[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiovascular-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiovascular-diseases":33},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,435,0,25,[9,50,79,110,132,163,192,212,235,261,293,323,343,363,397,420,441,469,505,525,548,574,600,633,653],{"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":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100641631","fibrotic-disease-activity-in-cardiopulmonary-disorders-using-18f-fibroblast-activation-protein-inhibitor-18f-fapi-74-petct-imaging-100641631",false,"NCT07613099","Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET\u002FCT Imaging","Evaluation of Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74 PET\u002FCT Imaging)","* INCLUSION CRITERIA\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Participant \\>=18 years old\n4. Has a specific diagnosis of a cardiopulmonary and\u002For vascular disease that puts them at risk of developing or having developed tissue fibrosis.\n5. Has undergone prior imaging of lungs, heart, and\u002For vasculature with chest CT\n6. Able to lie on the PET\u002FCT scanner for imaging up to 45 minutes.\n7. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of FAPI-PET\u002FCT or the FDG PET\u002FCT scan.\n8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of FAPI-PET\u002FCT or the FDG PET\u002FCT scan.\n9. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FAPI-74 or other agents used in the study.\n2. Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements\n3. Pregnancy or lactation\n4. Women able to become pregnant or men actively trying to father a child and are unwilling to use an effective form of birth control during the study and 4 weeks after the last 18F-FAPI-74 PET\u002FCT scan or the FDG PET\u002FCT scan.\n5. Subjects with severe claustrophobia unresponsive to oral anxiolytics.\n6. Subjects weighing \\> 350 lbs (weight limit for PET scanner table), or unable to fit within the imaging gantry","ALL","18 Years","100 Years",{"count":21,"type":22},210,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Background:\n\nInjury or diseases of the heart and lung can sometimes cause scar tissue (fibrosis) to build up in those organs. Current imaging scans can see this scar tissue once it has formed, but researchers want to find a way to detect the fibrosis in its earliest stages, while there might still be time to prevent serious damage. A new tracer (a radioactive substance injected during imaging scans) may be able to help.\n\nObjective:\n\nTo test a new tracer (18F-FAPI-74) during imaging scans in people with heart or lung disease.\n\nEligibility:\n\nPeople aged 18 years and older with lung or heart disease that may cause scarring in those organs.\n\nDesign:\n\nParticipants will have 6 clinic visits over 2 years.\n\nParticipants will be screened: They will have blood tests and tests of their heart and lung function. Those with heart disease will have a magnetic resonance imaging (MRI) scan of the heart.\n\nThe study tracer will be used with positron emission tomography (PET)\u002Fcomputed tomography (CT) scans. The study tracer will be injected into a vein in the arm. Participants will lie on a padded bed that slides through a donut-shaped machine.\n\nParticipants will have scans with the study tracer 2 times, 8 to 12 months apart. They will also have standard CT scans and blood tests during these visits. They will also have blood tests at 3 and 6 months between these visits.\n\nParticipants will have a follow-up visit after 18 to 24 months. The study scans, MRI and standard CT scans, and lung function tests may be repeated....",[28,29,30,31,32,33],"Allogeneic Stem Cell Transplantation","Lung Allograft Transplantation","Interstitial Lung Disease","Acute Lung Injury","Pulmonary Arterial Hypertension","Cardiovascular Diseases",[35,36],"Fibroblast activation protein (FAP) FAPI\u002FPET","Fibrotic Disease Activity","RECRUITING","2026-08-20",{"date":40,"type":41},"2026-08-21","ACTUAL",{"date":43,"type":22},"2026-08-26",{"date":45,"type":22},"2033-05-26",{"name":47,"class":48},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100641216","phase-3-a-study-to-see-if-lepodisiran-can-reduce-plaque-in-coronary-arteries-of-adults-with-elevated-lpa-who-have-had-heart-events-or-are-at-high-risk-100641216","NCT07613294","A Study to See if Lepodisiran Can Reduce Plaque in Coronary Arteries of Adults With Elevated Lp(a) Who Have Had Heart Events or Are at High Risk","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Lepodisiran to Investigate the Effect on Coronary Plaque in Adults With Elevated Lp(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event","ACCLAIM-CTA","Inclusion Criteria:\n\n* Have an Lp(a) ≥175 nmol\u002FL\n* Have established cardiovascular (CV) disease or are at risk for a first CV event\n* Have angiographic evidence of coronary artery disease on screening CCTA\n* If taking lipid-lowering medications, inclusive of statins or prescription strength niacin and PCSK9 inhibitors, these should be stable for 8 weeks\n\nExclusion Criteria:\n\n* Have had a major CV event less than 60 days before measurement of the Lp(a) level used for eligibility or uncontrolled high blood pressure at screening\n* Have moderate to severe renal dysfunction\n* Have severe heart failure\n* Have a history of coronary artery bypass graft surgery (CABG)\n* Have a planned coronary angiography, percutaneous coronary intervention (PCI), coronary artery bypass graft, or valvular intervention\n* Have had a procedure to remove lipoproteins from the blood or received therapy specifically targeting Lp(a)\n* Are unable to safely undergo CCTA due to medication intolerance, contrast allergies, or anatomical\u002Ftechnical factors","45 Years","80 Years",{"count":61,"type":22},252,[25],"Lipoprotein(a), also known as Lp(a), is a protein that carries cholesterol and proteins in your blood. People with high Lp(a) have a higher risk for heart disease. The main purpose of the study is to investigate how lepodisiran, compared to a placebo, affects the amount and type of plaque in the heart's vessels using an imaging technology known as Coronary Computed Tomography Angiography (CCTA) in adults who have high levels of Lp(a).\n\nParticipation will last about 120 weeks.",[65,33,66],"Atherosclerosis","Lipoprotein(a)",[68,69],"CCTA","Coronary plaque burden",{"date":40,"type":41},{"date":72,"type":41},"2026-06-01",{"date":74,"type":22},"2029-12",{"name":76,"class":77},"Eli Lilly and Company","INDUSTRY",58,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":109},"100640738","low-intensity-focused-ultrasound-targeting-the-stellate-ganglion-for-regulating-autonomic-nerve-function-and-sleep-quality-in-perioperative-patients-with-cardiovascular-diseases-100640738","NCT07595068","Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases","Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases: A Multicenter, Double-Blind, Randomized Controlled Trial","US-REST","Inclusion Criteria:\n\n1. Diagnosed with cardiovascular disease (CVD) and scheduled to undergo cardiology-related surgical treatment\n2. Able to receive and tolerate the aforementioned cardiology-related surgical treatment\n3. Aged between 18 and 79 years (inclusive), with no restriction on gender\n4. Agree to accept random allocation of the treatment strategies\n5. With clear consciousness, no severe mental disorders or cognitive impairment; voluntarily sign the written informed consent form (ICF) and are willing to actively cooperate with the study treatment\n\nExclusion Criteria:\n\n1. Have used sedative-hypnotic drugs, antipsychotic drugs, opioid analgesics, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), central nervous system (CNS) stimulant drugs, or any other medications that alter sleep architecture within the past 30 days\n2. Have a history of cervical infection, trauma, severe cervical deformity, or prior cervical surgery\n3. Unable to complete the daily study intervention as required by the trial protocol\n4. Are participating in another clinical trial, or have participated in other clinical trials with interventions that may interfere with the results of this study\n5. Have undergone major surgery or general anesthesia within the past 30 days\n6. Have a history of alcohol abuse\n7. Are female subjects who are pregnant or lactating, or plan to become pregnant during the study period\n8. Have severe cognitive impairment, severe psychiatric disorders, epilepsy, or other related neurological disorders\n9. Have concomitant malignant tumor or severe dysfunction of vital organs\n10. Have active systemic infection\n11. Have significant bleeding tendency, or renal failure undergoing regular hemodialysis\n12. Are deemed unsuitable for the trial by the investigator for any other reason -","79 Years",{"count":89,"type":22},200,[91],"NA","The goal of this multicenter, double-blind, randomized controlled trial is to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) stellate ganglion modulation for improving autonomic function and sleep quality in perioperative cardiovascular disease patients.\n\nThe main questions it aims to answer are:\n\n1. Does LIFU improve heart rate variability and sleep characteristics from baseline at 3-7 days post-surgery compared to sham ultrasound?\n2. Does LIFU improve serological markers, vital signs, Pittsburgh Sleep Quality Index (PSQI), and reduce \\>30-second perioperative arrhythmias?\n3. What is the safety profile of LIFU in this population? 200 eligible patients will be randomized 1:1 to receive either active LIFU (2.0W, 1MHz, 50% duty cycle, 30min daily for 3-7 days) plus standard care, or identical sham ultrasound plus standard care. A four-party double-blind design (subjects, operators, assessors, analysts) will be implemented. The study will run from May 1, 2026 to April 1, 2027 at 6 centers in China.\n\nParticipants will:\n\n1. Complete pre-surgery screening and baseline assessments (PSQI, 12h ECG\u002Fsleep monitoring, residual blood sample collection)\n2. Receive daily assigned ultrasound intervention for 3-7 consecutive days post-surgery\n3. Undergo 72h continuous ECG monitoring post-surgery, and repeat assessments at 3-7 days\n4. Have all adverse events and arrhythmias recorded throughout the study\n5. May withdraw voluntarily at any time without affecting routine medical care",[94,33],"Atrial Fibrillation (AF)",[96,33,97,98,99],"Low-Intensity Focused Ultrasound","Stellate Ganglion","Autonomic Nervous Function","Sleep Quality","2026-08-19",{"date":40,"type":41},{"date":103,"type":41},"2026-05-20",{"date":105,"type":22},"2027-04-01",{"name":107,"class":108},"Renmin Hospital of Wuhan University","OTHER",7,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100597898","phase-3-easi-protkt---a-study-to-test-vicadrostat-bi-690517-taken-together-with-empagliflozin-in-people-with-type-2-diabetes-high-blood-pressure-and-cardiovascular-disease-100597898","NCT07064473","EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease","EASi-PROTKT™ - 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 Type 2 Diabetes, Hypertension and Established Cardiovascular Disease","Inclusion Criteria :\n\n* At least 18 years old at time of consent\n* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n* Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).\n* Participants with medical history of hypertension and on active pharmacological treatment\n* Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment\n* Established cardiovascular (CV) disease and on active pharmacological treatment\n* At least one additional risk factor for developing heart failure (HF)\n\nExclusion Criteria:\n\n* History of HF or hospitalization for HF or treatment of HF\n* Atrial fibrillation or Atrial flutter with a resting heart rate \\>110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)\n* Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)\n* Treatment with an Mineralocorticoid receptor antagonist (MRA)\n* Treatment with amiloride or other potassium-sparing diuretic\n* Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:\n\n  * A direct renin inhibitor (e.g. aliskiren)\n  * More than one Angiotensin-converting enzyme inhibitor (ACEi) and\u002For Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously\n  * Other aldosterone synthase inhibitors (e.g. baxdrostat)\n  * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply.",{"count":118,"type":22},11800,[25],"This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine.\n\nParticipants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo.\n\nParticipants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.",[122,123,33],"Diabetes Mellitus, Type 2","Hypertension",{"date":38,"type":41},{"date":126,"type":41},"2025-07-22",{"date":128,"type":22},"2029-12-21",{"name":130,"class":77},"Boehringer Ingelheim",1147,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":140,"sex":17,"minAge":141,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":145,"conditions":146,"keywords":150,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":49},"100555393","northwestern-tempus-ai-enabled-electrocardiography-notable-trial-100555393","NCT06511505","NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial","NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial: A Pragmatic, Real-world Study of an Artificial-intelligence Enabled Electrocardiogram Algorithms to Improve the Diagnosis of Cardiovascular Disease","NOTABLE","Inclusion Criteria:\n\n1. Atrial fibrillation algorithm\n\n   1. Age 65 or over\n   2. ECG obtained as part of routine clinical care\n2. Structural heart disease algorithm\n\n   1. Age 40 or over\n   2. ECG obtained as part of routine clinical care\n\nExclusion Criteria:\n\n1. Atrial fibrillation algorithm\n\n   1. No history of AF\n   2. No permanent pacemaker (PPM) or implantable cardioverter defibrillator (ICD)\n   3. No recent cardiac surgery (within the preceding 30 days)\n2. Structural heart disease algorithm\n\n   1. No history of SHD\n   2. No echocardiogram within the past 1 year",true,"40 Years",{"count":143,"type":22},1000,[91],"The goal of this clinical trial is to determine if a machine learning\u002Fartificial intelligence (AI)-based electrocardiogram (ECG) algorithm (rECHOmmend and ECG-AF) can identify undiagnosed cardiovascular disease in patients. It will also examine the safety and effectiveness of using this AI-based tool in a clinical setting. The main questions it aims to answer are:\n\n1. Can the AI-based ECG algorithm improve the detection of atrial fibrillation and structural heart disease?\n2. How does the use of this algorithm affect clinical decision-making and patient outcomes?\n\nResearchers will compare the outcomes of healthcare providers who receive the AI-based ECG results to those who do not. Participants (healthcare providers) will:\n\nBe randomized into two groups: one that receives AI-based ECG results and one that does not.\n\nIn the intervention group, receive an assessment of their patient's risk of atrial fibrillation or structural heart disease with each ordered ECG.\n\nDecide whether to perform further clinical evaluation based on the AI-generated risk assessment as part of routine clinical care.",[147,33,148,149],"Atrial Fibrillation","Arrhythmia","Valvular Disease",[151,152,153,154,155],"early detection","artificial intelligence","structural heart disease","atrial fibrillation","cardiac diagnostics",{"date":38,"type":41},{"date":158,"type":41},"2024-09-16",{"date":160,"type":22},"2028-09",{"name":162,"class":108},"Northwestern University",{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":140,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":23,"phases":172,"briefSummary":173,"conditions":174,"keywords":177,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":49},"100584635","groceries-for-residents-of-southeastern-usa-to-stop-hypertension-100584635","NCT06891911","Groceries for Residents of Southeastern USA to Stop Hypertension","GoFreshSE","Inclusion Criteria:\n\n1. Resting systolic blood pressure of 120 to \\\u003C160 mm Hg and diastolic blood pressure \\\u003C110 mm Hg\n2. Resident of Florida, Georgia, and Tennessee\n3. Able to receive home-delivered groceries or pick them up at a convenient location and willing to eat only the groceries provided over a 4-week period\n4. Have access to refrigeration, cooking appliances, and Wi-Fi\u002Fcellular service\n5. Have access to mobile device or computer to be able to conduct grocery orders via video conference and send\u002Freceive text messages\n6. Willing and able to complete required measurement procedures\n7. Able to provide consent for the study\n8. Has access to a primary care team, urgent care center, or emergency room the study team can refer to for follow up care if warranted during the study\n\nExclusion Criteria:\n\nA. Laboratory Exclusions:\n\n1. Serum potassium ≥5.4 mmol\u002FL or \\\u003C3.5 mmol\u002FL\n2. Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin per 1.73 m\\^2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n3. Hemoglobin A1c ≥6.5%\n\nB. Medication Exclusions:\n\nUnstable doses (i.e. a change in the 6 months prior to screening or randomization or planning to start within study period) of the following:\n\n1. GLP-1 and dual GLP-1\u002FGIP receptor agonists\n2. Anti-hypertension medications\n3. Sodium-glucose co-transporter 2 (SGLT2) inhibitors\n4. Glucose lowering medications\n\nUse of any of the following medications:\n\n1. Potassium supplement, except if part of a multivitamin\n2. Warfarin (Coumadin)\n3. Chronic oral corticosteroid (intermittent use is okay)\n4. Weight loss medications (non-GLP-1 receptor agonists)\n5. Sulfonylurea or any insulin use\n\nAny medication not compatible with participation as determined by the investigators\n\nC. Physical Exclusions:\n\n1. Systolic blood pressure: \\\u003C120 or ≥160 mm Hg or diastolic blood pressure ≥110 mm Hg\n2. Arm circumference \\>52 cm (or the upper limit of the validated BP device)\n\nD. Medical History Exclusions:\n\n1. Self-reported weight loss or gain of 15 pounds during prior 2 months\n2. Active cardiovascular disease or any event in the prior 6 months, including coronary artery bypass grafting (CABG), percutaneous transluminal coronary angioplasty (PTCA), myocardial infarction (MI), cerebrovascular accident (CVA), or congestive heart failure (CHF) exacerbation requiring hospital admission\n3. Cancer diagnosis or treatment in the last 2 years (non-melanoma skin cancer or localized breast or prostate or bladder cancer not requiring systemic therapy is acceptable)\n4. Gastrointestinal surgery or history that affects nutrition absorption or requires a specific diet that will deter DASH diet adherence\n5. Pregnancy or lactation or planned pregnancy during the study period\n6. Any emergency department (ED) visit for asthma or chronic obstructive pulmonary disease (COPD) in the last 6 months\n7. Hypoglycemia hospitalization in the last 12 months\n8. Any other serious illness or condition not compatible with participation as determined by the investigators\n\nE. Lifestyle and Other Exclusions:\n\n1. Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence\n2. Consumption of more than 14 alcoholic drinks per week or consumption of more than 6 drinks on one or more occasion per week\n3. Active substance use disorder that would interfere with participation\n4. Extreme food insecurity\n5. Participation in or planning to start weight loss program\n6. Current participation in another clinical trial that could interfere with the study protocol\n7. Anticipated change in residence outside of eligible states prior to the end of the study\n8. Families with more than 6 adults at dinner time (children count as half an adult)\n\nF. Investigator discretion",{"count":171,"type":22},150,[91],"GoFreshSE is a randomized control trial, testing the effects of a home-delivered, dietitian-assisted, DASH-patterned grocery intervention on blood pressure in adults with high blood pressure in Florida, Georgia, and Tennessee.",[123,175,33,176],"Elevated Blood Pressure","Dietary Intervention",[123,178,179,180,181,182,183],"Dash Diet","Low Sodium","Diet","Nutrition","Clinical trial","Dietitian","2026-08-18",{"date":100,"type":41},{"date":187,"type":41},"2025-10-14",{"date":189,"type":22},"2026-12",{"name":191,"class":108},"Beth Israel Deaconess Medical Center",{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":140,"sex":17,"minAge":198,"maxAge":19,"enrollmentInfo":199,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":49},"100558565","thrombosis-and-inflammation-in-vessels-initiative-tivi-100558565","NCT06552767","Thrombosis and Inflammation in Vessels Initiative (TIVI)","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Age \\>= 5 years at the time of consent\n* Ability of subject or Legally Authorized Representative (LAR) as applicable to understand and the willingness to sign a written informed consent document\n\nIn addition, the following cohort-specific inclusion criteria apply:\n\nAffected Subjects:\n\n-Known or possible thrombotic, immune, or vascular disorder after review of the subject s medical records and\u002For discussion of medical history\n\nRelatives of Affected Subjects:\n\n-Being a relative of an affected subject\n\nUnrelated Healthy Controls:\n\n-In good general health as evidenced by medical history\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n-Any condition that in the opinion of the Investigator would warrant exclusion\n\nUnrelated Healthy Controls:\n\n* Unrelated healthy volunteers who decline to have blood drawn and\u002For tissue studies or who do not consent to have samples stored for future research\n* Cognitively impaired individuals","5 Years",{"count":143,"type":22},"OBSERVATIONAL","Background:\n\nDiseases related to the immune system, blood clots, and blood vessels can affect every part of the body. These diseases are now known to be interrelated: People who have strokes, blood clots in their legs, or autoimmune disease, for example, are at greater risk of complications in the heart, brain, and other organs. Researchers want to learn more about how these diseases start, how they change over time, and how they affect different organs.\n\nObjective:\n\nTo learn more about how inflammation and diseases of the blood vessels start and how they change over time.\n\nEligibility:\n\nPeople aged 5 years and older with a disease related to blood clots, the immune system, or blood vessels. Healthy relatives of people with these diseases and unrelated healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have a baseline visit: They will provide a medical history, physical exam and blood test. All other tests and procedures are optional; these may be spread over more than 1 day:\n\nTests of heart and lung function.\n\nFill in a family tree form.\n\nImaging scans\n\nTreadmill or bike stress tests and a 6-minute walk test.\n\nTests of blood pressure and the flow of blood through vessels.\n\nPhotos of the face and body.\n\nEye exams, with photos taken of the retina.\n\nSaliva and urine samples.\n\nBiopsies (tissues samples) of the skin and fat.\n\nTests of thinking and mental function.\n\nEvaluations by other medical specialists.\n\nParticipants may opt to return for repeat testing for up to 90 months (7.5 years).\n\nSome visits may be done by telehealth.",[33,203],"Vascular Diseases",[205],"Vascular",{"date":100,"type":41},{"date":208,"type":41},"2024-11-22",{"date":210,"type":22},"2034-01-30",{"name":47,"class":48},{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":17,"minAge":141,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":223,"conditions":224,"keywords":225,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":49},"100417429","phase-4-secondhand-tobacco-smoke-and-cardiovascular-disease-100417429","NCT04715568","Secondhand Tobacco Smoke and Cardiovascular Disease","Occult Cardiovascular Disease With Chronic Exposure to Secondhand Tobacco Smoke","Inclusion Criteria:\n\n* Must be able to understand and provide informed consent.\n* Adults \\>= 40 years of age.\n* Must have a history of occupational exposure to secondhand tobacco smoke for at least 5 years such as flight attendants who worked for airlines before the smoking ban on aircrafts went into effect or casino workers who worked at casinos with no smoke-free policies.\n* Must have never smoked or have a remote history of light smoking defined as follows:\n\n  * Lifetime smoking history equivalent to \\\u003C 1 pack-year and\n  * No smoking history for \\>= 20 years at the time of enrollment.\n\nExclusion Criteria:\n\n* Inability or unwillingness of a participant to give written informed consent or comply with study protocol.\n* Subject is pregnant, breast-feeding, or plans to become pregnant.\n* Current therapy with angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).\n* Known intolerance to ACE inhibitor or ARB.\n* History of angioedema.\n* Conventional indication for ACE inhibitor or ARB (e.g., history of myocardial infarction, known cardiomyopathy).\n* Blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic while standing or sitting.\n* Known unilateral or bilateral renal artery stenosis higher than 70%.\n* Renal insufficiency (Creatinine Clearance \\\u003C30 mL\u002Fmin by Cockcroft-Gault calculation).\n* Current regular use of NSAIDs defined as daily use on 5 or more days of the week for more than one month.\n* Potassium supplementation or serum potassium level of 5.0 milliequivalents (mEq)\u002FdL or higher at V1.\n* Current use of a potassium sparing diuretic.\n* History of clinically overt cardiovascular disease including: stable or unstable angina; chest discomfort and dyspnea with baseline exertion; symptomatic coronary artery disease (as defined by history of abnormal stress test; cardiac catheterization showing \\>70% coronary artery stenosis; history of revascularization; pathologic Q waves on EKG); poorly controlled resting hypertension (SBP\\>160\u002F DBP\\>95); congestive heart failure (CHF) (as defined by left ventricular ejection fraction (LVEF) \\\u003C55%; physical exam findings of CHF; symptomatic pulmonary edema); significant (\\>mild) valvular heart disease; congenital heart disease; cardiac arrhythmias including frequent premature atrial or ventricular contractions (\\>5 per minute).\n* History of clinically overt pulmonary disease that may interfere with study procedures, including: greater than mild asthma, COPD, emphysema, chronic interstitial lung disease, and pulmonary hypertension.\n* Neuromuscular disorders or physical disability to perform exercise testing using an ergometer.\n* Significant history of recreational drug use other than marijuana as defined by: recreational drug use within the last 30 years of recruitment (or) recreational drug use at a frequency of more than once a month before 30 years.\n* Marijuana use more than once a week.\n* Other uncontrolled chronic illnesses which in the judgment of the study physician would interfere with completing study procedures.\n* Failure to keep screening appointments or other indicators of non-adherence.\n* Concomitant participation in another interventional study.\n* Subjects with BMI \\\u003C15 or \\>40 kg\u002Fm2.\n* MRI Scan Participation Exclusion Criteria - The participants will be excluded from the MRI portion of the study if they have a metallic object embedded or implanted in their body that is incompatible with Magnetic Resonance (MR) scanning, including MR incompatible pacemaker or defibrillator.",{"count":220,"type":22},100,[222],"PHASE4","This is a double-blind randomized placebo-controlled crossover clinical trial of efficacy and safety of an FDA-approved angiotensin receptor blocker (losartan) to improve cardiopulmonary outcomes in individuals with pre-Chronic Obstructive Pulmonary Disease (COPD) due to prolonged exposure to secondhand tobacco smoke.",[33,123],[226],"Second Hand Tobacco Smoke","2026-08-17",{"date":100,"type":41},{"date":230,"type":41},"2021-03-30",{"date":232,"type":22},"2026-12-31",{"name":234,"class":108},"University of California, San Francisco",{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":17,"minAge":243,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":246,"conditions":247,"keywords":249,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":258,"locationsCount":260},"100619444","screening-for-change-early-risk-detection-and-integrated-prevention-for-diabetes-and-cardiovascular-diseases-in-the-marche-region-100619444","NCT07344701","\"Screening for Change: Early Risk Detection and Integrated Prevention for Diabetes and Cardiovascular Diseases in the Marche Region\"","Early Risk Detection of Type 2 Diabetes and Cardiovascular Diseases: an Italian Cohort Study","JAC_AST","Inclusion Criteria:\n\n* Citizens resident in Ascoli Piceno province\n* People turning 50 in 2026\n* Capacity to consent\n* Fulfilling and signing the informed consent related to the participation to the study.\n\nExclusion Criteria:\n\n* a concomitant diagnosis of DM and a previous CVD major event (one or more between Myocardial infarction, Haemorrhagic and\u002For ischaemic stroke, Revascularization interventions, as percutaneous coronary intervention\u002Fcoronary artery bypass graft)\n* Failure to meet the inclusion criteria\n* Lack of written informed consent.","50 Years",{"count":245,"type":22},2951,"This study aims to test the feasibility of a new systematic screening program to allow the early detection of individuals aged 50 years at risk of type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVDs) in the resident in the province of Ascoli Piceno and without previous diagnosis, using the CUORE and FINDRISDC tools developed in the Project.