Can a new drug strengthen hearts weakened by genetic disease?

NCT ID NCT07771465

Disease control Sponsor: Kardigan, Inc. Source: ClinicalTrials.gov ↗

First seen Aug 18, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This study tests the long-term safety and effectiveness of an investigational drug called danicamtiv in adults with symptomatic genetic or familial dilated cardiomyopathy (DCM), a condition where the heart muscle weakens and enlarges. Participants who completed a prior 24-week study will receive danicamtiv twice daily for up to 5 years. The goal is to see if the drug can improve heart function and reduce disease-related events, while monitoring for side effects. There are currently no approved medicines specifically for this type of DCM.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: danicamtiv
What this could lead to: If successful, danicamtiv could become the first approved treatment specifically for genetic or familial dilated cardiomyopathy, potentially improving heart function and quality of life.
What could go wrong: This is an extension study, so it builds on earlier data but still may not prove long-term benefit. Side effects and tolerability over up to 5 years are unknown, and the drug is not yet approved.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 332 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Jan 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

dilated cardiomyopathy familial dilated cardiomyopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Symptomatic genetic dilated cardiomyopathy (DCM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

78 sites in 11 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AP-HP Hopital Europeen Georges Pompidou
NOT_YET_RECRUITING

Paris, 75015, France
AP-HP Hopital Pitie-Salpetriere
NOT_YET_RECRUITING

Paris, 75013, France
ASST Grande Ospedale Metropolitano Niguarda
NOT_YET_RECRUITING

Milan, 20162, Italy
AZORG - Campus Moorselbaan
NOT_YET_RECRUITING

Aalst, 9300, Belgium
Aarhus University Hospital
NOT_YET_RECRUITING

Aarhus, 8200, Denmark
Amsterdam UMC - Locatie AMC
NOT_YET_RECRUITING

Amsterdam, 1105-AZ, Netherlands
Azienda Ospedale - Università Padova
NOT_YET_RECRUITING

Padova, 35128, Italy
Azienda Ospedaliera Universitaria Consorziale - Policlinico Bari
NOT_YET_RECRUITING

Bari, 70124, Italy
Azienda Ospedaliero-Universitaria Careggi
NOT_YET_RECRUITING

Florence, 50314, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
NOT_YET_RECRUITING

Trieste, 34100, Italy
Baylor College of Medicine
NOT_YET_RECRUITING

Houston, Texas, 77030, United States
Brigham and Women's Hospital
NOT_YET_RECRUITING

Boston, Massachusetts, 02115, United States
CHRU de Tours - Hopital Trousseau
NOT_YET_RECRUITING

Chambray-lès-Tours, 37170, France
CHU Rennes - Hopital Pontchaillou
NOT_YET_RECRUITING

Rennes, 35033, France
CHU de Lille - Institut Coeur Poumon
NOT_YET_RECRUITING

Lille, 59037, France
Cardiovascular Clinical Research Facility (CCRF)
NOT_YET_RECRUITING

Oxford, OX3 9DU, United Kingdom
Cedars Sinai
NOT_YET_RECRUITING

Los Angeles, California, 90048, United States
Centro Cardiologico Monzino
NOT_YET_RECRUITING

Milan, 20138, Italy
Columbia University Medical Center/ New York Presbyterian Hospital
NOT_YET_RECRUITING

New York, New York, 10027, United States
Danderyds sjukhus
NOT_YET_RECRUITING

Stockholm, 182 88, Sweden
Duke University Medical Center
NOT_YET_RECRUITING

Durham, North Carolina, 27708, United States
Erasmus MC
NOT_YET_RECRUITING

Rotterdam, 3015 GD, Netherlands
Fondazione IRCCS Policlinico San Matteo
NOT_YET_RECRUITING

Pavia, 27100, Italy
Glenfield hospital
NOT_YET_RECRUITING

Leicester, LE3 9QP, United Kingdom
Hammersmith Hospital, Imperial College of London
NOT_YET_RECRUITING

London, W12 0HS, United Kingdom
Henry Ford Health System
NOT_YET_RECRUITING

Detroit, Michigan, 48202, United States
Hospital Clinico Universitario Virgen de la Arrixaca
NOT_YET_RECRUITING

Murcia, 30120, Spain
Hospital Universitari de Bellvitge
NOT_YET_RECRUITING

Barcelona, 08907, Spain
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid 20222
NOT_YET_RECRUITING

Madrid, 20222, Spain
Hospital Universitario Son Llatzer, Palma De Mallorca,
NOT_YET_RECRUITING

Palma de Mallorca, 7198, Spain
Hospital Universitario Vall d'Hebron, Horta-Guinardó
NOT_YET_RECRUITING

Barcelona, 08035, Spain
Hospital Universitario Virgen de la Victoria
NOT_YET_RECRUITING

