RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Kardigan, Inc. • ClinicalTrials.gov ID: NCT07771465

Registry updated: 2026-10-02

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Danicamtiv (Drug)
Danicamtiv will be administered twice daily for up to 5 years

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.

Conditions

Symptomatic Genetic Dilated Cardiomyopathy (DCM)

Locations

University of Alabama Birmingham — Birmingham, Alabama, United States
Cedars Sinai — Los Angeles, California, United States
University of California, Los Angeles (UCLA) - David Geffen School of Medicine — Los Angeles, California, United States
University of California, San Diego (UCSD) - Medical Center — San Diego, California, United States
University of California, San Francisco (UCSF) — San Francisco, California, United States
Stanford University Medical Center — Stanford, California, United States
MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
Northwestern University — Chicago, Illinois, United States
Louisiana State University (LSU) Health Sciences Center — New Orleans, Louisiana, United States
Johns Hopkins Medicine — Baltimore, Maryland, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
Henry Ford Health System — Detroit, Michigan, United States
University of Minnesota — Minneapolis, Minnesota, United States
Mayo Clinic - Rochester — Rochester, Minnesota, United States
Saint Luke's Mid America Heart Institute — Kansas City, Missouri, United States
Washington University in St. Louis — St Louis, Missouri, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
NYU Langone Health — New York, New York, United States
Columbia University Medical Center/ New York Presbyterian Hospital — New York, New York, United States
Duke University Medical Center — Durham, North Carolina, United States
The Lindner Center for Research and Education at The Christ Hospital — Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
Oregon Health & Science University (OHSU) — Portland, Oregon, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States
Baylor College of Medicine — Houston, Texas, United States
Houston Methodist Hospital — Houston, Texas, United States
AZORG - Campus Moorselbaan — Aalst, Belgium
Universite Libre de Bruxelles (ULB) - Hopital Erasme — Brussels, Belgium
Universitair Ziekenhuis Antwerpen (UZA) — Edegem, Belgium
Jessa Ziekenhuis — Hasselt, Belgium
UZ Leuven — Leuven, Belgium
Aarhus University Hospital — Aarhus, Denmark
Rigshospitalet — Copenhagen, Denmark
Odense University Hospital - Odense — Odense, Denmark
CHRU de Tours - Hopital Trousseau — Chambray-lès-Tours, France
CHU de Lille - Institut Coeur Poumon — Lille, France
AP-HP Hopital Pitie-Salpetriere — Paris, France
AP-HP Hopital Europeen Georges Pompidou — Paris, France
CHU Rennes - Hopital Pontchaillou — Rennes, France
Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika — Budapest, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont — Szeged, Hungary
Azienda Ospedaliera Universitaria Consorziale - Policlinico Bari — Bari, Italy
Azienda Ospedaliero-Universitaria Careggi — Florence, Italy
IRCCS Ospedale San Raffaele — Milan, Italy
Centro Cardiologico Monzino — Milan, Italy
ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy
Azienda Ospedale - Università Padova — Padova, Italy
Fondazione IRCCS Policlinico San Matteo — Pavia, Italy
Ospedale Policlinico Casilino — Roma, Italy
Istituto Clinico Humanitas — Rozzano, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara — Trieste, Italy
Amsterdam UMC - Locatie AMC — Amsterdam, Netherlands
Maastricht University Medical Center — Maastricht, Netherlands
Erasmus MC — Rotterdam, Netherlands
Uniwersyteckie Centrum Kliniczne, Gdansk — Gdansk, Poland
Krakowski Szpital Specjalistyczny im. sw. Jana Pawla II — Krakow, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi — Lodz, Poland
Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy w Warszawie — Warsaw, Poland
Hospital Universitario de A Coruña — A Coruña, Spain
Hospital Universitario Vall d'Hebron, Horta-Guinardó — Barcelona, Spain
Hospital Universitari de Bellvitge — Barcelona, Spain
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid 20222 — Madrid, Spain
Hospital Universitario Virgen de la Victoria — Málaga, Spain
Hospital Clinico Universitario Virgen de la Arrixaca — Murcia, Spain
Hospital Universitario Son Llatzer, Palma De Mallorca, — Palma de Mallorca, Spain
Hospital Universitario Virgen del Rocio — Seville, Spain
Sodersjukhuset AB — Stockholm, Sweden
Danderyds sjukhus — Stockholm, Sweden
University Hospitals Bristol NHS Foundation Trust — Bristol, United Kingdom
NHS Greater Glasgow and Clyde — Glasgow, United Kingdom
Glenfield hospital — Leicester, United Kingdom
St. Bartholomew's Hospital — London, United Kingdom
St George's Hospital — London, United Kingdom
Royal Brompton Hospital — London, United Kingdom
Hammersmith Hospital, Imperial College of London — London, United Kingdom
Cardiovascular Clinical Research Facility (CCRF) — Oxford, United Kingdom

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment