Symptomatic Genetic Dilated CardiomyopathyPhase 2/3KINSHIP-DCMNCT07210723
A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy
A Phase 2/3 study testing danicamtiv in people with Symptomatic Genetic Dilated Cardiomyopathy, run by Kardigan, Inc. at 79 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Genetic Dilated Cardiomyopathy
- What is being tested?
- danicamtiv
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- 79 sitesin 11 countries
- Study dates
- 13 Feb 2026to Jan 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Has a diagnosis of DCM due to probable disease-causing variants of MYH7, TTN, or other identified genetic DCM variants, or with familial DCM
- Has New York Heart Association (NYHA) Class II-IV at Screening with stable symptoms for ≥1 month.
- Has at least mild left ventricular enlargement (LVE) and has adequate acoustic windows to enable accurate TTEs according to the Echocardiography Core Laboratory.
- Has a LVEF of ≤45%.
- Is on stable doses of maximally tolerated standard-of-care heart failure (HF) therapies reflecting current guidelines for at least 4 weeks prior to the first visit.
- Has DCM not attributed to substance abuse, amyloidosis, sarcoidosis, or any other secondary form of cardiomyopathy per the Investigator.
- Can perform an upright cardiopulmonary exercise training (CPET) with a peak oxygen uptake (pV̇O2) of 80% or less of predicted for a healthy individual and respiratory exchange ratio (RER) of ≥1.05
Who cannot join
- Has heart failure with reduced ejection (HFrEF) caused primarily by ischemic heart disease, chronic valvulopathy, or another condition, as determined by the Investigator.
- Recent (<90 days) clinically significant cardiac events, including acute coronary syndrome, hemodynamically significant epicardial coronary disease (per Investigator), coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]), or hospitalization for heart failure/intravenous (IV) diuretic use.
- Presence of disqualifying cardiac rhythms that might interfere with reliable echocardiographic measurements of left ventricle (LV) function, as determined by the Investigator including: (a) inadequately rate-controlled atrial fibrillation, (b) ectopic beats (atrial, junctional or ventricular) of sufficient frequency (e.g. > 10% of total beats) that the participant's cardiac rhythm is irregular potentially interfering with reliable echocardiographic measurements of LV function.
- Unstable or untreated severe ventricular arrythmia (eg, ventricular tachycardia or ventricular fibrillation).
- History of malignancy of any type within 5 years prior to Screening
- Severe renal insufficiency (defined at the time of Screening as current estimated glomerular filtration rate [eGFR] <15 mL/min/1.73m2 by simplified Modification of Diet in Renal Disease equation [sMDRD]).
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- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Sponsor, would pose a risk to participant safety or interfere with the study evaluation
- History of heart transplantation or anticipated heart transplantation in the next 6 months.
- Ongoing or anticipated advanced cardiac interventions, including chronic IV inotropic therapy, planned cardiac resynchronization therapy (CRT) or major surgery, or current/anticipated ventricular assist device placement within 6 months
- Clinically significant laboratory abnormalities at Screening
Trial locations and contacts
79 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
79 sites in 11 countries
United States28 sites, 28 recruiting
- Recruiting
Johns Hopkins Medicine
Baltimore, Maryland, 21218
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- 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
- 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
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27708
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Saint Luke's Mid America Heart Institute
Kansas City, Missouri, 64111
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Cedars Sinai
Los Angeles, California, 90048
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet 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
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Louisiana State University (LSU) Health Sciences Center
New Orleans, Louisiana, 70112
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
NYU Langone Health
New York, New York, 10016
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- 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
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68106
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
University of California, San Diego (UCSD) - Medical Center
San Diego, California, 92037
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
UCSF
San Francisco, California, 94158
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Stanford University Medical Center
Stanford, California, 94305
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Italy10 sites, 10 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Consorziale - Policlinico Bari
Bari, 70124
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Azienda Ospedaliero-Universitaria Careggi
Florence, 50134
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
- Recruiting
Centro Cardiologico Monzino
Milan, 20138
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- 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
- Recruiting
Istituto Clinico Humanitas
Rozzano, 20089
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
Trieste, 34100
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
United Kingdom9 sites, 9 recruiting
- Recruiting
University Hospitals Bristol NHS Foundation Trust
Bristol, BS1 3NU
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Papworth Hospital
Cambridge
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
NHS Greater Glasgow and Clyde
Glasgow, G12 0YN
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Glenfield Hospital
Leicester, LE3 9QP
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
St. Bartholomew's Hospital
London, EC1A
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
St George's Hospital
London, SW17 0QT
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Royal Brompton Hospital
London, SW3 6NP
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- 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
Spain8 sites, 8 recruiting
- Recruiting
Hospital Universitario de A Coruña
A Coruña, 15006