\n\nThe intervention will be conducted at the premises of the Prevention Department in Ascoli Piceno and San Benedetto del Tronto, within the Local Health Authority of Ascoli Piceno (Marche Region, Italy), throughout 2026.\n\nEligible individuals will be invited, based on recruitment criteria, to the screening via a letter containing study information and participation instructions. Those willing to participate will book the appointment to undergo the screening in one of the two premises of the Prevention Department involved in the study (namely, San Benedetto del Tronto and Ascoli Piceno), through the regional reservation system (CUP). On the scheduled date, participants will visit the Prevention Department, where healthcare professionals (HCPs) will explain the study, obtain the informed consent, and collect data related to the CUORE and\u002For FINDRISC questionnaires, as well as sociodemographic information. The calculated scores will determine the 10-year risks of T2DM and major CVD events. Based on these risks, participants will be provided with tailored suggested pathways. A summary letter outlining these pathways will be delivered, and, in case of consent, results will be added to the participants' Electronic Health Record. Follow-up calls will be scheduled at 3 (T1) and 6 (T2) months to assess adherence to the suggested pathway (e.g., visit the General Practitioner (GP), lifestyle counselling) through a phone call.",[33,248],"Diabetes Mellitus Type 2",[250,251,252,248,33],"Diagnostic Screening Program","Delivering of healthcare, integrated","risk factors","2026-08-14",{"date":227,"type":41},{"date":256,"type":41},"2026-04-09",{"date":232,"type":22},{"name":259,"class":108},"Marche Region Regional Health Agency",2,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":269,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":272,"briefSummary":273,"conditions":274,"keywords":280,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":292},"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":271,"type":22},750,[91],"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.",[275,276,123,203,33,277,278,279],"Pulmonary Hypertension","Heart Failure With Reduced Ejection Fraction","Heart Failure","Heart Failure With Preserved Ejection Fraction","Heart Failure With Mid Range Ejection Fraction",[281,282,277,283,284],"Pulmonary Artery Denervation","Pulmonary Hypertension Due to Left Heart Disease","pulmonary hypertension","left heart failure",{"date":184,"type":41},{"date":287,"type":22},"2026-07-30",{"date":289,"type":22},"2031-12-31",{"name":291,"class":77},"Pulnovo Medical, Inc.",6,{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":301,"targetDuration":4,"studyType":23,"phases":303,"briefSummary":304,"conditions":305,"keywords":307,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":322},"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.",{"count":302,"type":22},780,[91],"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.",[33,306,277],"Heart Diseases",[277,308,309,310,311,312,313,314],"Left Ventricular Assist Device","Ventricular Dysfunction","Heart Disease","Cardiovascular Disease","Heart-assist Devices","Left Ventricular Assist System","BrioHealth Solutions",{"date":227,"type":41},{"date":317,"type":41},"2024-10-28",{"date":319,"type":22},"2028-12",{"name":321,"class":77},"BrioHealth Solutions, Inc.",47,{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":243,"enrollmentInfo":330,"targetDuration":4,"studyType":23,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":341,"locationsCount":49},"100454585","role-of-adiposomes-in-endothelial-dysfunction-100454585","NCT05199454","Role of Adiposomes in Endothelial Dysfunction","Role of Adiposomes in Diabetes-Associated Endothelial Dysfunction and Restorative Effects of Exercise and Metabolic Surgery","Inclusion Criteria:\n\n* BMI ≥ 35 kg\u002Fm2\n* Between ages 18-50 years\n* Not pregnant\n* Diabetic (Current use of diabetes medication or fasting glucose ≥126 mg\u002FdL)\n* Medical clearance to participate in a moderate-intensity exercise program\n\nExclusion Criteria:\n\n* Pregnant women\n* Current smokers\n* Currently abusing alcohol or drugs\n* Chronic heart, liver, or kidney diseases, autoimmune diseases, or cancer\n* Non-English speakers\n* History of allergic reactions to lidocaine",{"count":331,"type":22},60,[91],"The development of type II diabetes (T2D) is strongly associated with obesity and both are well-established risk factors for cardiovascular disease. Knowing that vascular dysfunction is an early event in the development of cardiovascular disease in obese diabetic (OB-T2D) patients, The investigators set their long-term goal to define molecular mechanisms of vascular dysfunction and corrective strategies that target these mechanisms such as physical activity and weight loss. The investigators recently discovered that human adipose tissues release extracellular vesicles (adiposomes) that are efficiently captured by endothelial cells. Adiposomes are known to carry bioactive cargos such as proteins and micro RNAs; however, their lipid content has not been studied nor has their ability to transfer their lipid cargo to endothelial cells. In the current application, the investigators propose to investigate the role of adiposomes in communicating the unhealthy milieu, mainly dysregulated lipids, to endothelial cells in OB-T2D subjects. On top of these lipid species that the investigators propose to be carried by adiposomes are glycosphingolipids (GSLs). These lipids originate from the glycosylation of ceramides, a chemical process that is upregulated in the presence of inflammation and high glucose levels. Preliminary findings showed that in endothelial cells, GSL-rich adiposomes disturb plasma membrane structure and subsequently induce endothelial dysfunction. Moreover, the investigators found that preconditioning endothelial cells with high shear stress (which is an exercise mimetic) protected endothelial cells from the detrimental effects induced by adiposomes. Therefore, the central hypothesis is that adipose tissues in OB-T2D patients release GSL-loaded adiposomes that induce vascular endothelial dysfunction. The researchers propose that exercise and weight loss interventions (bariatric surgery) will restore adipose tissue homeostasis, reduce GSL-loaded adiposomes, and subsequently alleviate vascular risk in OB-T2D patients. The investigators will test the hypotheses by pursuing the following aims: aim 1: Investigate the role of GSL-rich adiposomes in the pathogenesis of endothelial dysfunction in OB-T2D adults; aim 2: Test the effectiveness of exercise training in reducing adiposome-mediated effects on vascular function; and aim 3: Examine changes in adiposome\u002Fcaveolae axis following metabolic surgery and their association with vascular function.",[335,336,33],"Obesity","Diabetes",{"date":227,"type":41},{"date":339,"type":41},"2022-05-16",{"date":232,"type":22},{"name":342,"class":108},"University of Illinois at Chicago",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":140,"sex":17,"minAge":18,"maxAge":349,"enrollmentInfo":350,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":352,"conditions":353,"keywords":354,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":4,"leadSponsor":361,"locationsCount":49},"100054784","diabetes-and-heart-disease-risk-in-blacks-100054784","NCT00001853","Diabetes and Heart Disease Risk in Blacks","* IINCLUSION AND EXCLUSION CRITERIA\n\nCRITERIA FOR INCLUSION:\n\nEthnicity: Black\n\nThis is a study of adult African Americans and Blacks that were born in Africa but are now living in the United States. As African American people are multi-ethnic, we will in this initial investigation, study two different groups of African American. To enroll participants must self-identify as African Americans and be born in the United States, with American born parents or be born in Africa with African born parents. In both groups we will study sex differences in the role of obesity and TG levels on cardiovascular disease. In the future, we plan to expand the study to include other groups which self-identify as African Americans (i.e.AfroCarribeans and Hispanic blacks).\n\nOnly blacks are included in this study because the focus of this study is on gender differences in blacks in risk factors for CAD, specifically obesity, TG levels and TG related CAD risk factors. Unlike Caucasian women, premenopausal black women do not appear to be as protected from heart disease as a result of their gender. One model to study this apparent decrease in gender\n\nrelated cardioprotection in black women is to compare black men to black women. An alternative model would be to compare black women to Caucasian women. However, since the primary focus of this work is on gender differences rather than racial differences comparing black women to men is a superior model. Other racial groups do not share the loss of gender-related cardioprotection found in blacks, and have been excluded. Further the advantage of comparing black men and women is that this comparison provides a better control of dietary, cultural and genetic factors.\n\nAge: The age range of the participants will be between 18 and 70 years. As stated in the original protocol on page 14: Future investigations are planned which will involve similar comparisons between premenopausal and postmenopausal black women and between whites and blacks. To investigate risk for glucose intolerance, diabetes and cardiovascular risk factors, it is no longer sufficient to maintain the age range between 18 and 50 years. We need to expand to an age range with an increased prevalence of these risk factors.\n\nMedical History: To participate in the study subjects should identify themselves as healthy. This is important so the broadest possible sample of people will enroll. The fact that people are healthy will be confirmed by the history, physical and laboratory tests done as part of the screening visit. People with established coronary artery as evidenced by history of myocardial infarction, coronary artery bypass surgery or PTCA will be allowed to participate if they are not currently having angina.\n\nCRITERIA FOR EXCLUSION:\n\nBlack Ethnicity other than American or African.\n\nAs stated in the inclusion criteria black people are a multi-ethnic group. In this initial investigation we are focusing on African Americans who are American born and Africans living in the United States who are African born. In the future, we will expand the study to include other groups of blacks such as individuals of Afro-Caribbean and Hispanic blacks.\n\nMedications: People who take medications that are known to alter the parameters which are under investigation in this study will be excluded. People taking medications to treat hyperlipidemia will be included but analyses will be adjusted to take this into account. Subjects on thyroid hormone replacement will be included if their TSH is normal.\n\nDiabetes: Because diabetes affects insulin sensitivity and TG levels all people with diabetes even if the diabetes is controlled with diet alone will not be enrolled in the study.\n\nPregnant or Breastfeeding: Women who are pregnant, breastfeeding, or have an infant that is less than four months of age will be excluded. This is because the physiologic changes associated with pregnancy, breastfeeding or recent childbirth affect the parameters under study.\n\nMenstrual History: Now that postmenopausal women are included, menstrual history will be taken but women with irregular menses and hysterectomy will not be excluded. Women between the ages of 40 and 55 years will have FSH checked for proper characterization. Women 56 years of age and older will be assumed to be postmenopausal. However, women on any type of injectable hormonal contraception will be excluded because hormonal contraception affects both TG levels and glucose metabolism.","70 Years",{"count":351,"type":22},2000,"It is unknown if obesity contributes to the development of heart disease in African American men and women.\n\nThis study was created to determine whether there is a relationship between sex and body size and the incidence of heart disease in African American men and women. Researchers will attempt to associate obesity with the presence of heart disease risk factors. Risk factors that will be studied include; total body fat, body fat distribution, fat content of the blood (triglyceride concentration, low density lipoproteins \\[LDL\\], and high density lipoproteins \\[HDL\\]), how fast fat is removed from the blood, and how well insulin works in the body.\n\nScientific studies have shown that obesity and increased levels of fat content in the blood are important risk factors for heart disease in Caucasian women. However, similar studies in African American women have failed to show the same correlation. In fact, it appears that African American women in all three body weight groupings, nonobese, overweight, and obese experience high death rates due to heart disease. In addition, prior research has shown that obese African American men tend to have elevated levels of fat in the blood while African American women have normal blood fat levels. Therefore, if high levels of triglycerides (fat found in the blood) are not seen in non-diabetic obese African American women, it cannot be considered a risk factor in this population. This suggests that studies conducted on Caucasian women may not provide insight into heart disease risk factors in African American women.\n\nThe study will take 2000 healthy non-diabetic African American men and women (ages 18-70) and body mass index 3 subgroups; nonobese, overweight and obese. Diabetes undeniably increases the risk of heart disease. Therefore patients suffering from diabetes will not be included in the study. Candidates for the study will undergo a series of tests and examinations over 2 outpatient visits. Subjects will have body fat analyses, resting energy expenditure measurements, an EKG (electrocardiogram), and specific blood tests.\n\nResearchers believe this study will provide significant insight into the causes of obesity and heart disease in African Americans.",[33,336,335,123],[355,356,336,311,357],"Healthy Volunteers","Health Disparities","Natural History",{"date":227,"type":41},{"date":360,"type":41},"1998-10-21",{"name":362,"class":48},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)",{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":17,"minAge":370,"maxAge":4,"enrollmentInfo":371,"targetDuration":372,"studyType":200,"phases":4,"briefSummary":373,"conditions":374,"keywords":377,"overallStatus":388,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":49},"100652212","cardioprotective-effects-of-sglt2-inhibitors-and-glp-1-receptor-agonists-in-korean-patients-with-type-2-diabetes-100652212","NCT07770737","Cardioprotective Effects of SGLT2 Inhibitors and GLP-1 Receptor Agonists in Korean Patients With Type 2 Diabetes","Evaluation of Cardioprotective Effects of SGLT2 Inhibitors and GLP-1 Receptor Agonists in Korean Patients With Type 2 Diabetes: A Multicenter CDM-Based Retrospective Cohort Study With Prospective AI-ECG Validation","Phase 1: Retrospective Cohorts\n\nInclusion Criteria:\n\n* Adults aged 19 years or older.\n* Diagnosis of type 2 diabetes mellitus.\n* New initiation of a study medication, including an SGLT2 inhibitor, a GLP-1 receptor agonist, or another eligible glucose-lowering medication.\n* At least 180 days of observable data before the index date, defined as the date of the first eligible prescription.\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus or secondary diabetes mellitus.\n* Use of a medication from the same drug class within 90 days before the index date.\n* Pregnancy recorded during the relevant study period.\n* A history of the outcome being evaluated during the baseline period, applied separately for each outcome analysis.\n\nPhase 2: Prospective SGLT2 Inhibitor Validation Cohort\n\nInclusion Criteria:\n\n* Adults aged 50 years or older receiving outpatient care at Dongtan Sacred Heart Hospital.\n* Diagnosis of type 2 diabetes mellitus.\n* No current or previous signs or symptoms of heart failure and New York Heart Association functional class I.\n* At least one of the following high-risk characteristics: diabetes duration of 5 years or longer, hypertension, body mass index of 25 kg\u002Fm² or higher, urinary albumin-to-creatinine ratio of 30 mg\u002Fg or higher, estimated glomerular filtration rate below 60 mL\u002Fmin\u002F1.73 m², or diabetic microvascular complications.\n* No previous treatment with an SGLT2 inhibitor and scheduled to initiate an SGLT2 inhibitor based on the treating physician's clinical judgment.\n* Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Current or previous diagnosis of heart failure, hospitalization for heart failure, clinically suspected signs or symptoms of heart failure, or screening left ventricular ejection fraction below 50%.\n* Moderate or severe valvular heart disease, known hypertrophic, dilated, or infiltrative cardiomyopathy, complex congenital heart disease, or clinically significant pericardial disease.\n* Acute coronary syndrome, coronary revascularization, or stroke within 3 months before enrollment.\n* Presence of a pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device.\n* Atrial fibrillation, sustained tachycardia, frequent premature contractions, or another arrhythmia that prevents reliable comparison of ECG or global longitudinal strain measurements.\n* Type 1 diabetes mellitus, secondary diabetes mellitus, diabetic ketoacidosis within the previous year, or another clinical condition making SGLT2 inhibitor treatment inappropriate.\n* Estimated glomerular filtration rate below 30 mL\u002Fmin\u002F1.73 m² or dialysis.\n* Echocardiographic image quality insufficient for reliable 3-view global longitudinal strain or stage B heart failure assessment.\n* Pregnancy or breastfeeding.\n* Unwillingness to undergo study assessments or inability to complete the 6-month follow-up.","19 Years",{"count":220,"type":22},"6 Months","This observational study will evaluate the cardiovascular effects of sodium-glucose cotransporter-2 inhibitors (SGLT2 inhibitors) and glucagon-like peptide-1 receptor agonists (GLP-1 receptor agonists) in Korean adults with type 2 diabetes.\n\nThe study consists of two phases. Phase 1 will use de-identified electronic health record data from multiple Korean hospitals organized in a common data model. Cardiovascular outcomes, including myocardial infarction, ischemic stroke, and hospitalization for heart failure, will be compared among patients who started an SGLT2 inhibitor or a GLP-1 receptor agonist. Fractures, metabolic changes, and real-world medication use will also be evaluated.\n\nPhase 2 will prospectively enroll approximately 100 adults with type 2 diabetes who are starting an SGLT2 inhibitor as part of routine clinical care at Dongtan Sacred Heart Hospital. Participants will undergo electrocardiography, AI-based ECG analysis, echocardiography, blood and urine tests, and body composition assessment at baseline. Approximately 50 participants with stage B heart failure, defined as structural or functional heart abnormalities without heart failure symptoms, will undergo the same assessments after 6 months. The primary outcome of Phase 2 is the change in echocardiographic global longitudinal strain from baseline to 6 months. The study will also examine whether changes detected by AI-based ECG are associated with changes in echocardiographic measures of cardiac function.