[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Baim Institute for Clinical Research\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":98},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100658878","phase-2-this-will-be-a-randomized-comparison-of-the-proteomic-effects-of-vicadrostatempagliflozin-versus-empagliflozin-and-versus-empagliflozinspironolactone-in-heart-failure-patients-with-preserved-ejection-fraction-100658878",false,"NCT07857772","This Will be a Randomized Comparison of the Proteomic Effects of Vicadrostat\u002FEmpagliflozin Versus Empagliflozin and Versus Empagliflozin\u002FSpironolactone in Heart Failure Patients With Preserved Ejection Fraction","A Randomized Comparison of the Proteomic Effects of Vicadrostat\u002FEmpagliflozin Versus Empagliflozin and Versus Empagliflozin\u002FSpironolactone in Heart Failure Patients With Preserved Ejection Fraction","SPECTRA-HFpEF","Inclusion Criteria:\n\n1. Participant is aged ≥18 years.\n2. Participant provides informed consent to participate in the study in accordance with ICH-GCP and local legislation prior to any study procedures taking place.\n3. Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of \\\u003C1% per year when used consistently and correctly.\n4. Participant has chronic HF diagnosed ≥3 months before enrollment, and in New York Heart Association (NYHA) class II-IV.\n5. Participant has LVEF \\>40% in the 12 months prior to enrollment.\n6. N-terminal pro-B type natriuretic peptide (NT-proBNP) must be:\n\n   NT-proBNP level (kg\u002Fm²) BMI \\\u003C27 (kg\u002Fm²) BMI ≥27 to \\\u003C35 BMI ≥35 Without AF or AFL Non-Black participants ≥300 pg\u002FmL ≥200 pg\u002FmL ≥125 pg\u002FmL Black Participants ≥240 pg\u002FmL ≥160 pg\u002FmL ≥100 pg\u002FmL With AF or AFL Non-Black participants ≥600 pg\u002FmL ≥400 pg\u002FmL ≥250 pg\u002FmL Black Participants ≥480 pg\u002FmL ≥320 pg\u002FmL ≥200 pg\u002FmL Abbreviations: AF: atrial fibrillation; AFL: atrial flutter. Note: Race is self-reported.\n7. Participants must have ≥1 of the following:\n\n   1. Currently treated with diuretic therapy (e.g. loop diuretics or thiazides) and on a stable dose for ≥1 week prior to enrollment.\n   2. Currently treated with an SGLT2 inhibitor and on a stable dose for at ≥1 week prior to enrollment; those receiving an SGLT2 inhibitor for treatment of diabetes mellitus will be monitored for need of extra glucose lowering treatment by the study investigator in conjunction with the local physician during the washout period per usual care.\n   3. Documented hospitalization for HF within 6 months prior to enrollment.\n   4. Elevated cardiac filling pressures (e.g. pulmonary capillary wedge pressure ≥15 mm at rest or ≥25 mm with exercise) within 6 months prior to enrollment.\n   5. Markedly elevated NT-proBNP\n\n      * In participants without AF\u002FAFL: ≥900 pg\u002FmL\n      * In participants with AF\u002FAFL: ≥1800 pg\u002FmL\n   6. UACR ≥30 mg\u002Fg.\n   7. At least 2 echocardiographic cardiac structural changes from the following:\n\n      * Left ventricular hypertrophy\n      * E\u002Fe' ≥9\n      * Left atrial volume index \\>33 mL\u002Fm2\n\nExclusion Criteria:\n\n1. Treatment with an MRA (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to enrollment and no intention to initiate MRA during the study.\n2. Treatment with amiloride, direct renin inhibitor (e.g. aliskiren), or the combination of ACEi plus ARB.\n3. Treatment with any other ASi.\n4. Major contraindication to SGLT2 inhibition, including history of Type 1 diabetes or previous ketoacidosis.\n5. eGFR \\\u003C 20 mL\u002Fmin\u002F1.73m2 at screening.\n6. Serum potassium \\>5.2 mmol\u002FL at screening.\n7. Myocardial infarction, cerebrovascular accident, transient ischemic attack, stroke, coronary artery bypass graft (CABG) surgery, heart valve surgery or any other major surgery (per investigator judgement) within 90 days prior to enrollment, or scheduled for major elective surgery (e.g. hip replacement, CABG surgery).\n8. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device.\n9. Known cardiomyopathy due to infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy, or known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to enrollment.\n10. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding enrollment.\n11. Known severe valvular heart disease (obstructive or regurgitant), per investigator judgment, or valvular heart disease scheduled for surgical or invasive procedures at enrollment, or anticipated invasive treatment during the study.\n12. Active or prior cancer of any kind except for non-melanoma skin cancers.\n13. Psychiatric illness, cognitive impairment, behavioral issues, or social situation that in the opinion of the investigator will compromise the participant's ability to comply with study procedures\n14. Participant is pregnant or lactating or plans to become pregnant during the study or up to 2 weeks after the study.\n15. Patient has a known hypersensitivity to any components of the IMPs or any of their excipients that, in the opinion of the investigator, suggests a high risk for a severe hypersensitivity reaction while on treatment.\n16. Any other condition not specified above that in the opinion of the investigator would confound the interpretation of data from the study\n\n    \\-","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The SPECTRA-HFpEF Study is a randomized, double-blind, Phase 2 clinical study designed to evaluate and compare the biological effects of vicadrostat in combination with empagliflozin, empagliflozin alone, and spironolactone in combination with empagliflozin in adults with heart failure and preserved ejection fraction. The study will enroll approximately 200 participants with chronic heart failure, New York Heart Association Class II to IV symptoms, and left ventricular ejection fraction greater than 40%. The primary objective is to determine whether treatment with vicadrostat\u002Fempagliflozin produces differential changes in circulating plasma proteins compared with spironolactone\u002Fempagliflozin, using a broad proteomic panel measured over the course of treatment. These proteomic changes may help identify biological pathways affected by each treatment strategy, including pathways related to inflammation, myocardial fibrosis and remodeling, kidney function, cardiac stress, and aldosterone-related signaling.\n\nParticipants will complete an approximately 26-week study period, including screening, treatment, and follow-up phases. After screening and any required washout of prior sodium-glucose cotransporter 2 inhibitor therapy, participants will receive open-label empagliflozin and will be randomized in a blinded manner to receive vicadrostat or placebo during the first treatment period. During the second treatment period, participants will receive either continued vicadrostat with empagliflozin or spironolactone with empagliflozin. During the third treatment period, vicadrostat or spironolactone will be discontinued while empagliflozin is continued. Blood and urine samples will be collected at specified visits to evaluate changes in proteomic markers, renin-angiotensin-aldosterone system biomarkers, collagen turnover markers, sex hormone markers, kidney function, proteinuria, inflammatory biomarkers, and cardiac stress biomarkers. Echocardiography and patient-reported health status assessments will also be performed to explore potential effects on cardiac structure, function, symptoms, and quality of life.\n\nThe study is intended to improve understanding of how aldosterone synthase inhibition with vicadrostat differs from mineralocorticoid receptor antagonism with spironolactone when each is used with empagliflozin in patients with heart failure and preserved ejection fraction. By comparing treatment-related proteomic and biomarker changes across study arms, the study may provide insight into mechanistic differences between these therapeutic approaches and help inform future development of targeted combination therapies for heart failure. Safety and tolerability will be monitored throughout the study through collection of adverse events, serious adverse events, vital signs, electrocardiograms, physical examinations, and clinical laboratory assessments, including kidney function and serum potassium monitoring.",[27],"Heart Failure With Preserved Ejection Fraction (HFPEF)",[29],"Heart Failure","NOT_YET_RECRUITING","2026-09-29",{"date":33,"type":34},"2026-10-05","ACTUAL",{"date":36,"type":21},"2027-03",{"date":38,"type":21},"2028-09",{"name":40,"class":41},"Baim Institute for Clinical Research","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100658287","clinical-evidence-with-biomarker-confirmation-for-ppmi-in-pci-clinical-trials-study-100658287","NCT07848529","Clinical Evidence With Biomarker Confirmation for PPMI in PCI Clinical Trials Study","CEC-PPMI","Inclusion Criteria:\n\n1. Subject age is ≥ 18 years or minimum legal age as required by local regulations.\n2. Documented stable angina or functional testing demonstrating ischemia; or stabilized non-ST elevation acute coronary syndrome defined as negative or confirmed declining site determined biomarker.\n3. Subject is eligible for dual anti-platelet therapy treatment with aspirin plus either, clopidogrel, prasugrel, or ticagrelor.\n4. Life expectancy \\>1 year in opinion of investigator.\n5. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.