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Hospital Universitari de Bellvitge
Barcelona, 08907
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Hospital Universitario Vall d'Hebron
Horta-Guinardó, Barcelona, 08035
Kardigan Clinical Trials Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 20222
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29001
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, 30120 El Palmar,
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Hospital Universitario Son Llatzer
Palma de Mallorca, 7198
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
Kardigan Clinical Trials Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Belgium5 sites, 5 recruiting
- Recruiting
AZORG - Campus Moorselbaan
Aalst, 9300
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Universite Libre de Bruxelles (ULB) - Hopital Erasme
Brussels, 1070
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, 2650
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Jessa Ziekenhuis
Hasselt, 3500
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
UZ Leuven
Leuven, 3000
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
France5 sites, 5 recruiting
- 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
- Recruiting
AP-HP Hopital Pitie-Salpetriere
Paris, 75013
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
AP-HP Hopital Europeen Georges Pompidou
Paris, 75015
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
CHU Rennes - Hopital Pontchaillou
Rennes, 35033
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Poland4 sites, 4 recruiting
- Not yet recruiting
Uniwersyteckie Centrum Kliniczne, Gdansk
Gdansk, 80-952
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Krakowski Szpital Specjalistyczny im. sw. Jana Pawla II
Krakow, 31-202
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- 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
- 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
Denmark3 sites, 3 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Rigshospitalet
Copenhagen, 1050
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Odense University Hospital - Odense
Odense, 5000
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Netherlands3 sites, 3 recruiting
- Recruiting
Amsterdam UMC - Locatie AMC
Amsterdam, 1105-AZ
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Maastricht University Medical Center
Maastricht, 6229 HX
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Erasmus MC
Rotterdam, 3015 GD
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Hungary2 sites, 2 recruiting
- Recruiting
Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika
Budapest, 1122
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6724
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Sweden2 sites, 2 recruiting
- Recruiting
Sodersjukhuset AB
Stockholm, 11883
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Danderyds sjukhus
Stockholm, 182 88
Kardigan Clinical Trial Team, 1-877-310-5135, clinicaltrials@kardigan.bio
About this study
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
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).
Read more
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
- Being tested
- danicamtiv, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
danicamtivDrug
Danicamtiv will be administrated twice daily for up to 26 weeks
PlaceboDrug
Placebo will be administrated twice daily for up to 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| danicamtiv | Experimental | Not described Receives: Drug: danicamtiv |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Change from Baseline (Day 1) to Week 26 in left atrial function index in Cohort 1
Measured: 26 weeks
Part 2: Change from Baseline (Day 1) to Week 26 in peak VO2 in Cohort 1
Measured: 26 weeks
Secondary outcomes (14)
Part 1: Change from Baseline (Day 1) to Week 26 in peak VO2
Measured: 26 weeks
Part 1: Association between response in left ventricular global longitudinal strain and/or left atrial function index after 2 weeks of active treatment with placebo-adjusted Week 26 response in peak VO2
Measured: 26 weeks
Part 1: Change from Baseline (Day 1) to Week 26 in left atrial function index in overall population
Measured: 26 weeks
Part 1 and 2: Change from Baseline (Day 1) to Week 26 in left ventricular ejection fraction
Measured: 26 weeks
Part 1 and 2: Change from Baseline (Day 1) to Week 26 in ventilatory efficiency
Measured: 26 weeks
Part 1 and 2: Change from Baseline (Day 1) to Week 26 in Kansas City Cardiomyopathy Questionnare (KCCQ-23) Clinical Summary Score
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: 26 weeks
Part 1: Proportion of participants from Baseline (Day 1) to Week 26 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: 26 weeks
Part 2: Change from Baseline (Day 1) to Week 26 in left atrial function index
Measured: 26 weeks
Part 2: Change from Baseline (Day 1) to Week 26 in peak VO2 in the responder subgroup
Measured: 26 weeks
Part 2: Change from Baseline (Day 1) to Week 26 in peak VO2 in overall population
Measured: 26 weeks
Part 1 and 2: Change from Baseline (Day 1) to Week 26 in left ventricular global longitudinal strain
Measured: 26 weeks
Part 1 and 2: Percent change from Baseline (Day 1) to Week 26 in NT-proBNP concentrations
Measured: 26 weeks
Part 1 and 2: Characterization of peak (Cmax) of danicamtiv
Measured: 20 weeks
Part 1 and 2: Characterization of trough (Cmin) plasma concentrations of danicamtiv
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start13 Feb 2026
- Primary completionSep 2027 (estimated)
- Study completionJan 2028 (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 CardiomyopathyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kardigan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210723
- Sponsor's protocol ID
- DAN-301
- Acronym
- KINSHIP-DCM
- Status last verified
- Mar 2026
- First submitted
- 23 Sep 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07210723
- Acronym / sponsor ID
- KINSHIP-DCM / DAN-301
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Kardigan, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| danicamtiv | Experimental | Drug: danicamtiv |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has a diagnosis of DCM due to probable disease-causing variants of MYH7, TTN, or other identified genetic DCM variants, or with familial DCM
- Has New York Heart Association (NYHA) Class II-IV at Screening with stable symptoms for ≥1 month.