\n\nThe study does not assign medications or alter routine treatment. All treatment decisions are made by the participants' treating physicians.",[375,33,376],"Type 2 Diabetes Mellitus (T2DM)","Stage B Heart Failure",[378,379,380,381,382,383,384,376,385,386,387],"SGLT2 Inhibitor","GLP-1 Receptor Agonist","Cardiovascular Protection","Artificial Intelligence Electrocardiography","AI-ECG","Global Longitudinal Strain","Diabetic Cardiomyopathy","Pre-Heart Failure","OMOP Common Data Model","Real-World Data","NOT_YET_RECRUITING","2026-08-13",{"date":184,"type":41},{"date":392,"type":22},"2026-09",{"date":394,"type":22},"2027-12-31",{"name":396,"class":108},"Dongtan Sacred Heart Hospital",{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":17,"minAge":141,"maxAge":349,"enrollmentInfo":404,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":49},"100432563","targeted-health-dialogues-in-primary-care-100432563","NCT04912739","Targeted Health Dialogues in Primary Care","Targeted Health Dialogues in Primary Care: Lifestyle Screening and Molecular Profiling for a Healthier Life","Inclusion Criteria:\n\n* 40-, 50-, 60-, and 70-year old men and women\n* Listed at a healthcare center in Skåne county\n\nExclusion Criteria:\n\n\\* Inability to understand the written study information and give informed consent",{"count":405,"type":22},18000,"The County Council of Region Skåne, Sweden, has recently initiated Targeted Health Dialogues in primary care. The prevention program includes health dialogues provided by specially trained personnel, collection of clinical and laboratory data as well as questionnaire data on, e.g., individual health and health behaviors. So far, it enrolls all 40-year old Swedish and foreign-born inhabitants in the county and it will also include all 50- and 60-year old persons within a near future. A research project will be integrated within the program where the collected data will be linked, on the individual level, to national and regional data on hospital admissions, clinical diagnoses from specialist clinics and primary care, causes of death, and prescriptions. The individual linkages will also include population data on sociodemographic characteristics, neighborhood of residence and family relations. Blood samples will be collected for analyses of molecular biomarkers. The research project will examine associations between potential predictors and future risk of cardiovascular diseases and other serious diseases, such as cancer, and also whether the effect of the prevention program is modified by these potential predictors. The effect of the intervention will be examined, and whether the protocol needs to be modified in order to develop more precise and personalized medicine.",[408,409,33,410,411],"Health Behaviors","Risk Factors","Cancer","Serious Diseases","2026-08-12",{"date":389,"type":41},{"date":415,"type":41},"2020-10-01",{"date":417,"type":22},"2040-12-31",{"name":419,"class":108},"Region Skane",{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":427,"targetDuration":429,"studyType":200,"phases":4,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":440},"100612643","real-life-registry-in-patients-with-coronary-artery-disease-treated-with-the-selution-sirolimus-eluting-balloon-selution-iberia-registry-100612643","NCT07256249","Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry","SELUTION","Inclusion Criteria:\n\n* Patients with age ≥18 years and;\n* Patients with coronary artery disease in whom, at the operator's discretion, treatment of a lesion in a native vessel, coronary graft or coronary restenosis is decided using the Selution SLRTM device;\n* Patient who has been informed of the characteristics of the study and has provided written informed consent.\n\nExclusion Criteria:\n\n* Express refusal of the patient to participate in the study\n* Life expectancy of the patient of less than 12 months",{"count":428,"type":22},960,"12 Months","Selution Iberia registry is a post-market clinical follow-up, prospective, multicenter, international, longitudinal, observational study without a control group of consecutive unselected \"real-world\" patients with coronary artery disease in whom it was decided to use the SELUTION SLRTM device in the treatment of primary native lesions and ISR (in-stent restenosis) in all settings, in order to evaluate its effectiveness and safety.\n\nThe primary objective is to evaluate the effectiveness and safety of the Sirolimus-eluting balloon SELUTION SLRTM based strategy in the treatment of native coronary artery stenosis and in-stent restenosis. The primary endpoint will be the incidence of major adverse cardiovascular events at 12 months, including death, non-fatal myocardial infarction or target lesion revascularization for ischemia, in an unselected \"real-world\" patient setting. Both Device Oriented Composite Endpoint (Cardiovascular death, device failure-related myocardial infarction or device failure-related ischaemia) and Patient Oriented Composite Endpoint (all cause death, any stroke, any myocardial infarction or any revascularization) will be detailed.",[33],"2026-08-11",{"date":412,"type":41},{"date":435,"type":41},"2025-12-11",{"date":437,"type":22},"2027-01-01",{"name":439,"class":108},"Fundación EPIC",14,{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":447,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":449,"minAge":18,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":23,"phases":452,"briefSummary":453,"conditions":454,"keywords":458,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":260},"100608263","the-preeclampsia-postpartum-prevention-trial-100608263","NCT07199283","The PreEclampsia Postpartum Prevention Trial","The PEPP Trial: A Postpartum Bundle Intervention to Improve Cardiometabolic Health in Women After a First Pregnancy Affected by Preeclampsia - a Multi-centre Randomised Controlled Trial","PEPP","Inclusion Criteria\n\n* First-time mothers postpartum\n* Preeclampsia during first pregnancy\n* Age ≥ 18 years\n* Singleton live birth (infant still alive)\n* Ability to understand and speak Swedish, English\n* Having a smartphone (Android or iOS)\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Pre-pregnancy hypertension\n* Diabetes mellitus type I or II\n* Cardiovascular disease\n* Kidney disease\n* Systemic lupus erythematosus\n* Antiphospholipid syndrome\n* Previous or current eating disorders\n* Ongoing new pregnancy","FEMALE",{"count":451,"type":22},356,[91],"The goal of this clinical trial is to learn if a postpartum bundle intervention can improve cardiometabolic health and lifestyle-related factors in women who have had preeclampsia during their first pregnancy. The main questions it aims to answer are:\n\n* Does the 9-month intervention reduce systolic and diastolic blood pressure?\n* Does the intervention promote postpartum weight loss?\n* Does the intervention affect weight and blood pressure depending on early pregnancy BMI? Researchers will compare the bundle intervention to standard care to see if the intervention improves cardiometabolic health and lifestyle outcomes.\n\nAll participants will attend clinical visits for outcome assessments.\n\nParticipants in the intervention group will:\n\n* Receive online targeted screening and group meetings with study personnel\n* Use the trial-specific PEPP app to access self-monitoring tools for blood pressure and weight, lifestyle modification, and health education\n* Follow the intervention in two phases: starting after inclusion (≈8 weeks postpartum) with a Light phase (baseline-3 months) and progressing to an Intensive phase (3-9 months)",[455,456,123,33,457,335],"Preeclampsia","Postpartum Period","Overweight",[455,459,460,123,461],"Postpartum prevention","Prevention cardiometabolic disease","Postpartum weight loss",{"date":412,"type":41},{"date":464,"type":41},"2026-04-20",{"date":466,"type":22},"2028-04",{"name":468,"class":108},"Karolinska Institutet",{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":140,"sex":17,"minAge":477,"maxAge":478,"enrollmentInfo":479,"targetDuration":4,"studyType":23,"phases":481,"briefSummary":482,"conditions":483,"keywords":487,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":49},"100591501","cardiovascular-disease-prevention-strategies-for-high-risk-urban-sedentary-employees-in-karachi-pakistan-100591501","NCT06981247","Cardiovascular Disease Prevention Strategies for High-risk Urban Sedentary Employees in Karachi, Pakistan","m-Lifestyle Intervention for Employees (m-LIfE): Protocol for a Pilot Cluster Randomized Controlled Trial on Cardiovascular Disease Prevention Strategies","m-LIfE","Inclusion Criteria:\n\n• At least 6 months of job experience in any bank\n\nExclusion Criteria:\n\n* Diagnosed case of myocardial infarction, stroke, coronary heart disease, cerebrovascular disease, or peripheral arterial diseases\n* Pregnant women\n* Individuals with acute illnesses that limit physical activity","20 Years","65 Years",{"count":480,"type":22},84,[91],"Heart diseases and other non-communicable diseases are serious health issues in countries like Pakistan. Many people who work in offices, like bank employees, sit for more than 8 hours a day. This is called a sedentary lifestyle, and it increases the risk of heart diseases.\n\nThis research project aims to find out if a newly developed context specific mobile phone application can help these sedentary employees to improve their lifestyle. The app, called m-LIfE (mHealth-based Lifestyle Intervention for Employees), will be designed to help employees to move more during the day and eat healthier food like fruits and vegetables.\n\nThe study will involve bank employees in urban Karachi, Pakistan. They will be divided into two arms:\n\nIntervention arm: Participants in this arm will use the m-LIfE app for 12 weeks. They will get reminders and tips to take breaks, exercise, and eat healthy.\n\nRoutine care arm: Participants in this arm will receive printed basic educational material about prevention of risk factors of heart diseases and improving lifestyle.