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Danicamtiv for people with symptomatic genetic or familial dilated cardiomyopathy

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

Phase2; Phase3 Interventional Kardigan, Inc. · NCT07210723

This trial will test whether the oral drug danicamtiv can improve heart function and symptoms in adults with symptomatic genetic or familial dilated cardiomyopathy.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment332 (estimated)
Ages18 Years and up
SexAll
SponsorKardigan, Inc. Industry-sponsored
Locations33 sites (Birmingham, Alabama and 32 other locations)
Trial IDNCT07210723 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled Phase 2/3 trial compares danicamtiv to placebo in adults with symptomatic genetic or familial dilated cardiomyopathy who remain symptomatic on standard heart failure therapy. Participants must have reduced left ventricular ejection fraction (≤45%), specified genetic findings or a family history, and be able to perform cardiopulmonary exercise testing; cardiac imaging (echocardiography) and exercise measures are used to track effects. The study monitors safety and tolerability alongside measures of cardiac function, symptoms, and exercise capacity over the treatment period. Enrollment occurs at several U.S. academic centers with centralized imaging review.

Who should consider this trial

Good fit: Adults with symptomatic genetic or familial dilated cardiomyopathy (for example with disease-causing MYH7 or TTN variants or a family history), NYHA class II–IV, LVEF ≤45%, on stable guideline-directed heart failure therapy, and able to complete cardiopulmonary exercise testing are ideal candidates.

Not a fit: People whose cardiomyopathy is due to secondary causes such as amyloidosis, sarcoidosis, substance abuse, those without a genetic or familial pattern, those with LVEF >45%, or who cannot perform exercise testing are unlikely to qualify or benefit from this trial.

Why it matters

Potential benefit: If successful, danicamtiv could improve heart pumping function, reduce symptoms, and increase exercise capacity for people with genetic or familial DCM.

How similar studies have performed: Related cardiac myosin activators (for example omecamtiv mecarbil) have shown some positive effects on heart function and outcomes in heart failure studies but results were mixed, and using this approach specifically for genetic/familial DCM is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Has a diagnosis of DCM due to probable disease-causing variants of MYH7, TTN, or other identified genetic DCM variants, or with familial DCM
2. Has New York Heart Association (NYHA) Class II-IV at Screening with stable symptoms for ≥1 month.
3. Has at least mild left ventricular enlargement (LVE) and has adequate acoustic windows to enable accurate TTEs according to the Echocardiography Core Laboratory.
4. Has a LVEF of ≤45%.
5. 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.
6. Has DCM not attributed to substance abuse, amyloidosis, sarcoidosis, or any other secondary form of cardiomyopathy per the Investigator.
7. 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

Key Exclusion Criteria:

1. Has heart failure with reduced ejection (HFrEF) caused primarily by ischemic heart disease, chronic valvulopathy, or another condition, as determined by the Investigator.
2. Recent (\<90 days) clinically significant cardiac events, including acute coronary syndrome, hemodynamically significant epicardial coronary disease (per Investigator), coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\]), or hospitalization for heart failure/intravenous (IV) diuretic use.
3. Presence of disqualifying cardiac rhythms that might interfere with reliable echocardiographic measurements of left ventricle (LV) function, as determined by the Investigator including: (a) inadequately rate-controlled atrial fibrillation, (b) ectopic beats (atrial, junctional or ventricular) of sufficient frequency (e.g. \> 10% of total beats) that the participant's cardiac rhythm is irregular potentially interfering with reliable echocardiographic measurements of LV function.
4. Unstable or untreated severe ventricular arrythmia (eg, ventricular tachycardia or ventricular fibrillation).
5. History of malignancy of any type within 5 years prior to Screening
6. Severe renal insufficiency (defined at the time of Screening as current estimated glomerular filtration rate \[eGFR\] \<15 mL/min/1.73m2 by simplified Modification of Diet in Renal Disease equation \[sMDRD\]).
7. History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Sponsor, would pose a risk to participant safety or interfere with the study evaluation
8. History of heart transplantation or anticipated heart transplantation in the next 6 months.
9. Ongoing or anticipated advanced cardiac interventions, including chronic IV inotropic therapy, planned cardiac resynchronization therapy (CRT) or major surgery, or current/anticipated ventricular assist device placement within 6 months
10. Clinically significant laboratory abnormalities at Screening

Where this trial is running

Birmingham, Alabama and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Symptomatic Genetic Dilated Cardiomyopathy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.