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Clinical Trials in the UK / NCT07210723
Recruiting Phase 2/3

A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy

NCT07210723 · tracked via the Priya Life Science UK tracker
Sponsor
Kardigan, Inc.
Phase
Phase 2/3
Started
2026-02-13
Last updated
2026-08-04

Condition(s) studied

Symptomatic Genetic Dilated Cardiomyopathy

Investigational drug(s) / intervention(s)

danicamtivPlacebo

danicamtiv: Danicamtiv will be administrated twice daily for up to 26 weeks

Placebo: Placebo will be administrated twice daily for up to 26 weeks

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: 1. Has a diagnosis of DCM due to probable disease-causing variants of MYH7, TTN, or other identified genetic DCM variants, or with familial DCM 2. Has New York Heart Association (NYHA) Class II-IV at Screening with stable symptoms for ≥1 month. 3. Has at least mild left ventricular enlargement (LVE) and has adequate acoustic windows to enable accurate TTEs according to the Echocardiography Core Laboratory. 4. Has a LVEF of ≤45%. 5. 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. 6. Has DCM not attributed to substance abuse, amyloidosis, sarcoidosis, or any other secondary form of cardiomyopathy per the Investigator. 7. 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 Key Exclusion Criteria: 1. Has heart failure with reduced ejection (HFrEF) caused primarily by ischemic heart disease, chronic valvulopathy, or another condition, as determined by the Investigator. 2. 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. 3. 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. 4. Unstable or untreated severe ventricular arrythmia (eg, ventricular tachycardia or ventricular fibrillation). 5. History of malignancy of any type within 5 years prior to Screening 6. 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 \[sMDRD\]). 7. 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 8. History of heart transplantation or anticipated heart transplantation in the next 6 months. 9. 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 10. Clinically significant laboratory abnormalities at Screening

Primary outcome measure(s)

Trial sites (78)

FacilityCityRegionStatus
University of Alabama Birmingham Birmingham Alabama Recruiting
Cedars Sinai Los Angeles California Recruiting
University of California, Los Angeles (UCLA) - David Geffen School of Medicine Los Angeles California Not Yet Recruiting
University of California, San Diego (UCSD) - Medical Center San Diego California Recruiting
UCSF San Francisco California Recruiting
Stanford University Medical Center Stanford California Not Yet Recruiting
MedStar Washington Hospital Center Washington D.C. District of Columbia Recruiting
Mayo Clinic - Jacksonville Jacksonville Florida Recruiting
Northwestern University Chicago Illinois Recruiting
Louisiana State University (LSU) Health Sciences Center New Orleans Louisiana Recruiting
Johns Hopkins Medicine Baltimore Maryland Not Yet Recruiting
Brigham and Women's Hospital Boston Massachusetts Recruiting
Henry Ford Health System Detroit Michigan Recruiting
University of Minnesota Minneapolis Minnesota Recruiting
Mayo Clinic Rochester Rochester Minnesota Recruiting
Saint Luke's Mid America Heart Institute Kansas City Missouri Not Yet Recruiting
Washington University in St. Louis St Louis Missouri Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
NYU Langone Health New York New York Recruiting
Columbia University Medical Center/ New York Presbyterian Hospital New York New York Not Yet Recruiting
Duke University Medical Center Durham North Carolina Recruiting
The Lindner Center for Research and Education at The Christ Hospital Cincinnati Ohio Recruiting
The Ohio State University Wexner Medical Center Columbus Ohio Recruiting
Oregon Health & Science University (OHSU) Portland Oregon Recruiting
University of Pennsylvania Philadelphia Pennsylvania Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Baylor College of Medicine Houston Texas Recruiting
Houston Methodist Hospital Houston Texas Not Yet Recruiting
AZORG - Campus Moorselbaan Aalst Belgium Recruiting
Universite Libre de Bruxelles (ULB) - Hopital Erasme Brussels Belgium Recruiting
Universitair Ziekenhuis Antwerpen (UZA) Edegem Belgium Recruiting
Jessa Ziekenhuis Hasselt Belgium Not Yet Recruiting
UZ Leuven Leuven Belgium Recruiting
Aarhus University Hospital Aarhus Denmark Recruiting
Rigshospitalet Copenhagen Denmark Recruiting
Odense University Hospital - Odense Odense Denmark Recruiting
CHRU de Tours - Hopital Trousseau Chambray-lès-Tours France Not Yet Recruiting
CHU de Lille - Institut Coeur Poumon Lille France Not Yet Recruiting
AP-HP Hopital Pitie-Salpetriere Paris France Recruiting
AP-HP Hopital Europeen Georges Pompidou Paris France Recruiting

+ 38 more sites — see the full list on the official registry below.

More Kardigan, Inc. trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07210723 on ClinicalTrials.gov ↗ ← All trials in the UK