\n\nAfter the 12 weeks of intervention, there will be a follow-up period at 4th week to check if participants are maintaining healthy habits.\n\nThis study could help find simple and affordable ways to improve the health of office workers and reduce pressure on the healthcare system.",[484,485,486,33],"Physical Activity","Life Style","Dietary Habits",[488,489,490,491,492,493,494,495,496,497],"Primary care","Cardiology","Preventive medicine","risk perception","cardiovascular health","CVD","Sedentary lifestyle","mHealth","Digital health","Feasibility",{"date":412,"type":41},{"date":500,"type":41},"2026-06-22",{"date":502,"type":22},"2026-11",{"name":504,"class":108},"Aga Khan University",{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":511,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":49},"100474012","testing-virtues-patient-care-sets-in-cardiac-patients-virtues-cardiac-care-100474012","NCT05452356","Testing VIRTUES Patient Care Sets in Cardiac Patients (VIRTUES Cardiac Care)","Testing of Patient Care Sets and Management of Cardiovascular Conditions Using a Virtual Platform","VIRTUES-CC","Inclusion Criteria:\n\n* Any patient with a cardiovascular condition.\n* Ability to provide informed consent.\n* Proficient in the English language.\n* Access to a device capable of running mobile application.\n* Used mobile technology within the past 3 months.\n\nExclusion Criteria:\n\n* Any medical condition making 1-month survival unlikely.",{"count":351,"type":22},"Patients with various cardiac conditions (such as those who experience a heart attack) are increasing in Canada and are in need of appropriate cardiac rehabilitation and care. Many patients do not have access to local in-person cardiac clinics, particularly in rural regions of Canada. A user-friendly digital application with accessible educational resources and recommendations based on the most up to date clinical practice guidelines can help mitigate these issues. VIRTUES is a digital healthcare application that targets 11 modifiable modules as follows:\n\n1. antithrombotic management\n2. lipid management\n3. rate and rhythm control for atrial fibrillation\n4. heart failure care\n5. post myocardial infarction care\n6. blood sugar management\n7. blood pressure management\n8. physical activity\n9. healthy eating\n10. smoking cessation\n11. alcohol reduction\n\nOf the 11 total modules, the first 7 listed provide recommendations in VIRTUES. The remaining 4 (physical activity, healthy eating, smoking cessation and alcohol reduction) consist of simple referrals to existing recommendations (i.e., for healthy eating and physical exercise) and referrals to existing local programs (i.e., for smoking cessation and alcohol reduction). Thus, in this cohort study, the investigators will test the primary 7 modules with 200 patients per module for approximately one month each in order to obtain feedback on the usability of each module. The investigators will also conduct virtual focus group discussions to obtain open ended feedback on the application. This study will provide valuable feedback, which will be used to improve and adapt the VIRTUES platform.",[306,516,147,33,517],"Arrhythmias, Cardiac","Pathologic Processes",{"date":389,"type":41},{"date":520,"type":41},"2024-04-18",{"date":522,"type":22},"2028-09-30",{"name":524,"class":108},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":532,"targetDuration":534,"studyType":200,"phases":4,"briefSummary":535,"conditions":536,"keywords":537,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":49},"100651540","photon-counting-cardiac-ct-in-post-pci-patients-100651540","NCT07763340","Photon-Counting Cardiac CT in Post-PCI Patients","Diagnostic Performance and Prognostic Value of Multiparametric Photon-Counting Cardiac CT in Patients With Prior Coronary Stent Implantation: A Prospective Cohort Study","Inclusion Criteria:\n\n1. Age 18 years or older;\n2. History of percutaneous coronary intervention with implantation of at least one coronary stent;\n3. Ability to undergo iodinated contrast-enhanced CT;\n4. Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Estimated glomerular filtration rate below the institutional threshold for contrast-enhanced CT, generally less than 30 mL\u002Fmin\u002F1.73 m², unless examination is clinically justified and approved according to institutional policy;\n2. Known severe hypersensitivity to iodinated contrast material that cannot be adequately managed using the institutional premedication protocol; Pregnancy or suspected pregnancy;\n3. Inability to provide informed consent or comply with study procedures;\n4. Severe respiratory inability to perform the required breath-hold.",{"count":533,"type":22},800,"3 Years","This study takes patients who have undergone percutaneous coronary intervention as the research subjects and employs a prospective observational cohort design, aiming to develop and validate a \"one-stop\" photon-counting computed tomography imaging framework. The one-stop PCCT protocol implies that multiple assessments are acquired through a single examination, including coronary CT angiography for stent and native artery evaluation, resting first-pass myocardial iodine distribution imaging, and delayed myocardial extracellular volume quantification, with cardiac cine imaging performed in a prespecified dose-controlled substudy.",[33],[538,539,33],"Radiology","Photon-Counting CT","2026-08-10",{"date":389,"type":41},{"date":543,"type":41},"2026-01-07",{"date":545,"type":22},"2029-01-07",{"name":547,"class":108},"Chinese PLA General Hospital",{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":554,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":556,"targetDuration":198,"studyType":200,"phases":4,"briefSummary":557,"conditions":558,"keywords":559,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":566,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":573},"100538934","global-paradise-system-us-post-approval-study-100538934","NCT06297291","Global Paradise System US Post Approval Study","The Global Paradise® System US Post Approval Study (US GPS)","US GPS","Inclusion Criteria:\n\n* Signed and dated study informed consent\n* Documented history of hypertension\n* Documented history of prior or current antihypertensive medication(s)\n* Mean seated office systolic BP at screening ≥ 140 mmHg\n* Mean pre-procedure home systolic BP of ≥ 135 mmHg\n* Estimated glomerular filtration rate (eGFR) of ≥30 mL\u002Fmin\u002Fm2\n\nRADIANCE CAP patients must provide signed and dated informed consent for inclusion in long-term follow-up. No other criteria are required for inclusion.\n\nExclusion Criteria:\n\nPatients who meet the following will be excluded from participation:\n\n* Patient lacks appropriate renal anatomy for any treatment with the Paradise Catheter\n* Patient under the age of 18 years old at the time of consent\n* Patient is pregnant\n* Patients with transplanted kidney\n* Presence of abnormal kidney (or secreting adrenal) tumors\n\nTo confirm eligibility for treatment with the Paradise System, the following contraindications listed in the IFU may be determined at the time of procedure prior to treatment:\n\n* Renal arteries with diameter \\\u003C 3mm and \\> 8mm\n* Renal artery with fibromuscular dysplasia (FMD)\n* Stented renal artery\n* Renal artery aneurysm\n* Renal artery diameter stenosis \\>30%\n* Iliac\u002Ffemoral artery stenosis precluding insertion of the Paradise Catheter",{"count":143,"type":22},"The objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a catheter, cable, balloon, and generator and has received FDA approval in the United States. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment with the Paradise System for patients with high blood pressure.",[123,33,203],[560,561,562,563,564,565],"Blood Pressure","Uncontrolled Hypertension","Essential Hypertension","Resistant Hypertension","Renal Denervation","Ultrasound Renal Denervation",{"date":412,"type":41},{"date":568,"type":41},"2024-06-28",{"date":570,"type":22},"2031-07",{"name":572,"class":77},"ReCor Medical, Inc.",43,{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":4,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":269,"enrollmentInfo":581,"targetDuration":4,"studyType":23,"phases":583,"briefSummary":584,"conditions":585,"keywords":590,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":440},"100614975","a-prospective-multicenter-randomized-controlled-trial-to-investigate-the-value-of-coronary-ct-angiography-in-the-understanding-and-management-of-coronary-calcium-the-optimal-trial-100614975","NCT07286578","A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)","A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium","Inclusion Criteria:\n\n* The subject must be at least 18 years of age and younger than 85 years old\n* Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for PCI. Patients with a clinical indication for revascularization presenting with stable coronary artery disease or stabilized acute coronary syndrome defined as follows unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMI without high-risk features such as recurrence of chest pain, ST-segment depression\\>1mm in ≥6 leads plus STsegment elevation in aVR, life-threatening arrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE risk score\\>140.\n* All target vessels must have reference vessel diameter (visually assessed by CCTA) ≥ 2.5 mm\n* Subject must provide written informed consent before any study-related procedure\n\nExclusion Criteria:\n\n* STEMI as the clinical presentation.\n* Uncontrolled or recurrent ventricular tachycardia.\n* Hemodynamic instability.\n* Hemodialysis or peritoneal dialysis.\n* Left main coronary artery stenosis \\> 50%\n* Atrial fibrillation, flutter, or arrhythmias during CT acquisition.\n* Previous PCI in the target vessel or CABG.\n* BMI ≥ 40 kg\u002Fm2\n* Insufficient CT quality assessed by the Core lab.\n* Comorbidity with life expectancy ≤ 2 years.