Actively Recruiting
A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Led by Kardigan, Inc. · Updated on 2026-04-28
332
Participants Needed
33
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with dilated cardiomyopathy (DCM) caused by certain genetic variants or familial DCM
- New York Heart Association (NYHA) Class II-IV symptoms with stable condition for at least 1 month
- Mild left ventricular enlargement with adequate ultrasound imaging quality
- Left ventricular ejection fraction (LVEF) of 45% or less
- On stable doses of standard heart failure treatments for at least 4 weeks before starting
- DCM not caused by substance abuse, amyloidosis, sarcoidosis, or other secondary cardiomyopathies
- Able to perform upright cardiopulmonary exercise testing with peak oxygen uptake at or below 80% of predicted and respiratory exchange ratio of 1.05 or higher
You will not qualify if you...
- Heart failure caused mainly by ischemic heart disease, valvular disease, or other primary conditions
- Recent serious heart events in the past 90 days, including heart attacks, coronary procedures, or heart failure hospitalizations
- Cardiac rhythms that interfere with accurate heart function measurements, such as poorly controlled atrial fibrillation or frequent abnormal beats
- Unstable or untreated severe ventricular arrhythmias
- History of cancer within 5 years before screening
- Severe kidney failure (estimated glomerular filtration rate less than 15 mL/min/1.73m2)
- Other serious health conditions that could risk safety or interfere with study results
- History of or planned heart transplantation within 6 months
- Planned or ongoing advanced heart treatments like intravenous inotropes, cardiac resynchronization therapy, major surgery, or ventricular assist devices
- Significant abnormal laboratory test results at screening
AI-Screening
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Trial Site Locations
Total: 33 locations
1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Cedars Sinai
Los Angeles, California, United States, 90048
Actively Recruiting
3
UCSF
San Francisco, California, United States, 94158
Actively Recruiting
4
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
5
Louisiana State University (LSU) Health Sciences Center
New Orleans, Louisiana, United States, 70112
Actively Recruiting
6
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
7
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
8
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
10
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68106
Actively Recruiting
11
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
12
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
13
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
14
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
15
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
16
Rigshospitalet
Copenhagen, Denmark, 1050
Actively Recruiting
17
AP-HP Hopital Pitie-Salpetriere
Paris, France, 75013
Actively Recruiting
18
Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika
Budapest, Hungary, 1122
Actively Recruiting
19
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Hungary, 6724
Actively Recruiting
20
Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
Trieste, Italy, 34100
Actively Recruiting
21
Hospital Universitario Vall d'Hebron
Horta-Guinardó, Barcelona, Spain, 08035
Actively Recruiting
22
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 20222
Actively Recruiting
23
Hospital Universitario de A Coruña
A Coruña, Spain, 15006
Actively Recruiting
24
Hospital Universitari de Bellvitge
Barcelona, Spain, 08907
Actively Recruiting
25
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, Spain, 30120 El Palmar,
Actively Recruiting
26
Hospital Universitario Son Llatzer
Palma de Mallorca, Spain, 7198
Actively Recruiting
27
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
28
Sodersjukhuset AB
Stockholm, Sweden, 11883
Actively Recruiting
29
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
30
St. Bartholomew's Hospital
London, United Kingdom, EC1A
Actively Recruiting
31
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Actively Recruiting
32
Hammersmith Hospital, Imperial College of London
London, United Kingdom, W12 0HS
Actively Recruiting
33
Cardiovascular Clinical Research Facility (CCRF)
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
Research Team
K
Kardigan Clinical Trial Information Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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