 600 pg\u002Fml\\* for patients in AF on screening ECG+\n* NT-proBNP \\> 300 pg\u002Fml\\* for patients not in AF or \\> 900 pg\u002Fml\\* for patients in AF on the screening visit ECG+\n* Chronic obstructive pulmonary disease (COPD)\n\nExclusion Criteria:\n\n* Under 18 years of age\n\n  * Patients with severe COPD (GOLD stage III or IV)\n  * Limited mobility preventing application of device or no caregiver to assist\n  * Cognitive impairments that would limit the application and proper use of the device\n  * Skin allergies or skin sensitivities to silicone-based adhesives\n  * Pregnancy (method of assessment at the discretion of the PI)\n  * Not willing to shave chest hair if needed to apply device\n  * Patients on chronic IV ionotropic therapy - (Milrinone, Dobutamine, and Dopamine)\n  * Patients with any condition that might limit the survival to less than 1 year as assessed by the investigator\n  * No cellular coverage (Patient's Home)\\*\\*\n  * Skin breakdown on the left chest or breast area",{"count":424,"type":22},1200,[168],"The primary purpose for this study is to support the hypothesis (pilot data) that the use of the Sensinel CPM system reduces the rate of HF-related events and the related healthcare cost. The study will also measure the impact on quality of care and patient satisfaction. In order to support the primary objective, the study will compare the outcomes and costs for patients using the Sensinel CPM system against those who are not. This can either be done using institutions' averages, if available, or through a control group.",[28],{"date":173,"type":35},{"date":430,"type":35},"2023-09-22",{"date":432,"type":22},"2026-12-01",{"name":434,"class":155},"Analog Device, Inc.",7,{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":444,"enrollmentInfo":445,"targetDuration":4,"studyType":23,"phases":447,"briefSummary":448,"conditions":449,"keywords":455,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":468},"100609422","a-randomized-placebo-procedure-controlled-trial-of-the-enhancor-system-pulmonary-artery-denervation-to-evaluate-safety-and-efficacy-in-patients-with-combined-pre--and-post-capillary-pulmonary-hypertension-associated-with-left-heart-disease-100609422","NCT07214376","A Randomized Placebo-procedure Controlled Trial of the Enhancor System (PULmonary Artery Denervation) to Evaluate Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease","A Randomized Placebo-procedure Controlled Trial of the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System PULmonary Artery Denervation Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease","The PULSE-LHD","Inclusion Criteria:\n\n1. Subject is ≥18 and ≤85 years of age\n2. Subject is diagnosed with chronic HF due to left-sided heart disease for at least 6 months prior to screening (regardless of LVEF), and remains symptomatic despite maximally tolerated class I GDMT for left heart failure and CRT as appropriate per US or EU guidelines according to region of enrollment\n3. Subject is clinically stable, defined as:\n\n   * No hospitalizations for heart failure for at least 1 month; no major changes in societal guideline-recommended class I oral GDMT for left heart failure for at least 1 month; no CRT or ICD implant in the prior 3 months; and no anticipated major changes in any HF-GDMT (other than possibly diuretic dose) or planned cardiac rhythm management device implantation after the procedure\n   * SBP is ≥90 and ≤160 mmHg and resting HR is ≥50 and ≤100 bpm (≤110 bpm for atrial fibrillation)\n4. PASP (RVSP) is ≥30 mmHg on the baseline TTE.\n5. Subject has New York Heart Association (NYHA) class II, III or IVa symptoms (IVa is defined as symptoms with minimal exertion or at rest, but the patient is able to ambulate and does not require continuous intravenous medications).\n6. Subject has 6MWD at baseline ranging from 100 to 450 m limited by dyspnea or fatigue and not orthopedic or other non-HF-related issues\n7. Subject has NT-proBNP ≥600 pg\u002FmL for patients with LVEF ≤40% or ≥200 pg\u002FmL for patients with LVEF \\>40% at the time of screening (a central lab will be made available for sites that cannot measure NT-proBNP)\n8. Subject is able and willing to follow all aspects of the research protocol including medication compliance and follow-up visits and testing.\n9. Subject or the subject's legally designated representative signs an IRB\u002FEC approved informed consent form prior to study participation.\n\nExclusion Criteria:\n\n1. Subject has a life expectancy of less than 1 year due to non-cardiovascular causes.\n2. Subject has known hypertrophic cardiomyopathy with either left ventricular (LV) outflow tract obstruction or systolic anterior motion (SAM) of the anterior leaflet of the mitral valve; pericardial disease; or infiltrative or active inflammatory myocardial disease, including known amyloidosis\n3. Subject has severe stenosis or regurgitation of any heart valve, moderate or severe stenosis of the aortic valve, or any degree of stenosis of the pulmonic valve\n4. Subject has symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke in the prior 30 days or any prior stroke with a permanent residual deficit with modified Rankin Scale (mRS) score ≥4\n5. Subject has any prior intracranial hemorrhage with or without a residual deficit, or any known intracranial pathology pre-disposing to bleeding (e.g. mass, AV fistula, aneurysm, etc.)\n6. Subjects with a known bleeding diathesis or who will refuse blood transfusions\n7. Subjects allergic to heparin (including heparin induced thrombocytopenia), unless bivalirudin or argatroban can be used for procedural anticoagulation\n8. Subjects with life threatening allergy to contrast dye that cannot be adequately pre-medicated, or any prior contrast-related anaphylaxis\n9. Subject has congenital heart disease other than mitral valve prolapse or a PFO\n10. Subject had coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) in the prior 6 months or is anticipated to undergo CABG or PCI within 12 months after randomization.\n11. Subject has any pacemaker with an intracardiac sensing or pacing lead or wire implanted in the prior 3 months, or CardioMEMS HF System or other intracardiac pressure monitoring system, or cardiac contractility modulation system or baroreceptor activation therapy implanted within the prior 3 months, or any plans to implant any of these devices within 12 months after the procedure.\n12. Subject has undergone atrial fibrillation ablation within the prior 6 months or is anticipated to undergo atrial fibrillation ablation within 12 months after randomization.\n13. Subject has undergone heart valve surgery or transcatheter valve intervention within the prior 6 months or is anticipated to undergo heart valve surgery or transcatheter valve intervention (e.g., valve repair or replacement, valvuloplasty) within 12 months after randomization.\n14. Subject has any tricuspid or pulmonic valve implants (implanted annuloplasty rings are allowed).\n15. Subject has an inferior vena cava (IVC) filter implant.\n16. Subject has received a prior heart or heart-lung transplantation or is listed for heart or heart-lung transplantation or is anticipated to receive a ventricular assist device (VAD) implant within 6 months after randomization.\n17. Subjects with intracardiac thrombus on TTE.\n18. Subjects with pericardial effusion ≥10 mm on TTE\n19. Subject's PH is predominantly due to WHO Group 1, 3, 4, or 5. Note: Multifactorial features of PH may be present, but the predominant diagnosis must be WHO Group 2 CpcPH.\n20. Subject has been treated with any group 1 PAH-targeted drugs, including sotatercept, within the prior month or is planned to receive such therapy after randomization.\n21. Subject is anticipated to undergo any surgery within 6 months after randomization (other than minor surgeries requiring only local anesthesia).\n22. Subject has severe renal insufficiency (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2 by the CKD-EPI formula, or on dialysis).\n23. Subject has severe liver insufficiency (Child-Pugh classification C).\n24. Subject has platelet count \\\u003C100 × 109\u002FL.\n25. Subject has systemic inflammatory or other disease requiring long-term use of oral glucocorticoids or immunosuppressants.\n26. Subject has active infection requiring oral or intravenous antibiotics.\n27. Subject has a body mass index (BMI) \\>45 kg\u002Fm².\n28. Subjects with severe respiratory disease, defined as any disorder of the respiratory system with diffusing capacity of the lungs for carbon monoxide (DLCO) \\\u003C40% AND total lung capacity (TLC) \\\u003C60% AND forced expiratory volume in one second (FEV1) \\\u003C70% by plethysmography; OR who require ambulatory or long-term oxygen therapy\n29. Subject has known severe untreated sleep apnea. Note: Subjects with sleep apnea treated with CPAP\u002FBiPAP for at least the prior 3 months are not excluded.\n30. Subjects with pulmonary embolism or deep vein thrombosis in the prior 6 months.\n31. Subject is a pregnant or breastfeeding woman, or a woman planning to become pregnant within one year. Women of child-bearing potential must have a negative pregnancy test within 1 week of randomization.\n32. Subject is participating in another clinical trial of an investigational drug or device that has not reached its primary endpoint.\n33. Subject has severe cachexia\u002Ffrailty, substance abuse, or any other condition that the investigator believes may affect the subject's ability to comply with or complete all the study requirements including follow-up visits.\n34. Subject is a member of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, children, impoverished persons, persons in prisons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations may also include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.","85 Years",{"count":446,"type":22},750,[168],"The goal of this clinical study is to evaluate the safety and efficacy of percutaneous pulmonary artery denervation with the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) associated with left heart disease (LHD). This randomized control trial will compare the investigational device (The Enhancor System) to control (medical therapy.)