\n\nExclusion Criteria:\n\n1. ST elevation myocardial infarction within 7 days\n2. Non-ST elevation myocardial infarction without stable or declining biomarkers.\n3. Previous percutaneous coronary intervention within 7 days.\n4. Inability to comply with recommended duration of dual anti-platelet therapy.\n5. Decompensated heart failure.",{"count":50,"type":21},1000,"OBSERVATIONAL","The goal of this prospective, multicenter, non-randomized observational study is to better identify and understand periprocedural myocardial injury among adults undergoing percutaneous coronary intervention (PCI) for stable coronary artery disease or stabilized non-ST-elevation acute coronary syndrome. The main questions it aims to answer are:\n\n* Can a clinical criteria checklist identify patients with an increased likelihood of cardiac biomarker elevation following PCI?\n* Are positive clinical criteria and different post-PCI levels of troponin I, troponin T, and CK-MB associated with all-cause mortality or hospitalization for heart failure at one year? Researchers will compare participants with a positive clinical criteria checklist with those with a negative checklist to assess differences in post-PCI biomarker elevations and one-year clinical outcomes. Outcomes will also be compared between participants discharged on the same day and those hospitalized overnight.\n\nParticipants will:\n\n* Undergo PCI using commercially approved devices according to local standards of care.\n* Have blood samples collected before and after PCI to measure cardiac biomarkers.\n* Have relevant clinical and PCI procedural information collected, including completion of a clinical criteria checklist by the study team before discharge.\n* Be followed for one year to determine whether they have died from any cause or been hospitalized for heart failure.",[54,55,56,57,58],"Peri-procedural Myocardial Infarction","Heart Failure Hospitalization","Mortality","Stable Angina Pectoris","Non ST Elevation Myocardial Infarction (NSTEMI)",[60,61,62],"PCI","Coronary artery disease","biomarkers","2026-09-23",{"date":65,"type":34},"2026-09-30",{"date":67,"type":21},"2026-12",{"date":69,"type":21},"2029-12",{"name":40,"class":41},1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":95,"leadSponsor":97,"locationsCount":4},"100655487","phase-4-heart-kidney-diabetes-multidisciplinary-care-models-for-cardiovascular-health-in-patients-with-chronic-kidney-disease-and-diabetes-a-pragmatic-cluster-randomized-controlled-trial-holistic-100655487","NCT07811427","Heart-Kidney-Diabetes Multidisciplinary Care MOdels for CardiovascuLar Health In Patients With Chronic Kidney DiSease and Diabetes: A PragmaTIC Cluster Randomized Controlled Trial (HOLISTIC)","HOLISTIC","Inclusion Criteria:\n\n1. Provide written informed consent\n2. Adults ≥18 years of age with T2D and CKD at high or very high KDIGO risk (Figure A1): eGFR 45-59 mL\u002Fmin\u002F1.73 m2 and UACR \\>300 mg\u002Fg OR eGFR 30-44 mL\u002Fmin\u002F1.73 m2 and UACR \\>30 mg\u002Fg OR any eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2.\n\nExclusion Criteria:\n\n1. Advanced HF on inotrope support or requiring left ventricular assist device support.\n2. Chronic hemodialysis or peritoneal dialysis or kidney transplant\n3. Life expectancy of \\\u003C1-year, and vulnerable populations such as pregnant women, incarcerated individuals, or those with active psychiatric illness.\n4. Unreliable or non-compliant, including patients with known history of alcoholism, drug abuse, or serious psychiatric disorder; as well as patients unwilling to abide by the requirements of the protocol\n5. Any condition that would interfere with the patient's ability to comply with study instructions, might confound the interpretation of the study, or put the patient at risk\n6. Personnel, or any relative of personnel, of the Sponsor, the CRO, or the investigative site(s)",{"count":80,"type":21},570,[82],"PHASE4","Our overarching goal of this study is to provide rigorous evidence for using an accelerated risk-based approach to implementing guideline directed medical therapies (GDMT) using a multidisciplinary care model (MCM) versus a usual care model (UCM) to improve a composite GDMT score, reduce kidney disease and heart failure (HF) events, hospitalizations, and total healthcare costs for patients with type 2 diabetes (T2D) and CKD with high- to very-high Kidney Disease: Improving Global Outcomes (KDIGO) risk.",[85,86],"Chronic Kidney Disease","Type II Diabetes",[88,89,90],"Cardiovascular-kidney-metabolic","Multidisciplinary Care Model","Guideline Directed Medical Therapies","2026-09-03",{"date":93,"type":34},"2026-09-10",{"date":67,"type":21},{"date":96,"type":21},"2029-05",{"name":40,"class":41},""]