Clinical trial Recruiting at 72 sites Phase2; Phase3 Interventional Ages 18 and up

Danicamtiv for people with symptomatic genetic or familial dilated cardiomyopathy

Official title: 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

Run by Kardigan, Inc. · NCT07210723 · Data updated 2026-11-12

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
Ages18 Years and up
SexAll
Enrollment332 (estimated)
SponsorKardigan, Inc.
Industry-sponsored
Locations79 sites (Birmingham, Alabama and 78 other locations)
StatusRecruiting
StartedFebruary 13, 2026
Main results expectedSeptember 2027
Study endsJanuary 2028
Registry record updatedNovember 4, 2026
Trial IDNCT07210723 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • University of Alabama Birmingham
    Birmingham, Alabama, United States
    Recruiting
  • Cedars Sinai
    Los Angeles, California, United States
    Recruiting
  • University of California, San Diego (UCSD) - Medical Center
    San Diego, California, United States
    Recruiting
  • UCSF
    San Francisco, California, United States
    Recruiting
  • Stanford University Medical Center
    Stanford, California, United States
    Recruiting
  • MedStar Washington Hospital Center
    Washington D.C., District of Columbia, United States
    Recruiting
Show 44 more locations
  • Mayo Clinic - Jacksonville
    Jacksonville, Florida, United States
    Recruiting
  • Northwestern University
    Chicago, Illinois, United States
    Recruiting
  • Louisiana State University (LSU) Health Sciences Center
    New Orleans, Louisiana, United States
    Recruiting
  • Johns Hopkins Medicine
    Baltimore, Maryland, United States
    Recruiting
  • Brigham and Women's Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Henry Ford Health System
    Detroit, Michigan, United States
    Recruiting
  • University of Minnesota
    Minneapolis, Minnesota, United States
    Recruiting
  • Mayo Clinic Rochester
    Rochester, Minnesota, United States
    Recruiting
  • Saint Luke's Mid America Heart Institute
    Kansas City, Missouri, United States
    Recruiting
  • Washington University in St. Louis
    St Louis, Missouri, United States
    Recruiting
  • University of Nebraska Medical Center
    Omaha, Nebraska, United States
    Recruiting
  • NYU Langone Health
    New York, New York, United States
    Recruiting
  • Columbia University Medical Center/ New York Presbyterian Hospital
    New York, New York, United States
    Recruiting
  • Duke University Medical Center
    Durham, North Carolina, United States
    Recruiting
  • The Lindner Center for Research and Education at The Christ Hospital
    Cincinnati, Ohio, United States
    Recruiting
  • The Ohio State University Wexner Medical Center
    Columbus, Ohio, United States
    Recruiting
  • Oregon Health & Science University (OHSU)
    Portland, Oregon, United States
    Recruiting
  • University of Pennsylvania
    Philadelphia, Pennsylvania, United States
    Recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee, United States
    Recruiting
  • Baylor College of Medicine
    Houston, Texas, United States
    Recruiting
  • Houston Methodist Hospital
    Houston, Texas, United States
    Recruiting
  • AZORG - Campus Moorselbaan
    Aalst, Belgium
    Recruiting
  • Universite Libre de Bruxelles (ULB) - Hopital Erasme
    Brussels, Belgium
    Recruiting
  • Universitair Ziekenhuis Antwerpen (UZA)
    Edegem, Belgium
    Recruiting
  • Jessa Ziekenhuis
    Hasselt, Belgium
    Recruiting
  • UZ Leuven
    Leuven, Belgium
    Recruiting
  • Aarhus University Hospital
    Aarhus, Denmark
    Recruiting
  • Rigshospitalet
    Copenhagen, Denmark
    Recruiting
  • Odense University Hospital - Odense
    Odense, Denmark
    Recruiting
  • CHRU de Tours - Hopital Trousseau
    Chambray-lès-Tours, France
    Recruiting
  • AP-HP Hopital Pitie-Salpetriere
    Paris, France
    Recruiting
  • AP-HP Hopital Europeen Georges Pompidou
    Paris, France
    Recruiting
  • CHU Rennes - Hopital Pontchaillou
    Rennes, France
    Recruiting
  • Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika
    Budapest, Hungary
    Recruiting
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
    Szeged, Hungary
    Recruiting
  • Azienda Ospedaliera Universitaria Consorziale - Policlinico Bari
    Bari, Italy
    Recruiting
  • Azienda Ospedaliero-Universitaria Careggi
    Florence, Italy
    Recruiting
  • Centro Cardiologico Monzino
    Milan, Italy
    Recruiting
  • ASST Grande Ospedale Metropolitano Niguarda
    Milan, Italy
    Recruiting
  • Istituto Clinico Humanitas
    Rozzano, Italy
    Recruiting
  • Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
    Trieste, Italy
    Recruiting
  • Amsterdam UMC - Locatie AMC
    Amsterdam, Netherlands
    Recruiting
  • Maastricht University Medical Center
    Maastricht, Netherlands
    Recruiting
  • Erasmus MC
    Rotterdam, Netherlands
    Recruiting

+29 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Danicamtiv for genetic or familial dilated cardiomyopathy

    This study tests whether danicamtiv, taken twice daily for up to five years, is safe and helps people with symptomatic genetic or familial dilated cardiomyopathy.

    Recruiting at 10 sites Phase 3 Kardigan, Inc. · Birmingham, Alabama and 77 other locations · NCT07771465

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 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.