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A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Sponsor: Kardigan, Inc.
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
danicamtiv
Danicamtiv will be administrated twice daily for up to 26 weeks
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