\n\nParticipants who will consist of patients with chronic heart failure (HF) who are receiving maximally tolerated guideline-directed medical therapy (GDMT) for left heart failure, are clinically stable, and who have been diagnosed with CpcPH by right heart catheterization (RHC), will be treated with PADN and followed for 3 years.",[450,451,127,452,453,28,219,454],"Pulmonary Hypertension","Heart Failure With Reduced Ejection Fraction","Vascular Diseases","Cardiovascular Diseases","Heart Failure With Mid Range Ejection Fraction",[456,457,28,458,459],"Pulmonary Artery Denervation","Pulmonary Hypertension Due to Left Heart Disease","pulmonary hypertension","left heart failure","2026-08-14",{"date":273,"type":35},{"date":463,"type":22},"2026-07-30",{"date":465,"type":22},"2031-12-31",{"name":467,"class":42},"Pulnovo Medical, Inc.",6,{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":444,"enrollmentInfo":477,"targetDuration":4,"studyType":23,"phases":479,"briefSummary":480,"conditions":481,"keywords":482,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":492},"100572692","phase-3-study-with-omecamtiv-mecarbil-ck-1827452-to-treat-chronic-heart-failure-with-severely-reduced-ejection-fraction-100572692","NCT06736574","Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction","A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of Omecamtiv Mecarbil in Patients With Symptomatic Heart Failure With Severely Reduced Ejection Fraction (COMET-HF)","COMET-HF","Inclusion Criteria:\n\nAdult patients who meet all the following criteria at screening may be included in the study:\n\n* Are between ≥ 18 years and ≤ 85 years at the signing of informed consent\n* Have a history of chronic HFrEF, defined as requiring treatment for HF for a minimum of 3 months prior to screening\n* Are receiving oral loop diuretics on a regular schedule\n* Patients without AFF on screening ECG:\n\n  * LVEF \\\u003C 30% within 6 months of screening\n  * Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 1000 pg\u002FmL (BNP ≥ 300 pg\u002FmL)\n* Patients with AFF on screening ECG:\n\n  * LVEF \\\u003C 25% within 6 months of screening\n  * Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 3000 pg\u002FmL (BNP ≥ 900 pg\u002FmL)\n  * Not currently taking digoxin\n* Meet one of the following criteria for a recent HF event:\n\n  * Are currently hospitalized with the primary reason of HF\n  * Had an HF event (as defined in the primary endpoint) within 12 months prior to screening. For the purposes of a qualifying HF event, subcutaneous furosemide will be treated as equivalent to intravenous furosemide Or\n  * Had outpatient escalation of oral diuretics due to worsening signs and symptoms of heart failure plus one of two additional criteria sustained for at least 1 week: (1) at least 50% or 1.5-fold increase in daily loop-diuretic-equivalent dose; (2) the addition of a new diuretic class to a loop diuretic.\n* Are established on regional standard-of-care HF therapies for at least 30 days prior to screening\n* Systolic blood pressure ≤ 140 mmHg\n\nExclusion Criteria:\n\nAny of the following criteria will exclude potential patients from the study:\n\n* Have AFF on the screening ECG and are currently taking digoxin\n* Have had any event or procedure that may have resulted in a change in ejection fraction, including, but not limited to, acute coronary syndrome and\u002For any coronary revascularization, cardiac surgery, valve surgery, any coronary revascularization, and\u002For cardiac resynchronization, or cardiac contractility modulation therapy within 3 months of screening\n* Are admitted to a long-term care facility or hospice\n* Have a projected survival of \\\u003C 12 months due to non-cardiovascular causes based on clinical judgment\n* Are receiving intravenous inotropes or intravenous vasopressors ≤ 3 days prior to screening\n* Are receiving mechanical hemodynamic support or mechanical ventilation ≤ 7 days prior to screening\n* Are receiving intravenous diuretics, intravenous vasodilators, or supplemental oxygen therapy ≤ 12 hours prior to screening (except for nocturnal supplemental oxygen for sleep apnea or heart failure)\n* Have an estimated glomerular filtration rate (eGFR) \\\u003C 20 mL\u002Fmin\u002F1.73m2 or receiving dialysis at screening\n* Have previously had a solid organ transplant\n* Are receiving treatment in another investigational device or drug study or are within 30 days of ending such investigational treatment at screening\n* Have received omecamtiv mecarbil in a previous clinical trial\n* Are pregnant or planning pregnancy during the study period, or planning to breastfeed during treatment with IP or within 5 days after the end of treatment with IP\n* Have primary infiltrative cardiomyopathy (e.g. cardiac amyloidosis) or severe stenotic valvular disease",{"count":478,"type":22},1800,[54],"The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction.",[28,451],[483,484],"CK-1827452","omecamtiv mecarbil",{"date":273,"type":35},{"date":487,"type":35},"2024-12-19",{"date":489,"type":22},"2027-12",{"name":491,"class":42},"Cytokinetics",201,{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":501,"enrollmentInfo":502,"targetDuration":4,"studyType":23,"phases":504,"briefSummary":505,"conditions":506,"keywords":507,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":522},"100539914","investigation-of-the-briovad-system-for-the-treatment-of-left-ventricular-heart-failure-100539914","NCT06310031","Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure","Investigation of a Novel, magNetically Levitated VAD for the Treatment of refractOry Left Ventricular heArT failurE","INNOVATE","Inclusion Criteria:\n\n1. Patient is ≥ 18 years of age.