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RecruitingPhase 2/Phase 3

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

Kardigan, Inc. · NCT07210723

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2, Phase 3
Target enrollment
332
US sites recruiting
27
Study start
February 13, 2026
Record last updated
October 5, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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

Being studied: danicamtiv; Placebo

Conditions: Symptomatic Genetic Dilated Cardiomyopathy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

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

  • Has heart failure with reduced ejection (HFrEF) caused primarily by ischemic heart disease, chronic valvulopathy, or another condition, as determined by the Investigator.
  • 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.
  • 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.
  • Unstable or untreated severe ventricular arrythmia (eg, ventricular tachycardia or ventricular fibrillation).
  • History of malignancy of any type within 5 years prior to Screening
  • 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]).
  • 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
  • History of heart transplantation or anticipated heart transplantation in the next 6 months.
  • 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
  • Clinically significant laboratory abnormalities at Screening

Recruiting US locations

  • University of Alabama Birmingham

    Birmingham, AL 35233

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • Cedars Sinai

    Los Angeles, CA 90048

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • University of California, San Diego (UCSD) - Medical Center

    San Diego, CA 92037

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • UCSF

    San Francisco, CA 94158

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • Stanford University Medical Center

    Stanford, CA 94305

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • MedStar Washington Hospital Center

    Washington D.C., DC 20010

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • Mayo Clinic - Jacksonville

    Jacksonville, FL 32224

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • Northwestern University

    Chicago, IL 60611

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • Louisiana State University (LSU) Health Sciences Center

    New Orleans, LA 70112

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • Johns Hopkins Medicine

    Baltimore, MD 21218

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • Brigham and Women's Hospital

    Boston, MA 02115

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • Henry Ford Health System

    Detroit, MI 48202

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • University of Minnesota

    Minneapolis, MN 55455

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • Mayo Clinic Rochester

    Rochester, MN 55905

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • Saint Luke's Mid America Heart Institute

    Kansas City, MO 64111

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • Washington University in St. Louis

    St Louis, MO 63110

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • University of Nebraska Medical Center

    Omaha, NE 68106

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • NYU Langone Health

    New York, NY 10016

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • Columbia University Medical Center/ New York Presbyterian Hospital

    New York, NY 10027

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • Duke University Medical Center

    Durham, NC 27708

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • The Lindner Center for Research and Education at The Christ Hospital

    Cincinnati, OH 45219

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • The Ohio State University Wexner Medical Center

    Columbus, OH 43210

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • Oregon Health & Science University (OHSU)

    Portland, OR 97239

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • Vanderbilt University Medical Center

    Nashville, TN 37232

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • Baylor College of Medicine

    Houston, TX 77030

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

  • Houston Methodist Hospital

    Houston, TX 77030

    Site contact: Kardigan Clinical Trial Team · 1-877-310-5135 · clinicaltrials@kardigan.bio

Study contacts (from the official record)

  • Kardigan Clinical Trial Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
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A Study of the Efficacy and Safety of Danicamtiv in Participants… (NCT07210723) | Bored Studies