- Has at least mild left ventricular enlargement (LVE) and has adequate acoustic windows to enable accurate TTEs according to the Echocardiography Core Laboratory.
- Has a LVEF of ≤45%.
- Is on stable doses of maximally tolerated standard-of-care heart failure (HF) therapies reflecting current guidelines for at least 4 weeks prior to the first visit.
Key exclusion criteria (10 listed)
- Has heart failure with reduced ejection (HFrEF) caused primarily by ischemic heart disease, chronic valvulopathy, or another condition, as determined by the Investigator.
- Recent (<90 days) clinically significant cardiac events, including acute coronary syndrome, hemodynamically significant epicardial coronary disease (per Investigator), coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]), or hospitalization for heart failure/intravenous (IV) diuretic use.
- Presence of disqualifying cardiac rhythms that might interfere with reliable echocardiographic measurements of left ventricle (LV) function, as determined by the Investigator including: (a) inadequately rate-controlled atrial fibrillation, (b) ectopic beats (atrial, junctional or ventricular) of sufficient frequency (e.g. > 10% of total beats) that the participant's cardiac rhythm is irregular potentially interfering with reliable echocardiographic measurements of LV function.
- Unstable or untreated severe ventricular arrythmia (eg, ventricular tachycardia or ventricular fibrillation).
- History of malignancy of any type within 5 years prior to Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| danicamtivDanicamtiv will be administrated twice daily for up to 26 weeks | Drug | danicamtiv |
| PlaceboPlacebo will be administrated twice daily for up to 26 weeks | Drug | placebo |
Primary outcome
Part 1: Change from Baseline (Day 1) to Week 26 in left atrial function index in Cohort 1
Time frame: 26 weeks
Part 2: Change from Baseline (Day 1) to Week 26 in peak VO2 in Cohort 1
Time frame: 26 weeks
14 secondary outcomes
Part 1: Change from Baseline (Day 1) to Week 26 in peak VO2
Time frame: 26 weeks
Part 1: Association between response in left ventricular global longitudinal strain and/or left atrial function index after 2 weeks of active treatment with placebo-adjusted Week 26 response in peak VO2
Time frame: 26 weeks
Part 1: Change from Baseline (Day 1) to Week 26 in left atrial function index in overall population
Time frame: 26 weeks
Part 1 and 2: Change from Baseline (Day 1) to Week 26 in left ventricular ejection fraction
Time frame: 26 weeks
Part 1 and 2: Change from Baseline (Day 1) to Week 26 in ventilatory efficiency
Time frame: 26 weeks
Part 1 and 2: Change from Baseline (Day 1) to Week 26 in Kansas City Cardiomyopathy Questionnare (KCCQ-23) Clinical Summary Score
Time frame: 26 weeks
Part 1: Proportion of participants from Baseline (Day 1) to Week 26 who achieve at least a one-class improvement in New York Heart Association (NYHA) class
Time frame: 26 weeks
Part 2: Change from Baseline (Day 1) to Week 26 in left atrial function index
Time frame: 26 weeks
Part 2: Change from Baseline (Day 1) to Week 26 in peak VO2 in the responder subgroup
Time frame: 26 weeks
Part 2: Change from Baseline (Day 1) to Week 26 in peak VO2 in overall population
Time frame: 26 weeks
Part 1 and 2: Change from Baseline (Day 1) to Week 26 in left ventricular global longitudinal strain
Time frame: 26 weeks
Part 1 and 2: Percent change from Baseline (Day 1) to Week 26 in NT-proBNP concentrations
Time frame: 26 weeks
Part 1 and 2: Characterization of peak (Cmax) of danicamtiv
Time frame: 20 weeks
Part 1 and 2: Characterization of trough (Cmin) plasma concentrations of danicamtiv
Time frame: 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Symptomatic Genetic Dilated Cardiomyopathy
RecruitingPhase 3
A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Symptomatic Genetic Dilated Cardiomyopathy (DCM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
79 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing danicamtiv in people with Symptomatic Genetic Dilated Cardiomyopathy, run by Kardigan, Inc. at 79 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Italy, United Kingdom, Spain, Belgium and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kardigan Clinical Trial Information Team (1-877-310-5135, clinicaltrials@kardigan.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Change from Baseline (Day 1) to Week 26 in left atrial function index in Cohort 1 (time frame: 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.