Málaga, 29001, Spain
Hospital Universitario Virgen del Rocio
NOT_YET_RECRUITING

Seville, 41013, Spain
Hospital Universitario de A Coruña
NOT_YET_RECRUITING

A Coruña, 15006, Spain
Houston Methodist Hospital
NOT_YET_RECRUITING

Houston, Texas, 77030, United States
IRCCS Ospedale San Raffaele
NOT_YET_RECRUITING

Milan, 20132, Italy
Istituto Clinico Humanitas
NOT_YET_RECRUITING

Rozzano, 20089, Italy
Jessa Ziekenhuis
NOT_YET_RECRUITING

Hasselt, 3500, Belgium
Johns Hopkins Medicine
NOT_YET_RECRUITING

Baltimore, Maryland, 21218, United States
Krakowski Szpital Specjalistyczny im. sw. Jana Pawla II
NOT_YET_RECRUITING

Krakow, 31-202, Poland
Louisiana State University (LSU) Health Sciences Center
NOT_YET_RECRUITING

New Orleans, Louisiana, 70112, United States
Maastricht University Medical Center
NOT_YET_RECRUITING

Maastricht, 6229 HX, Netherlands
Mayo Clinic - Jacksonville
NOT_YET_RECRUITING

Jacksonville, Florida, 32224, United States
Mayo Clinic - Rochester
NOT_YET_RECRUITING

Rochester, Minnesota, 55905, United States
MedStar Washington Hospital Center
NOT_YET_RECRUITING

Washington D.C., District of Columbia, 20010, United States
NHS Greater Glasgow and Clyde
NOT_YET_RECRUITING

Glasgow, G12 0YN, United Kingdom
NYU Langone Health
NOT_YET_RECRUITING

New York, New York, 10016, United States
Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy w Warszawie
NOT_YET_RECRUITING

Warsaw, 04-628, Poland
Northwestern University
NOT_YET_RECRUITING

Chicago, Illinois, 60611, United States
Odense University Hospital - Odense
NOT_YET_RECRUITING

Odense, 5000, Denmark
Oregon Health & Science University (OHSU)
NOT_YET_RECRUITING

Portland, Oregon, 97239, United States
Ospedale Policlinico Casilino
NOT_YET_RECRUITING

Roma, 00169, Italy
Rigshospitalet
NOT_YET_RECRUITING

Copenhagen, 1050, Denmark
Royal Brompton Hospital
NOT_YET_RECRUITING

London, SW3 6NP, United Kingdom
Saint Luke's Mid America Heart Institute
NOT_YET_RECRUITING

Kansas City, Missouri, 64111, United States
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
NOT_YET_RECRUITING

Lodz, 92-213, Poland
Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika
NOT_YET_RECRUITING

Budapest, 1122, Hungary
Sodersjukhuset AB
NOT_YET_RECRUITING

Stockholm, 11883, Sweden
St George's Hospital
NOT_YET_RECRUITING

London, SW17 0QT, United Kingdom
St. Bartholomew's Hospital
NOT_YET_RECRUITING

London, EC1A, United Kingdom
Stanford University Medical Center
NOT_YET_RECRUITING

Stanford, California, 94305, United States
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
NOT_YET_RECRUITING

Szeged, 6724, Hungary
The Lindner Center for Research and Education at The Christ Hospital
NOT_YET_RECRUITING

Cincinnati, Ohio, 45219, United States
The Ohio State University Wexner Medical Center
NOT_YET_RECRUITING

Columbus, Ohio, 43210, United States
UZ Leuven
NOT_YET_RECRUITING

Leuven, 3000, Belgium
Universitair Ziekenhuis Antwerpen (UZA)
NOT_YET_RECRUITING

Edegem, 2650, Belgium
Universite Libre de Bruxelles (ULB) - Hopital Erasme
NOT_YET_RECRUITING

Brussels, 1070, Belgium
University Hospitals Bristol NHS Foundation Trust
NOT_YET_RECRUITING

Bristol, BS1 3NU, United Kingdom
University of Alabama Birmingham
RECRUITING

Birmingham, Alabama, 35233, United States
University of California, Los Angeles (UCLA) - David Geffen School of Medicine
NOT_YET_RECRUITING

Los Angeles, California, 90095, United States
University of California, San Diego (UCSD) - Medical Center
NOT_YET_RECRUITING

San Diego, California, 92037, United States
University of California, San Francisco (UCSF)
NOT_YET_RECRUITING

San Francisco, California, 94158, United States
University of Minnesota
NOT_YET_RECRUITING

Minneapolis, Minnesota, 55455, United States
University of Nebraska Medical Center
NOT_YET_RECRUITING

Omaha, Nebraska, 68106, United States
University of Pennsylvania
NOT_YET_RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Uniwersyteckie Centrum Kliniczne, Gdansk
NOT_YET_RECRUITING

Gdansk, 80-952, Poland
Vanderbilt University Medical Center
NOT_YET_RECRUITING

Nashville, Tennessee, 37232, United States
Washington University in St. Louis
NOT_YET_RECRUITING

St Louis, Missouri, 63110, United States