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NCT07771465PHASE3Recruiting

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

Kardigan, Inc.

Start Date

8/26/2026

Completion Date

1/1/2033

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.

Detailed Description

The Sponsor is studying an investigational medication called danicamtiv to understand its long-term benefits and risks in patients with symptomatic genetic or familial DCM. This study will examine the durability of treatment effects with continued exposure and evaluate appropriateness of chronic dosing over time. Participants will: * Take the investigational medicine, danicamtiv, twice daily throughout the study, which is up to 5 years * Visit the clinic about 16 times for clinical evaluations and diagnostic tests

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Danicamtiv

Interested in This Trial?

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Conditions

Symptomatic Genetic Dilated Cardiomyopathy (DCM)

Locations

University of Alabama Birmingham

Birmingham, Alabama 35233

United States

Cedars Sinai

Los Angeles, California 90048

United States

University of California, Los Angeles (UCLA) - David Geffen School of Medicine

Los Angeles, California 90095

United States

University of California, San Diego (UCSD) - Medical Center

San Diego, California 92037

United States

University of California, San Francisco (UCSF)

San Francisco, California 94158

United States

Stanford University Medical Center

Stanford, California 94305

United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia 20010

United States

Mayo Clinic - Jacksonville

Jacksonville, Florida 32224

United States

Northwestern University

Chicago, Illinois 60611

United States

Louisiana State University (LSU) Health Sciences Center

New Orleans, Louisiana 70112

United States

Johns Hopkins Medicine

Baltimore, Maryland 21218

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Henry Ford Health System

Detroit, Michigan 48202

United States

University of Minnesota

Minneapolis, Minnesota 55455

United States

Mayo Clinic - Rochester

Rochester, Minnesota 55905

United States

Saint Luke's Mid America Heart Institute

Kansas City, Missouri 64111

United States

Washington University in St. Louis

St Louis, Missouri 63110

United States

University of Nebraska Medical Center

Omaha, Nebraska 68106

United States

NYU Langone Health

New York, New York 10016

United States

Columbia University Medical Center/ New York Presbyterian Hospital

New York, New York 10027

United States

Duke University Medical Center

Durham, North Carolina 27708

United States

The Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio 45219

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio 43210

United States

Oregon Health & Science University (OHSU)

Portland, Oregon 97239

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Baylor College of Medicine

Houston, Texas 77030

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

AZORG - Campus Moorselbaan

Aalst, 9300

Belgium

Universite Libre de Bruxelles (ULB) - Hopital Erasme

Brussels, 1070

Belgium

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, 2650

Belgium

Jessa Ziekenhuis

Hasselt, 3500

Belgium

UZ Leuven

Leuven, 3000

Belgium

Aarhus University Hospital

Aarhus, 8200

Denmark

Rigshospitalet

Copenhagen, 1050

Denmark

Odense University Hospital - Odense

Odense, 5000

Denmark

CHRU de Tours - Hopital Trousseau

Chambray-lès-Tours, 37170

France

CHU de Lille - Institut Coeur Poumon

Lille, 59037

France

AP-HP Hopital Pitie-Salpetriere

Paris, 75013

France

AP-HP Hopital Europeen Georges Pompidou

Paris, 75015

France

CHU Rennes - Hopital Pontchaillou

Rennes, 35033

France

Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika

Budapest, 1122

Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, 6724

Hungary

Azienda Ospedaliera Universitaria Consorziale - Policlinico Bari

Bari, 70124

Italy

Azienda Ospedaliero-Universitaria Careggi

Florence, 50314

Italy

IRCCS Ospedale San Raffaele

Milan, 20132

Italy

Centro Cardiologico Monzino

Milan, 20138

Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162

Italy

Azienda Ospedale - Università Padova

Padova, 35128

Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100

Italy

Ospedale Policlinico Casilino

Roma, 00169

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara

Trieste, 34100

Italy

Amsterdam UMC - Locatie AMC

Amsterdam, 1105-AZ

Netherlands

Maastricht University Medical Center

Maastricht, 6229 HX

Netherlands

Erasmus MC

Rotterdam, 3015 GD

Netherlands

Uniwersyteckie Centrum Kliniczne, Gdansk

Gdansk, 80-952

Poland

Krakowski Szpital Specjalistyczny im. sw. Jana Pawla II

Krakow, 31-202

Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, 92-213

Poland

Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy w Warszawie

Warsaw, 04-628

Poland

Hospital Universitario de A Coruña

A Coruña, 15006

Spain

Hospital Universitario Vall d'Hebron, Horta-Guinardó

Barcelona, 08035

Spain

Hospital Universitari de Bellvitge

Barcelona, 08907

Spain

Hospital Universitario Puerta de Hierro, Majadahonda, Madrid 20222

Madrid, 20222

Spain

Hospital Universitario Virgen de la Victoria

Málaga, 29001

Spain

Hospital Clinico Universitario Virgen de la Arrixaca

Murcia, 30120

Spain

Hospital Universitario Son Llatzer, Palma De Mallorca,

Palma de Mallorca, 7198

Spain

Hospital Universitario Virgen del Rocio

Seville, 41013

Spain

Sodersjukhuset AB

Stockholm, 11883

Sweden

Danderyds sjukhus

Stockholm, 182 88

Sweden

University Hospitals Bristol NHS Foundation Trust

Bristol, BS1 3NU

United Kingdom

NHS Greater Glasgow and Clyde

Glasgow, G12 0YN

United Kingdom

Glenfield hospital

Leicester, LE3 9QP

United Kingdom

St. Bartholomew's Hospital

London, EC1A

United Kingdom

St George's Hospital

London, SW17 0QT

United Kingdom

Royal Brompton Hospital

London, SW3 6NP

United Kingdom

Hammersmith Hospital, Imperial College of London

London, W12 0HS

United Kingdom

Cardiovascular Clinical Research Facility (CCRF)

Oxford, OX3 9DU

United Kingdom