An Open-label Extension Study to Assess the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Status: Recruiting
Location: See all (78) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Danicamtiv is an investigational medication, which means it is still being studied and has not been approved. The purpose of this study is to learn how well danicamtiv works, how safe it is, how well people can take it when used in patients with genetic or familial dilated cardiomyopathy (DCM). There are currently no approved medicines made specifically to treat genetic or familial DCM.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Completed 24 weeks of blinded study treatment (corresponding to the Week 26 Visit in DAN-301) and planned assessments in Part 1 or Part 2 of the DAN-301 study.
• If sexually active, must use a highly effective birth control method from the Screening Visit through 3 months after the last dose.
• Is able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent according to local and institutional guidelines before the first study-specific procedure.
Locations
United States
Alabama
University of Alabama Birmingham
RECRUITING
Birmingham
California
Cedars Sinai
NOT_YET_RECRUITING
Los Angeles
University of California, Los Angeles (UCLA) - David Geffen School of Medicine
NOT_YET_RECRUITING
Los Angeles
University of California, San Diego (UCSD) - Medical Center
NOT_YET_RECRUITING
San Diego
University of California, San Francisco (UCSF)
NOT_YET_RECRUITING
San Francisco
Stanford University Medical Center
NOT_YET_RECRUITING
Stanford
Washington, D.c.
MedStar Washington Hospital Center
NOT_YET_RECRUITING
Washington D.c.
Florida
Mayo Clinic - Jacksonville
NOT_YET_RECRUITING
Jacksonville
Illinois
Northwestern University
NOT_YET_RECRUITING
Chicago
Louisiana
Louisiana State University (LSU) Health Sciences Center
NOT_YET_RECRUITING
New Orleans
Massachusetts
Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
Maryland
Johns Hopkins Medicine
NOT_YET_RECRUITING
Baltimore
Michigan
Henry Ford Health System
NOT_YET_RECRUITING
Detroit
Minnesota
University of Minnesota
NOT_YET_RECRUITING
Minneapolis
Mayo Clinic - Rochester
NOT_YET_RECRUITING
Rochester
Missouri
Saint Luke's Mid America Heart Institute
NOT_YET_RECRUITING
Kansas City
Washington University in St. Louis
NOT_YET_RECRUITING
St Louis
North Carolina
Duke University Medical Center
NOT_YET_RECRUITING
Durham
Nebraska
University of Nebraska Medical Center
NOT_YET_RECRUITING
Omaha
New York
Columbia University Medical Center/ New York Presbyterian Hospital
NOT_YET_RECRUITING
New York
NYU Langone Health
NOT_YET_RECRUITING
New York
Ohio
The Lindner Center for Research and Education at The Christ Hospital
NOT_YET_RECRUITING
Cincinnati
The Ohio State University Wexner Medical Center
NOT_YET_RECRUITING
Columbus
Oregon
Oregon Health & Science University (OHSU)
NOT_YET_RECRUITING
Portland
Pennsylvania
University of Pennsylvania
NOT_YET_RECRUITING
Philadelphia
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Texas
Baylor College of Medicine
NOT_YET_RECRUITING
Houston
Houston Methodist Hospital
NOT_YET_RECRUITING
Houston
Other Locations
Belgium
AZORG - Campus Moorselbaan
NOT_YET_RECRUITING
Aalst
Universite Libre de Bruxelles (ULB) - Hopital Erasme
NOT_YET_RECRUITING
Brussels
Universitair Ziekenhuis Antwerpen (UZA)
NOT_YET_RECRUITING
Edegem
Jessa Ziekenhuis
NOT_YET_RECRUITING
Hasselt
UZ Leuven
NOT_YET_RECRUITING
Leuven
Denmark
Aarhus University Hospital
NOT_YET_RECRUITING
Aarhus
Rigshospitalet
NOT_YET_RECRUITING
Copenhagen
Odense University Hospital - Odense
NOT_YET_RECRUITING
Odense
France
CHRU de Tours - Hopital Trousseau
NOT_YET_RECRUITING
Chambray-lès-tours
CHU de Lille - Institut Coeur Poumon
NOT_YET_RECRUITING
Lille
AP-HP Hopital Europeen Georges Pompidou
NOT_YET_RECRUITING
Paris
AP-HP Hopital Pitie-Salpetriere
NOT_YET_RECRUITING
Paris
CHU Rennes - Hopital Pontchaillou
NOT_YET_RECRUITING
Rennes
Hungary
Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika
NOT_YET_RECRUITING
Budapest
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
NOT_YET_RECRUITING
Szeged
Italy
Azienda Ospedaliera Universitaria Consorziale - Policlinico Bari
NOT_YET_RECRUITING
Bari
Azienda Ospedaliero-Universitaria Careggi
NOT_YET_RECRUITING
Florence
ASST Grande Ospedale Metropolitano Niguarda
NOT_YET_RECRUITING
Milan
Centro Cardiologico Monzino
NOT_YET_RECRUITING
Milan
IRCCS Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
Azienda Ospedale - Università Padova
NOT_YET_RECRUITING
Padova
Fondazione IRCCS Policlinico San Matteo
NOT_YET_RECRUITING
Pavia
Ospedale Policlinico Casilino
NOT_YET_RECRUITING
Roma
Istituto Clinico Humanitas
NOT_YET_RECRUITING
Rozzano
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
NOT_YET_RECRUITING
Trieste
Netherlands
Amsterdam UMC - Locatie AMC
NOT_YET_RECRUITING
Amsterdam
Maastricht University Medical Center
NOT_YET_RECRUITING
Maastricht
Erasmus MC
NOT_YET_RECRUITING
Rotterdam
Poland
Uniwersyteckie Centrum Kliniczne, Gdansk
NOT_YET_RECRUITING
Gdansk
Krakowski Szpital Specjalistyczny im. sw. Jana Pawla II
NOT_YET_RECRUITING
Krakow
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
NOT_YET_RECRUITING
Lodz
Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy w Warszawie
NOT_YET_RECRUITING
Warsaw
Spain
Hospital Universitario de A Coruña
NOT_YET_RECRUITING
A Coruña
Hospital Universitari de Bellvitge
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron, Horta-Guinardó
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid 20222
NOT_YET_RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
NOT_YET_RECRUITING
Málaga
Hospital Clinico Universitario Virgen de la Arrixaca
NOT_YET_RECRUITING
Murcia
Hospital Universitario Son Llatzer, Palma De Mallorca,
NOT_YET_RECRUITING
Palma De Mallorca
Hospital Universitario Virgen del Rocio
NOT_YET_RECRUITING
Seville
Sweden
Danderyds sjukhus
NOT_YET_RECRUITING
Stockholm
Sodersjukhuset AB
NOT_YET_RECRUITING
Stockholm
United Kingdom
University Hospitals Bristol NHS Foundation Trust
NOT_YET_RECRUITING
Bristol
NHS Greater Glasgow and Clyde
NOT_YET_RECRUITING
Glasgow
Glenfield hospital
NOT_YET_RECRUITING
Leicester
Hammersmith Hospital, Imperial College of London
NOT_YET_RECRUITING
London
Royal Brompton Hospital
NOT_YET_RECRUITING
London
St George's Hospital
NOT_YET_RECRUITING
London
St. Bartholomew's Hospital
NOT_YET_RECRUITING
London
Cardiovascular Clinical Research Facility (CCRF)
NOT_YET_RECRUITING
Oxford
Contact Information
Primary
Kardigan Clinical Trial Information Team
clinicaltrials@kardigan.bio
1-877-310-5135
Time Frame
Start Date: 2026-08-26
Estimated Completion Date: 2033-01
Participants
Target number of participants: 332
Treatments
Experimental: Danicamtiv
Related Therapeutic Areas
Sponsors
Leads: Kardigan, Inc.