\n* Planned major cardiac or non-cardiac surgery within 24 months after the index procedure Note: Major surgery is any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. Note: Minor surgery is an operation on the superficial structures of the body or a manipulative procedure that does not involve a serious risk. Planned minor surgery is not excluded.\n* The subject has received a solid organ transplant that is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.\n* The subject receives immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.\n* The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest\u002Fmediastinum.\n* Subject has a platelet count \\\u003C100,000 cells\u002Fmm3 or \\>700,000 cells\u002Fmm3.\n* The subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.\n* The subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past six months. The subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc. The subject has a life expectancy \\\u003C2 years for any non-cardiac cause.\n* Subject is currently participating in another investigational drug or device clinical study.\n* Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.\n* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.\n* Unable to provide written informed consent (IC).",{"count":582,"type":22},700,[91],"The OPTIMAL randomized clinical trial has been designed to compare two imaging strategies and to test the hypothesis that a calcium modification strategy informed by coronary CT angiography (CCTA) will improve procedural efficiency and effectiveness compared with the current standard of care (IVUS-guided PCI) while achieving similar clinical outcomes in patients with hemodynamically significant calcified coronary artery disease.",[33,586,306,587,588,203,589],"Myocardial Ischemia","Arteriosclerosis","Arterial Occlusive Diseases","Coronary Artery Disease",[591,592],"IVUS","CT","2026-08-07",{"date":540,"type":41},{"date":596,"type":41},"2025-12-22",{"date":598,"type":22},"2030-01-01",{"name":439,"class":108},{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":23,"phases":610,"briefSummary":611,"conditions":612,"keywords":616,"overallStatus":388,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":632},"100648980","rapid-or-ultra-rapid-diagnosis-of-myocardial-infarction-using-high-sensitivity-cardiac-troponin-on-hospital-presentation-100648980","NCT07727135","Rapid or Ultra-rapid Diagnosis of Myocardial Infarction Using High-Sensitivity Cardiac Troponin on Hospital Presentation","Danish Randomized Trial of Rapid or Ultra-rapid Diagnosis of Myocardial Infarction Using High-Sensitivity Cardiac Troponin on Hospital Presentation","DanRUSH","Inclusion Criteria:\n\n* Adults (≥18 years) presenting with suspected acute coronary syndrome (ACS) with a clinical indication for high-sensitivity cardiac troponin testing\n\nExclusion Criteria:\n\n* Age \\\u003C18 years.\n* ST-segment elevation myocardial infarction (STEMI) identified on the presenting electrocardiogram and requiring immediate reperfusion therapy.",{"count":609,"type":22},28000,[91],"People with chest pain are often tested for a heart attack using a blood test called high-sensitivity cardiac troponin (hs-cTn). Traditionally, this blood test is repeated 3 hours after the first sample. Newer guidelines recommend repeating the test after 1 hour instead, which may allow patients to receive a diagnosis and leave the hospital sooner.\n\nThe purpose of the DanRUSH trial is to compare these two strategies: repeating the blood test after 1 hour versus after 3 hours in adults with suspected acute coronary syndrome. The study will evaluate whether the 1-hour strategy is as safe as the 3-hour strategy while reducing the length of hospital stay.\n\nDanRUSH is a nationwide, pragmatic, cluster-randomized trial conducted in emergency- and cardiology departments across Denmark. The results will help determine the best timing for blood testing in patients with suspected heart attack and improve future care for these patients.",[613,614,589,33,615],"Coronary Syndrome, Acute","Myocardial Infarction","Cardiovascular Disease Acute",[617,618,619,620,621,622],"Myocardial infarction","Troponin","Biomarker","Clinical assessment","Myocardial injury","Coronary syndrome","2026-08-04",{"date":625,"type":41},"2026-08-06",{"date":627,"type":22},"2026-09-01",{"date":629,"type":22},"2029-02-01",{"name":631,"class":108},"Herlev and Gentofte Hospital",11,{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":140,"sex":449,"minAge":58,"maxAge":349,"enrollmentInfo":639,"targetDuration":4,"studyType":23,"phases":641,"briefSummary":642,"conditions":643,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":646,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":49},"100552723","the-influence-of-chardonnay-marc-intake-on-gut-and-cardiometabolic-health-100552723","NCT06476795","The Influence of Chardonnay Marc Intake on Gut and Cardiometabolic Health","Inclusion Criteria:\n\n* Postmenopausal female, with a cessation of menses for at least 2 years\n* 45-70 years of age\n* BMI 25- 49.9 kg\u002Fm2\n* Fasting triglycerides \\> 120 mg\u002FdL\n* Subject is willing and able to comply with the study protocols and procedures.\n\nExclusion Criteria:\n\n* Self-reported use of daily anticoagulation agents including aspirin, NSAIDs\n* Prescription medications and supplements, except for a 6 month stable dose of thyroid medications\n* Vegan, Vegetarians, food faddists or those consuming a non-traditional diet\n* Fruit consumption ≥ 3 cups\u002Fday\n* Vegetable consumption ≥ 4 cups\u002Fday\n* Coffee\u002Ftea ≥ 3 cups\u002Fday\n* Dark chocolate ≥ 3 oz\u002Fday\n* Self-reported restriction of physical activity due to a chronic health condition\n* Self-reported chronic\u002Froutine high intensity exercise\n* Blood pressure ≥ 140\u002F90 mm Hg\n* Self-reported renal or liver disease\n* Self-reported heart disease, which includes cardiovascular events and stroke, diabetes\n* Peripheral artery disease Raynaud's syndrome or disease\n* Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT\n* Self-reported cancer within past 5 years\n* Self-reported gastrointestinal disorders, apart from appendix removal\n* Unwillingness to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements six weeks prior to study enrollment.\n* Indications of substance or alcohol abuse within the last 3 years\n* All forms of smoking (e.g. vaping, cigarette, cannabis)\n* Current enrollee in a clinical research study.",{"count":640,"type":22},5,[91],"Recently a dietary recommendation of 400 - 600 mg\u002F day has been proposed for the reduced risk of developing cardiovascular disease. Dietary flavanols can be obtained from the intake of foods such as tea, cocoa, wine, berries and apples. Incorporating Chardonnay Marc (the skins and seeds of Chardonnay grapes) into the diet can be an additional source of dietary flavanols. Like other flavanol-rich foods, Chardonnay Marc provides fiber and polysaccharides that may benefit gut health. This study seeks pilot data on the impact of the daily incorporation of Chardonnay Marc powder into the diet on markers of gut and cardiometabolic health.",[33,644,645],"Adiposity","Cardiometabolic Syndrome",{"date":593,"type":41},{"date":648,"type":41},"2024-06-01",{"date":650,"type":22},"2027-06",{"name":652,"class":108},"University of California, Davis",{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":659,"eligibilityCriteria":660,"healthyVolunteers":140,"sex":449,"minAge":58,"maxAge":661,"enrollmentInfo":662,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":664,"conditions":665,"keywords":669,"overallStatus":388,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":673,"startDateStruct":675,"completionDateStruct":677,"leadSponsor":679,"locationsCount":260},"100623239","a-prospective-multicenter-cohort-study-of-contemporary-menopausal-hormone-therapy-and-cardiovascular-outcomes-100623239","NCT07394049","A Prospective Multicenter Cohort Study of Contemporary Menopausal Hormone Therapy and Cardiovascular Outcomes","Cardiovascular Assesment Under Current Hormone Replacement Therapy in Menopause (CATCH-Menopause)","CATCH-Menopaus","Inclusion Criteria:\n\n* female sex\n* Age 45-75 years at enrollment\n* Perimenopausal or postmenopausal status documented according to prespecified clinical criteria\n* Increased cardiovascular risk, defined as SCORE \\> 5 % (age 45-69 years) or SCORE2-OP \\> 5 % (age \\> 70 years), or established disease\n* Established cardiovascular disease includes coronary artery disease, cerebrovascular disease and\u002For peripheral artery disease, as specified in the approved protocol\n* Ability to understand the study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C45 years or \\> 75 years\n* Active malignancy at screening\n* Inability to provide written informed consent or to comply with study procedures\n* Severe renal impairment, defined as estimated glomerular filtrate rate \\\u003C30 ml\u002Fmin\u002F1.73m2, or dialysis dependance\n* Advanced liver disease, defined as Child-Pugh class C\n* Known genetic cardiomyopathiy","75 Years",{"count":663,"type":22},3408,"This prospective registry study investigates the impact of new hormone replacement therapy (HRT) delivery methods, such as creams, gels, and sprays, on cardiovascular risk in postmenopausal women. Menopause-related estrogen deficiency leads to metabolic and vascular changes that increase atherosclerosis and cardiovascular events. This study hypothesizes that new HRT forms may reduce cardiovascular risk in high-risk women.\"",[666,33,667,668],"Hormone Replacement Therapy","Hormone Replacement Therapy, Post-Menopausal","Menopause",[670,671,672],"hormone replacement therapy","cardiovascular disease","menopause",{"date":674,"type":41},"2026-07-31",{"date":676,"type":22},"2026-08-01",{"date":678,"type":22},"2041-03",{"name":680,"class":108},"Heinrich-Heine University, Duesseldorf"]