Symptomatic Genetic Dilated Cardiomyopathy (DCM)Phase 3KINSHIP-OLENCT07771465

A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy

A Phase 3 study testing Danicamtiv in people with Symptomatic Genetic Dilated Cardiomyopathy (DCM), run by Kardigan, Inc. at 78 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Symptomatic Genetic Dilated Cardiomyopathy (DCM)
What is being tested?: Danicamtiv
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 332 participants
Where: 78 sitesin 11 countries
Study dates: 26 Aug 2026to Jan 2033
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Acute coronary syndrome or hemodynamically significant epicardial coronary disease, or coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]) performed within 90 days of DAN-302 Screening Visit.
Recent (<90 days) hospitalization for heart failure (HF) or use of IV diuretic.
Other recent (<90 days) cardiovascular events (e.g., cerebrovascular accident).
Hospitalization for sepsis or other systemic infections within 30 days of Screening. A systemic infection includes suspected or confirmed infection associated with fever, hemodynamic instability, bacteremia, or organ dysfunction typically requires urgent evaluation and/or acute care.
Any malignancy requiring treatment after enrollment in DAN-301 that could limit patient's survival.

Trial locations and contacts

78 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Kardigan Clinical Trial Information Team contact

1-877-310-5135

clinicaltrials@kardigan.bio

Country

City, postcode or hospital

Sites recruiting now only

78 sites in 11 countries

United States28 sites, 28 recruiting

Johns Hopkins Medicine
Baltimore, Maryland, 21218
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
University of Alabama Birmingham
Birmingham, Alabama, 35233
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Recruiting
Northwestern University
Chicago, Illinois, 60611
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Duke University Medical Center
Durham, North Carolina, 27708
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Baylor College of Medicine
Houston, Texas, 77030
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Saint Luke's Mid America Heart Institute
Kansas City, Missouri, 64111
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Cedars Sinai
Los Angeles, California, 90048
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Recruiting
University of California, Los Angeles (UCLA) - David Geffen School of Medicine
Los Angeles, California, 90095
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Louisiana State University (LSU) Health Sciences Center
New Orleans, Louisiana, 70112
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
NYU Langone Health
New York, New York, 10016
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Columbia University Medical Center/ New York Presbyterian Hospital
New York, New York, 10027
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68106
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
University of California, San Diego (UCSD) - Medical Center
San Diego, California, 92037
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
University of California, San Francisco (UCSF)
San Francisco, California, 94158
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Stanford University Medical Center
Stanford, California, 94305
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting

Other trials in United States

Italy10 sites, 10 recruiting

Azienda Ospedaliera Universitaria Consorziale - Policlinico Bari
Bari, 70124
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Azienda Ospedaliero-Universitaria Careggi
Florence, 50314
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
IRCCS Ospedale San Raffaele
Milan, 20132
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Centro Cardiologico Monzino
Milan, 20138
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Azienda Ospedale - Università Padova
Padova, 35128
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Ospedale Policlinico Casilino
Roma, 00169
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Istituto Clinico Humanitas
Rozzano, 20089
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
Trieste, 34100
Kardigan Clinical Trial Team, 1-877-310-5135
Not yet recruiting

Other trials in Italy

Spain8 sites, 8 recruiting

Hospital Universitario de A Coruña
A Coruña, 15006
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Hospital Universitario Vall d'Hebron, Horta-Guinardó
Barcelona, 08035
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Hospital Universitari de Bellvitge
Barcelona, 08907
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid 20222
Madrid, 20222
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29001
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, 30120
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Hospital Universitario Son Llatzer, Palma De Mallorca,
Palma de Mallorca, 7198
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting

Other trials in Spain

United Kingdom8 sites, 8 recruiting

University Hospitals Bristol NHS Foundation Trust
Bristol, BS1 3NU
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
NHS Greater Glasgow and Clyde
Glasgow, G12 0YN
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Glenfield hospital
Leicester, LE3 9QP
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
St. Bartholomew's Hospital
London, EC1A
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
St George's Hospital
London, SW17 0QT
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Royal Brompton Hospital
London, SW3 6NP
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Hammersmith Hospital, Imperial College of London
London, W12 0HS
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Recruiting
Cardiovascular Clinical Research Facility (CCRF)
Oxford, OX3 9DU
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting

Other trials in United Kingdom

Belgium5 sites, 5 recruiting

AZORG - Campus Moorselbaan
Aalst, 9300
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Universite Libre de Bruxelles (ULB) - Hopital Erasme
Brussels, 1070
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, 2650
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Jessa Ziekenhuis
Hasselt, 3500
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
UZ Leuven
Leuven, 3000
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting

Other trials in Belgium

France5 sites, 5 recruiting

CHRU de Tours - Hopital Trousseau
Chambray-lès-Tours, 37170
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
CHU de Lille - Institut Coeur Poumon
Lille, 59037
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
AP-HP Hopital Pitie-Salpetriere
Paris, 75013
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
AP-HP Hopital Europeen Georges Pompidou
Paris, 75015
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
CHU Rennes - Hopital Pontchaillou
Rennes, 35033
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting

Other trials in France

Poland4 sites, 4 recruiting

Uniwersyteckie Centrum Kliniczne, Gdansk
Gdansk, 80-952
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Krakowski Szpital Specjalistyczny im. sw. Jana Pawla II
Krakow, 31-202
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, 92-213
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy w Warszawie
Warsaw, 04-628
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting

Other trials in Poland

Denmark3 sites, 3 recruiting

Aarhus University Hospital
Aarhus, 8200
Not yet recruiting
Rigshospitalet
Copenhagen, 1050
Rigshospitalet
Not yet recruiting
Odense University Hospital - Odense
Odense, 5000
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting

Other trials in Denmark

Netherlands3 sites, 3 recruiting

Amsterdam UMC - Locatie AMC
Amsterdam, 1105-AZ
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Maastricht University Medical Center
Maastricht, 6229 HX
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Erasmus MC
Rotterdam, 3015 GD
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting

Other trials in Netherlands

Hungary2 sites, 2 recruiting

Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika
Budapest, 1122
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6724
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting

Other trials in Hungary

Sweden2 sites, 2 recruiting

Sodersjukhuset AB
Stockholm, 11883
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting
Danderyds sjukhus
Stockholm, 182 88
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Not yet recruiting

Other trials in Sweden

About this study

Official title: An Open-label Extension Study to Assess the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy

Read the detailed description

The Sponsor is studying an investigational medication called danicamtiv to understand its long-term benefits and risks in patients with symptomatic genetic or familial DCM. This study will examine the durability of treatment effects with continued exposure and evaluate appropriateness of chronic dosing over time.

Participants will:

Take the investigational medicine, danicamtiv, twice daily throughout the study, which is up to 5 years
Visit the clinic about 16 times for clinical evaluations and diagnostic tests

Conditions: Symptomatic Genetic Dilated Cardiomyopathy (DCM)
Being tested: Danicamtiv

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DanicamtivDrug
Danicamtiv will be administered twice daily for up to 5 years

Study groups in NCT07771465
Study group	Role	What they receive
Danicamtiv	Experimental	Not described Receives: Drug: Danicamtiv

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency and severity of treatment-emergent adverse events (TEAEs)
Measured: 61 months
Frequency and severity of adverse events of special interest (AESIs)
Measured: 61 months
Frequency and severity of serious adverse events (SAEs)
Measured: 61 months
Frequency and severity of disease-related events (DREs)
Measured: 61 months
Frequency of abnormal findings from physical examination
Measured: 61 months
Frequency of abnormal findings from vital signs
Measured: 61 months
Frequency of abnormal findings from 12-lead electrocardiograms (ECGs)
Measured: 61 months
Frequency of abnormal findings from clinical laboratory assessments
Measured: 61 months

Secondary outcomes (6)

Change from Baseline (Day 1) to Week 26, Months 18, 30, 42, 54, 60, and 61 in cardiac structure, function, and size using Transthoracic Echocardiogram (TTE)
Including but not limited to left atrial function index (LAFI), left atrial volume index (LAVI), maximum left atrial volume index (LAmaxVi), minimum left atrial volume index (LAminVi), left atrial emptying fraction (LAEF), left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDD), left ventricular end diastolic volume (LVEDV), left ventricular end systolic volume (LVESV), early diastolic mitral inflow velocity/early diastolic mitral annular tissue velocity (E/e'), left ventricular global longitudinal strain (LVGLS), left ventricular global circumferential strain (LVGCS), and left ventricular mass index (LVMI)
Measured: 61 months
Change from Baseline (Day 1) to Week 26, Months 12, 18, 24, 30, 36, 42, 48, 54, 60, and 61 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-23 CSS)
All scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Measured: 61 months
Change from Baseline (Day 1) to Week 26, Months 12, 18, 24, 30, 36, 42, 48, 54, 60, and 61 in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Utility Score
Measured: 61 months
Change from Baseline (Day 1) to Week 26, Months 12, 18, 24, 30, 36, 42, 48, 54, 60, and 61 in EuroQol Visual Analogue Scale (EQ-VAS) Score
Measured: 61 months
Proportion of participants from Baseline (Day 1) to Week 26, Months 12, 18, 24, 30, 36, 42, 48, 54, 60, and 61 who achieve at least a one-class improvement in New York Heart Association (NYHA) class
NYHA is a system used to categorize the severity of heart failure symptoms based on a patient's functional capacity, where 1 indicates no symptoms or limitations and 4 indicates symptoms present at rest.
Measured: 61 months
Change from Baseline (Day 1) to Week 26, Months 12, 18, 24, 30, 36, 42, 48, 54, 60, and 61 in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations
Measured: 61 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Aug 2026Jan 2033

First posted18 Aug 2026
Study start26 Aug 2026
Primary completionNov 2032 (estimated)
Study completionJan 2033 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Symptomatic Genetic Dilated Cardiomyopathy (DCM)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Global, multicenter study of danicamtiv in participants with symptomatic genetic or familial DCM who previously completed Part 1 or Part 2 of DAN-301 study. Once eligibility is confirmed, participants will receive danicamtiv twice daily dosing.
Masking: None (open label)
Enrolment: 332 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07771465
Sponsor's protocol ID: DAN-302
Acronym: KINSHIP-OLE
Status last verified: Aug 2026
First submitted: 20 Jul 2026
Last updated: 2 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No