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NCT07210723PHASE2, PHASE3Recruiting

A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy

Kardigan, Inc.

Start Date

2/13/2026

Completion Date

1/1/2028

Summary

The Sponsor is studying an investigational medication called danicamtiv to determine if it can help people with genetic and familial dilated cardiomyopathy (DCM). Investigational means that the safety and effectiveness of danicamtiv have not been established. Currently, there are no approved drugs that are designed specifically to treat genetic or familial DCM. The purpose of this study is to evaluate how well danicamtiv works compared to a placebo (sugar pill that looks like danicamtiv pill but does not contain any danicamtiv) and see how safe it is for people with genetic and familial DCM. In DCM, the heart muscle weakens and enlarges, making it harder for the heart to pump blood; this can happen for different reasons. Some people have DCM because of a change in a gene (called genetic DCM). Others may have DCM that runs in their family, even if no specific gene change is found (called familial DCM). The main goals of the study are: * To assess the effect of danicamtiv on cardiac function using echocardiogram. * To evaluate the impact of danicamtiv on exercise capacity * To evaluate the safety and tolerability of danicamtiv Participants will: * Take danicamtiv or placebo every day for approximately 6 months * Visit the clinic about 12 times for initial evaluation, checkups, tests and follow up

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: 1. Has a diagnosis of DCM due to probable disease-causing variants of MYH7, TTN, or other identified genetic DCM variants, or with familial DCM 2. Has New York Heart Association (NYHA) Class II-IV at Screening with stable symptoms for ≥1 month. 3. Has at least mild left ventricular enlargement (LVE) and has adequate acoustic windows to enable accurate TTEs according to the Echocardiography Core Laboratory. 4. Has a LVEF of ≤45%. 5. Is on stable doses of maximally tolerated standard-of-care heart failure (HF) therapies reflecting current guidelines for at least 4 weeks prior to the first visit. 6. Has DCM not attributed to substance abuse, amyloidosis, sarcoidosis, or any other secondary form of cardiomyopathy per the Investigator. 7. Can perform an upright cardiopulmonary exercise training (CPET) with a peak oxygen uptake (pV̇O2) of 80% or less of predicted for a healthy individual and respiratory exchange ratio (RER) of ≥1.05 Key Exclusion Criteria: 1. Has heart failure with reduced ejection (HFrEF) caused primarily by ischemic heart disease, chronic valvulopathy, or another condition, as determined by the Investigator. 2. Recent (\<90 days) clinically significant cardiac events, including acute coronary syndrome, hemodynamically significant epicardial coronary disease (per Investigator), coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\]), or hospitalization for heart failure/intravenous (IV) diuretic use. 3. Presence of disqualifying cardiac rhythms that might interfere with reliable echocardiographic measurements of left ventricle (LV) function, as determined by the Investigator including: (a) inadequately rate-controlled atrial fibrillation, (b) ectopic beats (atrial, junctional or ventricular) of sufficient frequency (e.g. \> 10% of total beats) that the participant's cardiac rhythm is irregular potentially interfering with reliable echocardiographic measurements of LV function. 4. Unstable or untreated severe ventricular arrythmia (eg, ventricular tachycardia or ventricular fibrillation). 5. History of malignancy of any type within 5 years prior to Screening 6. Severe renal insufficiency (defined at the time of Screening as current estimated glomerular filtration rate \[eGFR\] \<15 mL/min/1.73m2 by simplified Modification of Diet in Renal Disease equation \[sMDRD\]). 7. History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Sponsor, would pose a risk to participant safety or interfere with the study evaluation 8. History of heart transplantation or anticipated heart transplantation in the next 6 months. 9. Ongoing or anticipated advanced cardiac interventions, including chronic IV inotropic therapy, planned cardiac resynchronization therapy (CRT) or major surgery, or current/anticipated ventricular assist device placement within 6 months 10. Clinically significant laboratory abnormalities at Screening

Interventions

DRUG

danicamtiv

DRUG

Placebo

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Conditions

Symptomatic Genetic Dilated Cardiomyopathy

Locations

University of Alabama Birmingham

Birmingham, Alabama 35233

United States

Cedars Sinai

Los Angeles, California 90048

United States

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

San Diego, California 92037

United States

UCSF

San Francisco, California 94158

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

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

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

Universite Libre de Bruxelles (ULB) - Hopital Erasme

Brussels, 1070

Belgium

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, 2650

Belgium

Aarhus University Hospital

Aarhus, 8200

Denmark

Rigshospitalet

Copenhagen, 1050

Denmark

Odense University Hospital - Odense

Odense, 5000

Denmark

AP-HP Hopital Pitie-Salpetriere

Paris, 75013

France

AP-HP Hopital Europeen Georges Pompidou

Paris, 75015

France

Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika

Budapest, 1122

Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, 6724

Hungary

Azienda Ospedaliero-Universitaria Careggi

Florence, 50134

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

Erasmus MC

Rotterdam, 3015 GD

Netherlands

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

Hospital Universitario Vall d'Hebron

Horta-Guinardó, Barcelona 08035

Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid 20222

Spain

Hospital Universitario de A Coruña

A Coruña, 15006

Spain

Hospital Universitari de Bellvitge

Barcelona, 08907

Spain

Hospital Universitario Virgen de la Victoria

Málaga, 29001

Spain

Hospital Clinico Universitario Virgen de la Arrixaca

Murcia, 30120 El Palmar,

Spain

Hospital Universitario Son Llatzer

Palma de Mallorca, 7198

Spain

Hospital Universitario Virgen del Rocio

Seville, 41013

Spain

Sodersjukhuset AB

Stockholm, 11883

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