A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy
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
Interventions
danicamtiv
Placebo
Conditions
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
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, 50134
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 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
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