\n2. Patient has received institutional approval for LVAD implantation.\n3. Patient has a body surface area (BSA) ≥ 1.2 m2.\n4. Patient is classified as NYHA Class IV with advanced heart failure refractory to advanced heart failure management or NYHA Class III with dyspnea upon mild physical activity.\n5. Patient has a left ventricular ejection fraction (LVEF) ≤ 25% or LVEF \\\u003C 30% on inotropes or temporary MCS.\n6. Patient is inotrope dependent, OR has a cardiac index (CI) ≤ 2.2 liters\u002Fmin\u002Fm2, while not on inotropes, and also meets one of the following criteria:\n\n   1. Is on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and is failing to respond or is not able to tolerate OMM; or\n   2. Has advanced heart failure for at least 14 days and is dependent on an intra-aortic balloon pump (IABP) or temporary mechanical circulatory support device (MCSD) for at least seven days.\n7. Patient has provided voluntary and informed consent.\n8. Females of childbearing age agree to use adequate contraception and have a negative pregnancy test.\n\nExclusion Criteria:\n\n1. Patient's heart failure etiology is related to restrictive or constrictive physiology (e.g., nondilated hypertrophic cardiomyopathy, cardiac amyloidosis\u002Fsenile or other infiltrative disease), complex congenital heart disease (e.g., transposition of the great vessels), uncorrected thyroid disease, and\u002For pericardial disease.\n2. Patient had a myocardial infarction within seven days of study enrollment.\n3. Patient had cardiothoracic surgery within 30 days of implant with the exception of a procedure to implant temporary MCS: Impella 5.5, Impella CP or TandemHeart.\n4. Patient has physiological conditions or comorbidities which pose high surgical risk or obstacles as determined by the Investigator.\n5. Patient has contraindications to warfarin anticoagulation.\n6. Patient has known hypo- or hypercoagulable state \\[e.g., disseminated intravascular coagulation (DIC)\\], or has a positive heparin-induced thrombocytopenia (HIT) assay and positive serotonin release assay or requires use of a non-heparin alternative anticoagulation strategy for cardiopulmonary bypass in the judgement of the Investigator.\n7. Patient is on durable MCS (e.g., LVAD or RVAD).\n8. Planned need for durable or temporary RVAD support concomitant with LVAD implant.\n9. Patient is on any form of pre-implant temporary MCS other than isolated LVAD support with an intra-aortic balloon pump, Impella 5.5, Impella CP, or TandemHeart.\n10. Patient is on any form of pre-implant temporary MCS and has a serum lactate dehydrogenase greater than 2.5 times the upper limits of normal or plasma free hemoglobin \\> 40 g\u002FdL.\n11. Patient has a history of organ transplantation.\n12. Patient has a mechanical aortic valve that may not be converted to a bioprosthetic valve at the time of VAD implant.\n13. Patient has a platelet count \\\u003C 50 k\u002Fμl.\n14. Patient has a history of confirmed untreated abdominal aortic aneurysm (AAA) \\> 5 cm in diameter.\n15. Patient has moderate or severe aortic insufficiency that will not be corrected during the VAD implant procedure.\n16. Patient has an uncontrolled systemic infection.\n17. Patient has a positive COVID 19 test within 21 days of study enrollment and at least one high risk feature including need for supplemental oxygen or ferritin \\>1000 ug\u002FL.\n18. Patient has severe end-organ dysfunction as evidenced by one or more of the following criteria:\n\n    1. Total bilirubin \\> 3.0 mg\u002FdL or cirrhosis confirmed by liver imaging or hemodynamic assessment with or without biopsy confirmation.\n    2. International normalized ratio (INR) ≥ 2.0 or PTT \\> 2.5 times control that is not related to anticoagulation therapy.\n    3. Glomerular filtration rate (GFR) \\\u003C 30 mL\u002F min\u002F1.73 m2 or need for renal replacement therapy.\n    4. Severe pulmonary arterial hypertension with a pulmonary vascular resistance (PVR) ≥ 8 Wood units that is not acutely reversible with pharmacologic intervention.\n    5. Severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease requiring home oxygen or an FEV1\u002FFVC \\\u003C 0.7 and FEV1 \\\u003C 40% predicted.\n    6. Mechanical ventilation for more than three days present at the time of study enrollment.\n    7. Documented history of pulmonary embolism or pulmonary infarct within 60 days of study enrollment.\n    8. History of stroke within 90 days of study enrollment or history of stroke with a mRS ≥ 3 at the time of study enrollment.\n    9. Symptomatic cerebrovascular disease and\u002For uncorrected carotid stenosis \\> 80%.\n    10. Significant peripheral vascular disease (PVD) accompanied by pain at rest or extremity ulceration.\n    11. Pre-albumin \\\u003C 15 mg\u002FdL and\u002For albumin \\\u003C 2.5 g\u002FdL.\n19. Patient has a non-cardiac comorbidity or illness that would limit survival to less than two years.