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Clinical Trials in the USA / NCT07771465
Recruiting Phase 3

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

NCT07771465 · tracked via the Priya Life Science USA tracker
Sponsor
Kardigan, Inc.
Phase
Phase 3
Started
2026-08-26
Last updated
2026-09-02

Condition(s) studied

Symptomatic Genetic Dilated Cardiomyopathy (DCM)

Investigational drug(s) / intervention(s)

Danicamtiv

Danicamtiv: Danicamtiv will be administered twice daily for up to 5 years

Study summary

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (78)

FacilityCityRegionStatus
University of Alabama Birmingham Birmingham Alabama Recruiting
Cedars Sinai Los Angeles California Not Yet Recruiting
University of California, Los Angeles (UCLA) - David Geffen School of Medicine Los Angeles California Not Yet Recruiting
University of California, San Diego (UCSD) - Medical Center San Diego California Not Yet Recruiting
University of California, San Francisco (UCSF) San Francisco California Not Yet Recruiting
Stanford University Medical Center Stanford California Not Yet Recruiting
MedStar Washington Hospital Center Washington D.C. District of Columbia Not Yet Recruiting
Mayo Clinic - Jacksonville Jacksonville Florida Not Yet Recruiting
Northwestern University Chicago Illinois Not Yet Recruiting
Louisiana State University (LSU) Health Sciences Center New Orleans Louisiana Not Yet Recruiting
Johns Hopkins Medicine Baltimore Maryland Not Yet Recruiting
Brigham and Women's Hospital Boston Massachusetts Not Yet Recruiting
Henry Ford Health System Detroit Michigan Not Yet Recruiting
University of Minnesota Minneapolis Minnesota Not Yet Recruiting
Mayo Clinic - Rochester Rochester Minnesota Not Yet Recruiting
Saint Luke's Mid America Heart Institute Kansas City Missouri Not Yet Recruiting
Washington University in St. Louis St Louis Missouri Not Yet Recruiting
University of Nebraska Medical Center Omaha Nebraska Not Yet Recruiting
NYU Langone Health New York New York Not Yet Recruiting
Columbia University Medical Center/ New York Presbyterian Hospital New York New York Not Yet Recruiting
Duke University Medical Center Durham North Carolina Not Yet Recruiting
The Lindner Center for Research and Education at The Christ Hospital Cincinnati Ohio Not Yet Recruiting
The Ohio State University Wexner Medical Center Columbus Ohio Not Yet Recruiting
Oregon Health & Science University (OHSU) Portland Oregon Not Yet Recruiting
University of Pennsylvania Philadelphia Pennsylvania Not Yet Recruiting
Vanderbilt University Medical Center Nashville Tennessee Not Yet Recruiting
Baylor College of Medicine Houston Texas Not Yet Recruiting
Houston Methodist Hospital Houston Texas Not Yet Recruiting
AZORG - Campus Moorselbaan Aalst Belgium Not Yet Recruiting
Universite Libre de Bruxelles (ULB) - Hopital Erasme Brussels Belgium Not Yet Recruiting
Universitair Ziekenhuis Antwerpen (UZA) Edegem Belgium Not Yet Recruiting
Jessa Ziekenhuis Hasselt Belgium Not Yet Recruiting
UZ Leuven Leuven Belgium Not Yet Recruiting
Aarhus University Hospital Aarhus Denmark Not Yet Recruiting
Rigshospitalet Copenhagen Denmark Not Yet Recruiting
Odense University Hospital - Odense Odense Denmark Not Yet Recruiting
CHRU de Tours - Hopital Trousseau Chambray-lès-Tours France Not Yet Recruiting
CHU de Lille - Institut Coeur Poumon Lille France Not Yet Recruiting
AP-HP Hopital Pitie-Salpetriere Paris France Not Yet Recruiting
AP-HP Hopital Europeen Georges Pompidou Paris France Not Yet Recruiting

+ 38 more sites — see the full list on the official registry below.

More Kardigan, Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07771465 on ClinicalTrials.gov ↗ ← All trials in the USA