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
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 332 (estimated) |
| Sponsor | Kardigan, Inc. Industry-sponsored |
| Locations | 79 sites (Birmingham, Alabama and 78 other locations) |
| Status | Recruiting |
| Started | February 13, 2026 |
| Main results expected | September 2027 |
| Study ends | January 2028 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07210723 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
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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
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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
- Study coordinator: Kardigan Clinical Trial Information Team
- Email: clinicaltrials@kardigan.bio
- Phone: 1-877-310-5135
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.