\n20. Patient has a psychiatric disease or disorder, or irreversible cognitive dysfunction, and\u002For insufficient social support or a history of non-adherence with medical instructions that is likely to impair study compliance.\n21. Patient is participating in an interventional clinical trial that may impact or confound the results of the INNOVATE Trial.","100 Years",{"count":503,"type":22},780,[168],"The goal of this study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 Left Ventricular Assist System when used for the treatment of advanced, refractory, left ventricular heart failure.",[453,221,28],[28,508,509,510,511,512,513,514],"Left Ventricular Assist Device","Ventricular Dysfunction","Heart Disease","Cardiovascular Disease","Heart-assist Devices","Left Ventricular Assist System","BrioHealth Solutions",{"date":343,"type":35},{"date":517,"type":35},"2024-10-28",{"date":519,"type":22},"2028-12",{"name":521,"class":42},"BrioHealth Solutions, Inc.",47,{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":531,"conditions":532,"keywords":534,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":540,"locationsCount":254},"100114971","circulating-markers-that-underlie-the-transition-from-compensated-hypertrophy-to-heart-failure-100114971","NCT00762008","Circulating Markers That Underlie the Transition From Compensated Hypertrophy to Heart Failure","Inclusion Criteria:\n\n* Individuals aged \\>18yrs\n* stable or decompensated heart failure, irrespective of LVEF\n* decompensated heart failure clinical symptoms such as dyspnea, rales, edema, elevated jugular venous pressure, or ascites\n* Imaging evidence of heart failure (cardiomegaly, poor contractile function or echocardiographic Doppler evidence of diastolic dysfunction or elevated right- or left-sided filling pressures)\n* Healthy individuals with no prior history of heart attack or heart failure will be recruited to use as controls.\n\nExclusion Criteria:\n\n* Subjects who are unable to give informed consent\n* Subjects who had undergone cardiac or non-cardiac surgery in the 3 months before enrollment\n* Pregnant subjects are not excluded",{"count":530,"type":22},500,"The purpose of this research is to determine if two proteins in the blood are increased during acute heart failure. These two proteins are produced when the heart becomes dysfunctional and unable to contract normally. They may then be released into the blood and be detected by standard method in the research laboratory. Thus, the purpose of this study is to determine the relation between the change of these two proteins in the blood and the occurrence of acute heart failure. At this time, detection of an increase in these proteins in the blood is not known to be associated with any disease or heart failure.",[533,28],"Acute Decompensated Heart Failure",[535],"biomarkers",{"date":343,"type":35},{"date":538,"type":4},"2005-12",{"date":489,"type":22},{"name":541,"class":155},"UConn Health",{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":551,"briefSummary":552,"conditions":553,"keywords":554,"overallStatus":365,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":7},"100649571","phase-3-acetazolamide-in-patients-with-heart-failure-to-decrease-weight-and-relieve-symptoms-100649571","NCT07737964","ACetazolamide in Patients With Heart Failure, to Decrease Weight and relIEVE Symptoms.","ACHIEVE","Inclusion Criteria:\n\n* Age ≥ 18\n* Known HF with impaired, midly-reduced or preserved LVEF\n* Under guideline directed medical therapy for HF according to ESC Heart Failure Guidelines applicable at inclusion\n* Previously followed (or included at hospital discharge) by remote monitoring allowing daily weight by connected scale (i.e. Careline®, Optified-self®, NewCard®, Implicity®)\n* Under furosemide diuretic treatment ≥ 20mg\u002Fday for at least 30 days prior to inclusion\n* Current unplanned hospitalization or unplanned\u002Femergent consultation for acute\u002Fdecompensation HF\n\nExclusion Criteria:\n\n* Subject unable to express their consent and sign informed consent form\n* Subject not covered by public health insurance\n* Refusal to participate (absence of informed consent).\n* Subject under guardianship, legal protection, or deprived of liberty.\n* Pregnant or breastfeeding women.\n* Subject under law protection and prisoners\n* Women of child bearing potential, unless they are using an effective method of birth control (i.e. oral contraceptives, implantable contraceptives, injectable contraceptives, transdermal contraceptives, intrauterine devices, male or female condoms with spermicide, abstinence, or a sterile sexual partner)\n* Subject unable to comprehend or adhere to the protocol and follow-up\n* Concurrent participation in another interventional study.\n* Chronic ventricular assist device or heart transplant patients.\n* Acute heart failure from recent acute coronary syndrome (\\\u003C 1 month).\n* Severe chronic renal failure or dialysis (GFR \\\u003C 20 ml\u002Fmin).\n* History of renal colic, hyperchloremic acidosis and wheat allergy (other than coeliac disease)\n* Known severe hepatic insufficiency defined by a PTT \\\u003C 50% or a Child-Pugh score C and\u002For a known (clinial or biological) supplemented adrenal insufficiency\n* Intolerance to sulphonamides\n* Hypersensitivity to the active substance (Acetazolamide) or to any of the excipients (Calcium carbonate, wheat starch, gelatine, magnesium stearate)\n* Concomitant use of carbamazepine or quinidinics (hydroquinidine, quinidine)\n* Low cardiac output syndrome\u002Fcardiogenic shock.