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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

2026-03-27

Healthy Volunteers

No

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

Locations (26)

University of Alabama Birmingham

Birmingham, Alabama, United States

Cedars Sinai

Los Angeles, California, United States

UCSF

San Francisco, California, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 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

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

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Aarhus University Hospital

Aarhus, Denmark

AP-HP Hopital Pitie-Salpetriere

Paris, France

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 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

NHS Greater Glasgow and Clyde

Glasgow, 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