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A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy

NCT07771465

Not Yet RecruitingPhase 3

Sponsor: Kardigan, Inc.

Conditions: Symptomatic Genetic Dilated Cardiomyopathy (DCM)

Interventions: Danicamtiv

Countries: United States, Belgium, Denmark, France, Hungary, Italy, Netherlands, Poland

Danicamtiv is an investigational medication, which means it is still being studied and has not been approved. The purpose of this study is to learn how well danicamtiv works, how safe it is, how well people can take it when used in patients with genetic or familial dilated cardiomyopathy (DCM). There are currently no approved medicines made specifically to treat genetic or familial DCM.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Completed 24 weeks of blinded study treatment (corresponding to the Week 26 Visit in DAN-301) and planned assessments in Part 1 or Part 2 of the DAN-301 study.
2. If sexually active, must use a highly effective birth control method from the Screening Visit through 3 months after the last dose.
3. Is able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent according to local and institutional guidelines before the first study-specific procedure.

Exclusion Criteria:

1. Acute coronary syndrome or hemodynamically significant epicardial coronary disease, or coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\]) performed within 90 days of DAN-302 Screening Visit.
2. Recent (\<90 days) hospitalization for heart failure (HF) or use of IV diuretic.
3. Other recent (\<90 days) cardiovascular events (e.g., cerebrovascular accident).
4. Hospitalization for sepsis or other systemic infections within 30 days of Screening. A systemic infection includes suspected or confirmed infection associated with fever, hemodynamic instability, bacteremia, or organ dysfunction typically requires urgent evaluation and/or acute care.
5. Any malignancy requiring treatment after enrollment in DAN-301 that could limit patient's survival.

Locations (78)

Birmingham, Alabama, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Diego, California, United States
San Francisco, California, United States
Stanford, California, United States
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
New York, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Houston, Texas, United States
Aalst, Belgium
Brussels, Belgium
+ 48 more on CT.gov