\n* Current use of acetazolamide or any other carbonic anhydrase inhibitor, including but not limited to topical ophthalmic formulations (e.g., brinzolamide, dorzolamide, methazolamide)\n* Concomitant use of lithium, valproic acid and valpromide\n* Current use of high-dose aspirin (\\>300 mg\u002Fday).\n\nNon-randomization criteria (Criteria should be controlled before patients' randomization) :\n\n* False alarm\n* Time between alarm and randomization \\> 48h\n* Subject who declines his participation\n* Loss of study treatments or unable to take it at D0\n* Hemodynamic instability justifying an urgent hospitalization\n* If applicable, positive urine pregnancy test",{"count":550,"type":22},366,[54],"Acute congestion is common in patients with heart failure (HF) and is associated with impaired renal function, reduced quality of life, hospital readmissions, and mortality. Current guidelines recommend optimal decongestion using diuretic therapy, mainly loop diuretics. Although acetazolamide has recently demonstrated efficacy in hospitalized patients, its role in ambulatory patients managed through remote telemonitoring remains to be established. This study aims to evaluate the efficacy of oral acetazolamide added to conventional treatment for decongesting ambulatory HF patients during congestive decompensations.\n\nACHIEVE is a Phase III multicenter, prospective, interventional, randomized, controlled, open-label superiority trial evaluating the efficacy of oral acetazolamide added to conventional treatment for decongestion in ambulatory patients with heart failure during congestive decompensation monitored by remote telemonitoring.\n\nThe primary objective is to assess, at Day 5, whether acetazolamide added to conventional treatment improves decongestion compared with standard treatment alone. Secondary objectives include evaluating efficacy, safety, and health economic outcomes, including quality of life, dyspnea, biological markers, unplanned consultations, hospitalizations, mortality, and hospital medical costs.",[28],[555,556,557,558,559],"heart failure","congestion","ambulatory treatment","remote telemonitoring","diuretics","2026-08-13",{"date":343,"type":35},{"date":563,"type":22},"2026-10",{"date":565,"type":22},"2029-01",{"name":567,"class":155},"University Hospital, Montpellier",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":23,"phases":577,"briefSummary":578,"conditions":579,"keywords":581,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":254},"100619836","medibeacon-transdermal-gfr-system-for-the-evaluation-of-kidney-function-in-adults-with-heart-failure-100619836","NCT07349797","MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure","An Open Label, Single-Center, Safety and Pharmacokinetic Study of Lumitrace® Injection (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR System Using the TGFR Reusable Sensor With TGFR Disposable Ring for the Evaluation of Kidney Function in Patients With Heart Failure","Inclusion Criteria:\n\n1. Age ≥18 years;\n\n   1. Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial\n   2. Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post-dose\n   3. For women of child-bearing potential, the participant should have a negative serum pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly i.e. abstinence, oral contraceptive either combined or progesterone alone; injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUD device or system or male partner sterilization\n   4. Men will not donate sperm during the study and for 1 month following the last dose of study drug.\n2. Diagnosis of symptomatic heart failure: Subject has symptomatic heart failure, ACC\u002FAHA Stage C or D, ambulatory or hospitalized for heart failure, adjudicated by a principal investigator, and meeting both of the following:\n\n   1. Clinical syndrome: Symptoms and\u002For signs consistent with heart failure (e.g., dyspnea, fatigue, edema, rales, elevated JVP), and\n   2. Objective evidence of heart failure (≥1 of):\n\n      * Left ventricular systolic dysfunction or other structural abnormalities (left atrial enlargement, left ventricular hypertrophy, diastolic dysfunction on echocardiography) or\n      * Hemodynamic evidence of elevated filling pressures by invasive or noninvasive assessment, or\n      * Elevated natriuretic peptides obtained within 90 days from enrollment: NT-proBNP ≥300 pg\u002FmL (BNP ≥100 pg\u002FmL) in sinus rhythm or NT-proBNP ≥900 pg\u002FmL (BNP ≥300 pg\u002FmL) in atrial fibrillation\n3. Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol\n4. Adequate venous access sufficient to allow blood sampling per protocol requirements\n\nExclusion Criteria:\n\nTo be eligible for the study, participants must not meet any of the criteria noted below:\n\n1. Intolerance to iohexol or iodine allergy\n2. Known allergy to relmapirazin or severe hypersensitivity reactions to adhesives or related products\n3. Administration of iohexol for cross-sectional imaging within a week from the dosing visit\n4. Limb amputation\n5. Primary kidney disease (e.g., glomerulonephritis or polycystic kidney disease)\n6. Acute kidney injury (AKI) or unstable kidney function at the time of dosing visit\n7. Clinical signs of excessive volume overload (edema grade 3-4 or ascites)\n8. Significant scarring, tattoos, or alterations in pigmentation on the sternum or other sensor location areas that would alter sensor readings\n9. Use of tanning sprays, tanning products, etc. on the upper chest within 2 weeks of dosing day\n10. Use of make-up, lotions, Vaseline or other products on the area of the upper chest on the day prior to or the day of dosing\n11. Participants who have received nephrotoxic agent or signs or symptoms suggestive of a condition that may result in acute kidney injury within two weeks of study entry.",{"count":576,"type":22},15,[168],"The goal of this clinical trial is to evaluate the accuracy and feasibility of transdermal glomerular filtration rate (tGFR) assessment using relmapirazin (Lumitrace) and the MediBeacon tGFR system compared to plasma clearance measurement of GFR in adults with heart failure.\n\nThe main question it aims to answer is the comparison of the transdermal-derived GFR for each participant using the MediBeacon tGFR to their nGFRBSA measurement.\n\nParticipants will participate in a Screening visit that will take place within 15 days of the scheduled administration of Lumitrace and iohexol. On dosing day, participants will have the tGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. Following an injection of Lumitrace and iohexol and the initiation of GFR assessments, participants will be followed at the study center for 10-24 hours. All participants will participate in a follow-up phone call approximately 7 days after the last exposure to Lumitrace and iohexol. Researchers will analyze the results to compare the tGFR values to the nGFRBSA measurements for each participant.",[580,28],"Glomerular Filtration Rate",[582,583],"Relmapirazin","Lumitrace","2026-08-12",{"date":460,"type":35},{"date":587,"type":35},"2026-08-10",{"date":589,"type":22},"2027-01",{"name":591,"class":42},"MediBeacon",{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":23,"phases":601,"briefSummary":602,"conditions":603,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":608,"locationsCount":610},"100578533","alleviant-allay-hfref-study-100578533","NCT06812533","Alleviant ALLAY-HFrEF Study","Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction","Inclusion Criteria:\n\n* LVEF ≤ 40%\n* NYHA class II, III or ambulatory IV HF\n* Receiving optimal, maximally tolerated, stable GDMT\n\nExclusion Criteria:\n\n* Advanced heart failure\n* Life-expectancy \\\u003C 12 months\n* Evidence of right heart dysfunction",{"count":600,"type":22},350,[168],"Prospective, multicenter, randomized, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFrEF.",[28],{"date":460,"type":35},{"date":606,"type":35},"2025-03-10",{"date":519,"type":22},{"name":609,"class":42},"Alleviant Medical, Inc.",67,{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":17,"minAge":380,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":23,"phases":620,"briefSummary":621,"conditions":622,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":623,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":629},"100491912","alleviant-allay-hf-study-100491912","NCT05685303","Alleviant ALLAY-HF Study","Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure","Inclusion Criteria:\n\n1. Symptomatic HFpEF\u002FHFmrEF with LVEF greater than or equal to 40%\n2. NYHA Class II, III or ambulatory IV\n3. Exercise right heart catheterization\\*\n\n   1. Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)\n   2. Exercise PVR \\\u003C 1.8 WU\n4. Ongoing stable GDMT\n\nExclusion Criteria:\n\n1. Advanced heart failure\n2. Presence of a pacemaker\n3. Evidence of right heart dysfunction",{"count":619,"type":22},700,[168],"Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF\u002FHFmrEF.",[28],{"date":460,"type":35},{"date":625,"type":35},"2023-01-10",{"date":627,"type":22},"2032-12-01",{"name":609,"class":42},93,{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":636,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":638,"enrollmentInfo":639,"targetDuration":4,"studyType":23,"phases":641,"briefSummary":642,"conditions":643,"keywords":646,"overallStatus":365,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":254},"100628463","phase-2-cortishock-p-trial-of-corticosteroids-in-inflammation-enriched-heart-failure-cardiogenic-shock-100628463","NCT07461961","CORTISHOCK-P: Trial of Corticosteroids in Inflammation-Enriched Heart Failure Cardiogenic Shock","CORTISHOCK-P: A Randomized Pilot Trial of Corticosteroids as a Pharmacologic Adjunct to Temporary Mechanical Circulatory Support in Inflammation-Enriched Heart Failure Cardiogenic Shock","CORTISHOCK-P","Inclusion Criteria:\n\nAge ≥ 18 and ≤ 80 years.\n\nHospitalized in the Intensive Care Unit (ICU).\n\nCardiogenic shock defined by clinical and hemodynamic criteria.\n\nHypotension defined by SBP \\\u003C90 mmHg for \\>30 min, MAP \\\u003C60 mmHg for \\>30 min, or requirement of vasopressors to maintain SBP ≥90 mmHg or MAP ≥60 mm Hg.\n\nHypoperfusion defined by altered mental state, cold extremities, livedo reticularis, urine output \\\u003C30 mL\u002Fh, or lactate ≥2 mmol\u002FL.\n\nIf invasive hemodynamic monitoring is available, CI \\\u003C2.2 L\u002Fmin\u002Fm2.\n\nSCAI stage B or stage C at the time of screening.\n\nFor SCAI Stage B (Beginning Shock), clinical evidence of hemodynamic instability (including relative hypotension, a decline in SBP of ≥20-30 mmHg, or MAP \\\u003C20% from baseline, or tachycardia) without hypoperfusion (normal lactate).\n\nFor SCAI Stage B, hypotension SBP \\\u003C90 mmHg or MAP \\\u003C60 mmHg or \\> 30 mmHg drop from baseline, or tachycardia heart rate ≥100 bpm.\n\nFor SCAI Stage C, requiring only one vasoactive\u002Finotrope and\u002For IABP from admission with CS until randomization, AND Vasoactive-inotropic score (VIS) \\\u003C40.\n\nFor SCAI Stage C, NONE of the following criteria of deterioration from admission until randomization: failure to respond to initial single vasopressor\u002Finotrope drug and addition of a second drug, or failure to respond to IABP and need for new MCS device.\n\nFor SCAI Stage C, use of vasoactive agents at the time of randomization must not show: low starting dose with escalation, intermediate starting dose without escalation or de-escalation, or high starting dose with de-escalation.\n\nFor SCAI Stage C, worst lactate 2 - 5 mmol\u002FL and increase ≥ 100% from baseline lactate ≥ 2mmol\u002FL or worst lactate ≥5mmol\u002FL.\n\nDocumented history of chronic heart failure with reduced ejection fraction (LVEF \\\u003C40%).\n\nEtiology of cardiogenic shock must be congestive heart failure decompensation (HF-CS).\n\nhsCRP ≥20 mg\u002FL, reflecting a pro-inflammatory state.\n\nLess than 48 hours since admission\n\nExclusion Criteria:\n\nCardiogenic shock caused by acute myocardial infarction (AMI-CS).\n\nOther special conditions causing cardiogenic shock, including post-cardiotomy CS, peripartum, adrenergic, valvular, restrictive, post-embolic, conduction or rhythm disorders, or related to cardiotropic drug intoxication.\n\nCirculatory shock of another cause, such as septic, hemorrhagic, or anaphylactic shock.\n\nShock post-cardiac arrest.\n\nOnset of cardiogenic shock \\>48 hours.\n\nSCAI stage A, D, or E at the time of enrollment.\n\nSevere hyperglycemia at baseline, defined as blood glucose ≥300 mg\u002FdL despite insulin therapy.\n\nOngoing uncontrollable infection, suspected concomitant sepsis, or mixed septic-cardiogenic shock.\n\nIschemic hepatitis or ALT \\>500 IU\u002FL due to causes other than suspected hypoperfusion.\n\nSevere refractory acute kidney injury (AKI) at baseline, defined as new persistent anuria (urine output \\\u003C50 mL\u002Fday) or refractory AKI requiring new emergent renal replacement therapy.\n\nKnown allergy to methylprednisolone or other steroid analogues.\n\nCardiac transplant patient or on the transplant list.\n\nPatient planned for implantation of a durable LVAD.\n\nMoribund patients (SAPS2 \\>90) or predicated mortality \\>90% within 30 days.\n\nSigns of extremis, including lactate \\>5 mmol\u002FL, pH \\\u003C7.2, or refractory shock requiring escalation to \\>3 vasopressors at screening.\n\nPregnant woman, parturient, or breastfeeding mother.\n\nAdult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice).","80 Years",{"count":640,"type":22},30,[96],"This pilot study investigates whether giving a short course of intravenous corticosteroids (methylprednisolone) alongside standard medical care can help patients recovering from heart failure-related cardiogenic shock. Heart failure-related cardiogenic shock happens when chronic heart dysfunction causes poor blood circulation and congestion throughout the body. Often, this condition triggers severe inflammation, making it harder for the heart and other organs to recover, even when temporary mechanical heart pumps are used to support blood flow.\n\nThe study aims to see if reducing this inflammation with corticosteroids is safe and can help patients get better faster. Researchers will enroll 30 adult patients hospitalized with early-stage (SCAI Stage B or C) cardiogenic shock related to heart failure. To participate, patients must also show high levels of inflammation in their blood, specifically a high-sensitivity C-reactive protein (hsCRP) level of 20 mg\u002FL or higher\n\nParticipants will be randomly assigned by chance to one of two groups. One group will receive the standard of care alone. The other group will receive the standard of care plus a 7-day course of intravenous methylprednisolone.\n\nThe main goal of the study is to measure the change in inflammation levels (hsCRP) over 7 days. Researchers will also monitor how well the patients' organs recover, track their need for blood pressure medications or mechanical heart pumps, and monitor for any side effects to ensure the treatment is safe",[644,28,645],"Cardiogenic Shock","Inflammation",[647,648,649,650],"cardiogenic shock","heart failure cardiogenic shock","inflammation","corticosteroids",{"date":560,"type":35},{"date":653,"type":22},"2026-10-01",{"date":655,"type":22},"2029-02-01",{"name":657,"class":155},"Brigham and Women's Hospital"]