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RECRUITING

NCT07210723

PHASE2/PHASE3

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

Sponsor: Kardigan, Inc.

View on ClinicalTrials.gov

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

Official title: A Phase 2b/3, Adaptive, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

332

Start Date

2026-02-13

Completion Date

2028-01

Last Updated

2026-07-06

Healthy Volunteers

Conditions

Symptomatic Genetic Dilated Cardiomyopathy

Interventions

DRUG

danicamtiv

Danicamtiv will be administrated twice daily for up to 26 weeks

DRUG

Placebo

Placebo will be administrated twice daily for up to 26 weeks

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

Locations (56)

University of Alabama Birmingham

Birmingham, Alabama, United States

Cedars Sinai

Los Angeles, California, United States

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

San Diego, California, United States

UCSF

San Francisco, 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

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

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

Universite Libre de Bruxelles (ULB) - Hopital Erasme

Brussels, Belgium

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Belgium

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense University Hospital - Odense

Odense, Denmark

AP-HP Hopital Pitie-Salpetriere

Paris, France

AP-HP Hopital Europeen Georges Pompidou

Paris, France

Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika

Budapest, Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, Hungary

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Istituto Clinico Humanitas

Rozzano, Italy

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

Trieste, Italy

Amsterdam UMC - Locatie AMC

Amsterdam, Netherlands

Erasmus MC

Rotterdam, Netherlands

Krakowski Szpital Specjalistyczny im. sw. Jana Pawla II

Krakow, Poland

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

Lodz, Poland

Hospital Universitario Vall d'Hebron

Horta-Guinardó, Barcelona, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Hospital Universitario de A Coruña

A Coruña, Spain

Hospital Universitari de Bellvitge

Barcelona, 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, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Sodersjukhuset AB

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (56)