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

RecruitingPhase 3

An Open-label Extension Study to Assess the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy

Who can join

Ages 18 and older · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Kardigan, Inc. · Participants: 332 · Started: Aug 26, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07771465

Locations in the U.S.

AlabamaUniversity of Alabama Birmingham, Birmingham
CaliforniaCedars Sinai, Los Angeles (Not yet recruiting)
University of California, Los Angeles (UCLA) - David Geffen School of Medicine, Los Angeles (Not yet recruiting)
University of California, San Diego (UCSD) - Medical Center, San Diego (Not yet recruiting)
University of California, San Francisco (UCSF), San Francisco (Not yet recruiting)
Stanford University Medical Center, Stanford (Not yet recruiting)
District of ColumbiaMedStar Washington Hospital Center, Washington D.C. (Not yet recruiting)
FloridaMayo Clinic - Jacksonville, Jacksonville (Not yet recruiting)
IllinoisNorthwestern University, Chicago (Not yet recruiting)
LouisianaLouisiana State University (LSU) Health Sciences Center, New Orleans (Not yet recruiting)
MarylandJohns Hopkins Medicine, Baltimore (Not yet recruiting)
MassachusettsBrigham and Women's Hospital, Boston (Not yet recruiting)
MichiganHenry Ford Health System, Detroit (Not yet recruiting)
MinnesotaUniversity of Minnesota, Minneapolis (Not yet recruiting)
Mayo Clinic - Rochester, Rochester (Not yet recruiting)
MissouriSaint Luke's Mid America Heart Institute, Kansas City (Not yet recruiting)
Washington University in St. Louis, St Louis (Not yet recruiting)
NebraskaUniversity of Nebraska Medical Center, Omaha (Not yet recruiting)
New YorkColumbia University Medical Center/ New York Presbyterian Hospital, New York (Not yet recruiting)
NYU Langone Health, New York (Not yet recruiting)
North CarolinaDuke University Medical Center, Durham (Not yet recruiting)
OhioThe Lindner Center for Research and Education at The Christ Hospital, Cincinnati (Not yet recruiting)
The Ohio State University Wexner Medical Center, Columbus (Not yet recruiting)
OregonOregon Health & Science University (OHSU), Portland (Not yet recruiting)
PennsylvaniaUniversity of Pennsylvania, Philadelphia (Not yet recruiting)
TennesseeVanderbilt University Medical Center, Nashville (Not yet recruiting)
TexasBaylor College of Medicine, Houston (Not yet recruiting)
Houston Methodist Hospital, Houston (Not yet recruiting)

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.