Advanced Heart Failure Program Clinical Trials

Danon Disease Natural History Study
Start Date: December 2023
Completion Date: August 2026 (estimated)
Recruitment Status: accepting new patients
Keywords: Danon Disease, LAMP2, Lysosome-associated membrane protein 2, Cardiomyopathy, X-linked, Glycogen Storage Disease Type IIb, Prospective

A Gene Therapy Study of RP-A501 in Male Patients With Danon Disease
Start Date: September 2023
Completion Date: September 2029 (estimated)
Recruitment Status: not accepting new patients
Keywords: Danon Disease, Hypertrophic Cardiomyopathy, HCM, X-linked disease, LAMP2, Pediatric, Skeletal Myopathies, Cardiomyopathy, Lysosomal Storage Disorder, Left Ventricular Hypertrophy, Glycogen Storage Disease Type IIb

Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM (ACACIA-HCM)
Start Date: August 2023
Completion Date: September 2026 (estimated)
Keywords/Conditions: Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

Multi-center, Open-label, Single-ascending Dose Study of Safety and Tolerability of TN-201 in Adults With Symptomatic MYBPC3 Mutation-associated HCM
Start Date: August 2023
Completion Date: August 2032 (estimated)
Recruitment Status: accepting new patients
Keywords: Hypertrophic Cardiomyopathy, Hypertrophic Cardiomyopathy (HCM), Myosin Binding Protein C3 (MYBPC3), Nonobstructive HCM, Genetic HCM, Familial HCM, Adenoassociated Virus (AAV), Gene Therapy, Cardiomyopathies, Hypertrophy

A Phase 1, Dose Escalation Trial of RP-A601 in Subjects With PKP2 Variant-Mediated Arrhythmogenic Cardiomyopathy (PKP2-ACM)
Start Date: August 2023
Completion Date: September 2026 (estimated)
Recruitment Status: accepting new patients
Keywords: PKP2 Arrhythmogenic Cardiomyopathy (PKP2-ACM), Arrhythmogenic cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Sudden Cardiac Death, Genetic cardiomyopathy, Gene therapy, PKP2, ARVC, ARVD, ACM, Cardiac Arrest, Ventricular Arrythmia, Cardiomyopathies

A Phase 3, Multi-center, Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy
Start Date: June 2023
Completion Date: October 2025 (estimated)
Recruitment Status: not accepting new patients
Keywords: Obstructive Hypertrophic Cardiomyopathy, Aficamten, Metoprolol, oHCM, CK-3773274, CK-274, MAPLE-HCM, MAPLE, CY 6032, Cardiomyopathies, Cardiomyopathy, Hypertrophic, Hypertrophy, Heart Diseases, Cardiovascular Diseases, Pathological Conditions, Anatomical, Aortic Stenosis, Subvalvular, Aortic Valve Stenosis, Aortic Valve Disease, Heart Valve Diseases, Metoprolol, Anti-Arrhythmia Agents

A Study to Evaluate the Efficacy, Safety, and Tolerability of MYK-224 in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Start Date: January 2023
Completion Date: August 2026 (estimated)
Recruitment Status: Not recruiting
Keywords: Cardiomyopathy, Hypertrophic

A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy
Start Date: December 2022
Completion Date: March 2025 (estimated)
Keywords: Cardiomyopathy, Hypertrophic

Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
Start Date: July 2022
Completion Date: December 2028 (estimated)
Recruitment Status: recruiting
Keywords: Peripartum Cardiomyopathy, Postpartum, Cardiomyopathies, Bromocriptine, Rivaroxaban, Guideline Directed Medical Therapy for Heart Failure (GDMT)

MYTHS - Myocarditis Therapy With Steroids
Start Date: October 2021
Completion Date: December 2028 (estimated)
Recruitment Status: recruiting
Keywords: Myocarditis Acute, Acute Myocarditis, Corticosteroid therapy, Myocarditis, Trial, Immunosuppression, Acute heart failure, Fulminant acute myocarditis, Methylprednisolone, Methylprednisolone Acetate, Methylprednisolone Hemisuccinate, Prednisolone, Prednisolone acetate, Prednisolone hemisuccinate, Prednisolone phosphate, saline solution

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
Start Date: December 2020
Completion Date: December 2030 (estimated)
Recruitment Status: accepting new patients
Keywords: Heart Failure with Reduced Ejection Fraction (HFrEF), Dilated Cardiomyopathy, Heart Failure, Reduced Ejection Fraction, Cardiomyopathy, Cardiomyopathies, AccuCinch Ventricular Restoration System, Guideline-Directed Medical Therapy

Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients
Start Date: April 2020
Completion Date: March 2023 (estimated)
Recruitment Status: in progress, not accepting new patients
Keywords: Acute Respiratory Distress Syndrome, Cardiac Failure, Extracorporeal Membrane Oxygenation Complication, Respiratory Failure, Renal Failure, Critical Illness, Pulmonary Disease, ECMO, ARDS, Ventilator induced Lung Injury, Heart Failure, Pulmonary Failure, Biomarkers, Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Respiratory Insufficiency, Acute Lung Injury, Ventilator, Low Driving Pressure Protocol

CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
Start Date: March 2020
Completion Date: August 2026 (estimated)
Recruitment Status: in progress, not accepting new patients
Keywords: Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM), TTR, Amyloidosis, Cardiomyopathy, Cardiomyopathies, Eplontersen

PROACTIVE-HF IDE Trial Heart Failure NYHA Class III
Start Date: January 2020
Completion Date: April 2028 (estimated)
Recruitment Status: in progress, not accepting new patients
Keywords: Heart Failure NYHA Class III, Heart Failure, Heart Disease, Cardiovascular Disease, Pulmonary Artery Pressure, Cordella™ Pulmonary Artery Sensor System

Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy
Start Date: September 2019
Completion Date: December 2025 (estimated)
Recruitment Status: in progress, not accepting new patients
Keywords: Diabetic Cardiomyopathies, Type 2 Diabetes, Aldose Reductase Inhibitor, Stage B Heart Failure, Stage C Heart Failure, Cardiopulmonary Exercise Test, Cardiomyopathies

Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure
Start Date: September 2019
Completion Date: September 2030 (estimated)
Recruitment Status: accepting new patients
Keywords: Cardiotoxicity, Pediatric Cancer, Heart Failure, Cardiac magnetic resonance imaging (MRI), Echocardiography, Electrocardiogram

Gene Therapy for Male Patients With Danon Disease (DD) Using RP-A501; AAV9.LAMP2B
Start Date: April 2019
Completion Date: March 2025 (estimated)
Recruitment Status: in progress, not accepting new patients
Keywords: Danon Disease, hypertrophic cardiomyopathy, HCM, X-linked disease, LAMP 2A, Pediatric, Skeletal myopathies, Glycogen Storage Disease Type IIb

Allograft Dysfunction in Heart Transplant
Start Date: October 2019
Completion Date: December 2025 (estimated)
Recruitment Status: accepting new patients
Keywords: Heart Transplant Failure and Rejection, heart transplant, acute graft rejection, chronic graft rejection, Regadenoson, Nonspecific allograft dysfunction, Cardiac allograft vasculopathy, ACR/AMR

Tocilizumab in Cardiac Transplantation
Start Date: December 2018
Completion Date: April 2025 (estimated)
Recruitment Status: Not currently recruiting at UCSD
Keywords: Heart Transplant, heart transplant recipients, alloimmunity, anti-inflammatory, tocilizumab, efficacy clinical trial, immunosuppression (IS), Mycophenolic Acid, Prednisone, Methylprednisolone, Tacrolimus, Calcineurin Inhibitors

Surveillance HeartCare® Outcomes Registry
Start Date: December 2018
Completion Date: November 2026 (estimated)
Recruitment Status: in progress, not accepting new patients
Keywords: Heart Transplant Rejection, HeartCare

Destination Therapy Post Approval Study
Start Date: October 2018
Completion Date: April 2026 (estimated)
Recruitment Status: in progress, not accepting new patients
Keywords: Chronic Heart Failure, Heart Failure, Heart Diseases, Cardiovascular Diseases, HeartWare Ventricular Assist Device

Early Feasibility Study - Edwards APTURE Transcatheter Shunt System
Start Date: July 2018
Completion Date: November 2028 (estimated)
Recruitment Status: accepting new patients at some sites, but this study is not currently recruiting here
Keywords: Heart Failure, Transcatheter Atrial Shunt System, Edwards Transcatheter Atrial Shunt System

Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients
Start Date: January 2018
Completion Date: June 2025 (estimated)
Recruitment Status: in progress, not accepting new patients
Keywords: Heart Failure, WiSE System

Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With Advanced Heart Failure (TAVR UNLOAD)
Start Date: September 2016
Completion Date: February 2025 (estimated)
Recruitment Status: in progress, not accepting new patients
Keywords: Aortic Valve Stenosis, Valve, Heart Failure, SAPIEN 3 THV, Optimal Heart Failure Therapy, OHFT