Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
NCT06964464 · Heart Failure With Reduced Ejection Fraction (HFrEF), Sudden Cardiac Death, Ventricular Arrhythmia
RecruitingThis prospective, multicenter, open-label, randomized comparative effectiveness trial, titled CARVTOP-ICD, evaluates the impact of carvedilol versus metoprolol succinate in patients with heart failure with reduced ejection fraction (HFrEF) and an implantable cardioverter defibrillator (ICD). The study will enroll 2,000 participants across 100 U.S. sites and includes an 18-month feasibility phase with 100 participants from 15 sites. Eligible participants must be currently treated with metoprolol succinate and willing to switch to carvedilol, with randomization in a 1:1 ratio. Participants will be followed for up to 3 years, with regular assessments including ICD interrogations, medication adherence, healthcare utilization, and quality of life surveys. The primary endpoint is the first occurrence of any ICD therapy (appropriate or inappropriate), cardiovascular (CV) hospitalization, or CV death. Secondary endpoints include ICD shock burden, healthcare utilization, and patient-reported quality of life. The trial aims to provide high-quality comparative data to address clinical equipoise surrounding the two commonly used beta-blockers in HFrEF management.
PhasePhase 4
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 12 more
SponsorUniversity of Rochester
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation
NCT05636176 · Heart Failure
RecruitingThis study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAlexander City, Alabama, United States + 1116 more
SponsorNovo Nordisk A/S
▾Tap for detailsClick for full details — eligibility, all locations, contacts XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)
NCT06895070 · Heart Transplant, Heart Failure, Transplant; Failure, Heart
RecruitingThe purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation.
PhaseNA
TypeInterventional
Age18 Years
WhereLa Jolla, California, United States + 13 more
SponsorXVIVO Perfusion
▾Tap for detailsClick for full details — eligibility, all locations, contacts Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure
NCT07069738 · Heart Failure - NYHA II - IV
RecruitingThis study will compare two different methods to pace the heart to treat heart failure including: 1. The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left ventricle) to deliver heart failure therapy. This method is called Cardiac Resynchronization Therapy (CRT). 2. The other method is using a lead implanted in the Left Bundle Branch Area (LBBA) of your heart. This method is called Left Bundle Branch Area Pacing or LBBAP. This lead is approved by the Food and Drug Administration (FDA) to be implanted in this area of the heart, but not to provide heart failure treatment.
PhaseNA
TypeInterventional
Age18 Years
WhereHuntsville, Alabama, United States + 22 more
SponsorBoston Scientific Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts Assessment of CCM in HF With Higher Ejection Fraction
NCT05064709 · Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction
RecruitingThe AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.
PhaseNA
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 111 more
SponsorImpulse Dynamics
▾Tap for detailsClick for full details — eligibility, all locations, contacts Left vs Left Randomized Clinical Trial
NCT05650658 · Heart Failure, Heart Failure With Reduced Ejection Fraction, AV Block
RecruitingThe investigators aim to prospectively test the comparative effectiveness of His or Left bundle branch pacing in relation to patient centered outcomes (quality of life, physical activity, heart failure hospitalization, mortality) and comparative safety in relation to device-related complications and re-interventions (e.g., lead dislodgement, infection) relative to standard of care biventricular pacing in patients with heart failure due to left ventricular systolic dysfunction (LVEF≤50%) and with either a wide QRS (≥130 ms) or with/anticipated \>40% pacing who are already receiving current standard heart failure pharmacological therapy.
PhaseNA
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 70 more
SponsorBaylor College of Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction
NCT06736574 · Heart Failure, Heart Failure With Reduced Ejection Fraction
RecruitingThe purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction.
PhasePhase 3
TypeInterventional
Age18 Years – 85 Years
WhereAlexander City, Alabama, United States + 182 more
SponsorCytokinetics
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
NCT06424288 · Heart Failure
RecruitingThis study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.
PhasePhase 3
TypeInterventional
Age18 Years
WhereMobile, Alabama, United States + 652 more
SponsorBoehringer Ingelheim
▾Tap for detailsClick for full details — eligibility, all locations, contacts Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure
NCT06310031 · Cardiovascular Diseases, Heart Diseases, Heart Failure
RecruitingThe 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.
PhaseNA
TypeInterventional
Age18 Years – 100 Years
WhereLittle Rock, Arkansas, United States + 36 more
SponsorBrioHealth Solutions, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study
NCT04331769 · Heart Failure With Reduced Ejection Fraction (HFrEF), Dilated Cardiomyopathy
RecruitingProspective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).
PhaseNA
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 131 more
SponsorAncora Heart, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
NCT01790152 · Hodgkin Lymphoma in Remission, Leukemia in Remission, Lymphoblastic Lymphoma
RecruitingThis clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.
Phase—
TypeObservational
AgeAny
WhereBirmingham, Alabama, United States + 78 more
SponsorChildren's Oncology Group
▾Tap for detailsClick for full details — eligibility, all locations, contacts Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
NCT05677100 · Heart Failure, Cardiorenal Syndrome, Cardio-Renal Syndrome
RecruitingAortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and have persistent congestion despite usual medical therapy. Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management.
PhaseNA
TypeInterventional
Age21 Years
WherePhoenix, Arizona, United States + 47 more
SponsorProcyrion
▾Tap for detailsClick for full details — eligibility, all locations, contacts Non-interventional Study of Seroprevalence of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV9) and the Progression of Disease in Patients With Plakophilin 2 (PKP2)-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
NCT06311708 · Arrhythmogenic Right Ventricular Cardiomyopathy
RecruitingThis is a multicenter, non-interventional study to observe the natural progression of the disease and to study the prevalence of pre-existing antibodies to AAV9 used for gene therapy in a population of patients with PKP2 gene-associated ARVC. Participation from all patients is encouraged regardless of interest in or eligibility for gene therapy.
Phase—
TypeObservational
Age14 Years – 65 Years
WhereSan Francisco, California, United States + 20 more
SponsorTenaya Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
NCT06616974 · Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
RecruitingTX000045-003 is a double-blind, randomized, parallel group, placebo-controlled, proof- of-concept (POC) study, evaluating 2 dose regimens of TX000045 over the course of a 24-week treatment period (the APEX study).
PhasePhase 2
TypeInterventional
Age18 Years – 83 Years
WherePhoenix, Arizona, United States + 85 more
SponsorTectonic Therapeutic
▾Tap for detailsClick for full details — eligibility, all locations, contacts Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
NCT06526195 · Heart Failure, Heart Diseases, Cardiovascular Diseases
RecruitingThe purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.
PhaseNA
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 62 more
SponsorAbbott Medical Devices
▾Tap for detailsClick for full details — eligibility, all locations, contacts