Status:
RECRUITING
A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Lead Sponsor:
Kardigan, Inc.
Conditions:
Symptomatic Genetic Dilated Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT07210723
Start Date
January 1 2026
End Date
January 1 2028
Last Update
January 5 2026
Active Locations (7)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35233
2
UCSF
San Francisco, California, United States, 94158
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905