What is danicamtiv studying for genetic and familial dilated cardiomyopathy?

Danicamtiv is being studied to evaluate its effects on heart function and exercise capacity in people with genetic and familial dilated cardiomyopathy. The study compares danicamtiv with a placebo and is sponsored by Kardigan, Inc. It aims to understand how well danicamtiv works and how safe it is for this condition.

Who may be eligible for this genetic and familial dilated cardiomyopathy clinical trial?

Adults aged 18 years and older with a diagnosis of genetic or familial dilated cardiomyopathy may be eligible. Participants should have stable heart failure symptoms classified as NYHA Class II-IV, a left ventricular ejection fraction of 45% or less, and be on stable heart failure treatment doses for at least 4 weeks. Please review eligibility criteria for more details.

Is there any cost to participate in this genetic and familial dilated cardiomyopathy clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years +

All Genders

ID07210723

Study of Danicamtiv for Treating Symptomatic Genetic and Familial Dilated Cardiomyopathy A Phase 2b3 Randomized, Double-Blind, Placebo-Controlled Trial

Led by Kardigan, Inc. · Updated on 2026-08-04

332

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying an investigational drug called danicamtiv to see if it can help people with genetic and familial dilated cardiomyopathy DCM, conditions where the heart muscle weakens and enlarges, making it harder for the heart to pump blood. This study aims to compare danicamtiv to a placebo to evaluate its effects and safety in people with these types of DCM, as there are currently no approved drugs specifically for genetic or familial DCM. Participants will take either danicamtiv or a placebo twice daily for about 6 months. The study includes two groups one receiving danicamtiv and the other receiving a placebo, both administered for up to 26 weeks. The goal is to assess changes in heart function using echocardiograms and exercise capacity, as well as to monitor safety and tolerability. Throughout the study, participants will visit the clinic approximately 12 times for initial evaluations, checkups, tests, and follow-up appointments. Researchers will measure heart function changes, exercise capacity, and safety outcomes using echocardiograms, exercise tests, questionnaires, and blood tests. The main outcomes include changes in heart function and exercise capacity over 26 weeks, with continuous safety monitoring during the study period.

CONDITIONS

Brief Title

A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosis of dilated cardiomyopathy (DCM) due to probable disease-causing genetic variants or familial DCM
New York Heart Association (NYHA) Class II-IV symptoms stable for at least 1 month
At least mild left ventricular enlargement with adequate echocardiogram imaging quality
Left ventricular ejection fraction (LVEF) of 45% or less
On stable doses of maximally tolerated standard heart failure treatments for at least 4 weeks
DCM not caused by substance abuse, amyloidosis, sarcoidosis, or other secondary cardiomyopathies
Ability to perform upright cardiopulmonary exercise test with peak oxygen uptake (pVO2) of 80% or less of predicted and respiratory exchange ratio (RER) of 1.05 or higher

You will not qualify if you...

Heart failure caused primarily by ischemic heart disease, chronic valvulopathy, or other conditions
Recent (within 90 days) significant cardiac events such as acute coronary syndrome or coronary interventions
Cardiac rhythms that interfere with echocardiographic measurement, including poorly controlled atrial fibrillation or frequent ectopic beats
Unstable or untreated severe ventricular arrhythmia
History of any cancer within 5 years before screening
Severe kidney failure with estimated glomerular filtration rate (eGFR) below 15 mL/min/1.73m2
Other significant disorders posing risks or interfering with the study
History or planned heart transplantation within 6 months
Ongoing or planned advanced cardiac interventions including chronic IV inotropic therapy, cardiac resynchronization therapy, major surgery, or ventricular assist device placement within 6 months
Clinically significant abnormal lab results at screening

Research Team

Kardigan Clinical Trial Information Team

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Study of Danicamtiv for Treating Symptomatic Genetic and Familial Dilated Cardiomyopathy A Phase 2b3 Randomized, Double-Blind, Placebo-Controlled Trial

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria