Find Dilated Cardiomyopathy (DCM) Clinical Trials Near You
A Phase 2b/3, Adaptive, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Status: Recruiting
Location: See all (43) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The Sponsor is studying an investigational medication called danicamtiv to determine if it can help people with genetic and familial dilated cardiomyopathy (DCM). Investigational means that the safety and effectiveness of danicamtiv have not been established. Currently, there are no approved drugs that are designed specifically to treat genetic or familial DCM. The purpose of this study is to evaluate how well danicamtiv works compared to a placebo (sugar pill that looks like danicamtiv pill but does not contain any danicamtiv) and see how safe it is for people with genetic and familial DCM. In DCM, the heart muscle weakens and enlarges, making it harder for the heart to pump blood; this can happen for different reasons. Some people have DCM because of a change in a gene (called genetic DCM). Others may have DCM that runs in their family, even if no specific gene change is found (called familial DCM). The main goals of the study are: * To assess the effect of danicamtiv on cardiac function using echocardiogram. * To evaluate the impact of danicamtiv on exercise capacity * To evaluate the safety and tolerability of danicamtiv Participants will: * Take danicamtiv or placebo every day for approximately 6 months * Visit the clinic about 12 times for initial evaluation, checkups, tests and follow up
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Has a diagnosis of DCM due to probable disease-causing variants of MYH7, TTN, or other identified genetic DCM variants, or with familial DCM
• Has New York Heart Association (NYHA) Class II-IV at Screening with stable symptoms for ≥1 month.
• Has at least mild left ventricular enlargement (LVE) and has adequate acoustic windows to enable accurate TTEs according to the Echocardiography Core Laboratory.
• Has a LVEF of ≤45%.
• Is on stable doses of maximally tolerated standard-of-care heart failure (HF) therapies reflecting current guidelines for at least 4 weeks prior to the first visit.
• Has DCM not attributed to substance abuse, amyloidosis, sarcoidosis, or any other secondary form of cardiomyopathy per the Investigator.
• Can perform an upright cardiopulmonary exercise training (CPET) with a peak oxygen uptake (pV̇O2) of 80% or less of predicted for a healthy individual and respiratory exchange ratio (RER) of ≥1.05
Locations
United States
Alabama
University of Alabama Birmingham
RECRUITING
Birmingham
California
Cedars Sinai
RECRUITING
Los Angeles
University of California, San Diego (UCSD) - Medical Center
RECRUITING
San Diego
UCSF
RECRUITING
San Francisco
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
Mayo Clinic - Jacksonville
RECRUITING
Jacksonville
Illinois
Northwestern University
RECRUITING
Chicago
Louisiana
Louisiana State University (LSU) Health Sciences Center
RECRUITING
New Orleans
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Michigan
Henry Ford Health System
RECRUITING
Detroit
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Missouri
Washington University in St. Louis
RECRUITING
St Louis
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
New York
Columbia University Medical Center/ New York Presbyterian Hospital
NOT_YET_RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Ohio
The Ohio State University Wexner Medical Center
RECRUITING
Columbus
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Texas
Baylor College of Medicine
RECRUITING
Houston
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Rigshospitalet
RECRUITING
Copenhagen
Odense University Hospital - Odense
RECRUITING
Odense
France
AP-HP Hopital Pitie-Salpetriere
RECRUITING
Paris
Hungary
Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika
RECRUITING
Budapest
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont