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Looking for participantsPhase2/Phase3

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

Sponsor: Kardigan, Inc.

NCT ID: NCT07210723

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
danicamtiv (drug), Placebo (drug)
How long the study runs
Study runs about 23 months (dates as stated)
About the drug or intervention
danicamtiv — drug: Danicamtiv will be administrated twice daily for up to 26 weeks · Placebo — drug: Placebo will be administrated twice daily for up to 26 weeks
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at how well a medicine called danicamtiv works and how safe it is in people with symptomatic genetic or familial dilated cardiomyopathy (a condition where the heart muscle becomes stretched and weak, often running in families). The study is funded by Kardigan, Inc.

Who can take part

  • You have dilated cardiomyopathy linked to a genetic change (such as in the MYH7 or TTN genes) or a family history of the condition.
  • You have heart failure symptoms (New York Heart Association Class II to IV) that have been stable for at least 1 month.
  • Your heart's left ventricle (main pumping chamber) is at least mildly enlarged, and heart scans (echocardiograms) can take clear pictures of it.
  • Your heart pumps out 45% or less of its blood with each beat (this measure is called LVEF).
  • You have been on stable doses of the standard heart failure medicines you can tolerate for at least 4 weeks before the first visit.
  • Your condition is not caused by substance abuse, amyloidosis, sarcoidosis, or another secondary cause.
  • You can do an exercise test on a bike or treadmill while breathing measurements are taken, with results below a set level (peak oxygen uptake 80% or less than predicted, and a breathing exchange measure of 1.05 or more).

Who may not be able to

  • Your heart failure is mainly caused by narrowed heart arteries, heart valve disease, or another condition.
  • You have had a serious heart event in the last 90 days, such as a heart attack, heart artery procedure, hospital stay for heart failure, or water-tablet medicine given through a drip.
  • You have a heart rhythm problem that would make heart scan measurements unreliable, such as poorly controlled atrial fibrillation or frequent extra heartbeats (more than 10% of beats).
  • You have unstable or untreated serious abnormal heart rhythms, such as ventricular tachycardia or ventricular fibrillation.
  • You have had any type of cancer in the last 5 years.
  • Your kidneys are working very poorly (a filtering measure called eGFR below 15).
  • You have another condition or disease that the study doctor or sponsor believes would put you at risk or affect the study results.
  • You have had a heart transplant, or a heart transplant is expected in the next 6 months.
  • You are having or are expected to have advanced heart treatments in the next 6 months, such as drip medicines to help the heart pump, planned cardiac resynchronization therapy (a special pacemaker), major surgery, or a mechanical heart pump (ventricular assist device).
  • Your screening blood tests show results that would matter for your health.

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about number of visits, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
332
Started
2026-02-13
Last checked
2026-03

Plain English Summary

What is this study?

  • • Testing a new treatment for symptomatic genetic dilated cardiomyopathy
  • • Phase2/Phase3 - 332 participants
  • • The Sponsor is studying an investigational medication called danicamtiv to determine if it can help people with genetic and familial dilated cardiomyopathy (DCM)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with symptomatic genetic dilated cardiomyopathy

Where?

  • • Bristol - University Hospitals Bristol NHS Foundation Trust
  • • Glasgow - NHS Greater Glasgow and Clyde
  • • Leicester - Glenfield Hospital
  • • London - St. Bartholomew's Hospital
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Symptomatic Genetic Dilated Cardiomyopathy

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Has a diagnosis of DCM due to probable disease-causing variants of MYH7, TTN, or other identified genetic 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...
  • ✓Has a LVEF of ≤45%.
  • ✓Is on stable doses of maximally tolerated standard-of-care heart failure (HF) therapies reflecting current...

Who cannot take part

  • ✗Has heart failure with reduced ejection (HFrEF) caused primarily by ischemic heart disease, chronic valvulopathy, or...
  • ✗Unstable or untreated severe ventricular arrythmia (eg, ventricular tachycardia or ventricular fibrillation).
  • ✗History of cancer of any type within 5 years prior to Screening
  • ✗History of heart transplantation or anticipated heart transplantation in the next 6 months.
  • ✗Clinically significant laboratory abnormalities at Screening
See the full criteria
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

Where Is This Study? (8 UK sites)

University Hospitals Bristol NHS Foundation Trust

Bristol BS1 3NU, United Kingdom

Recruiting
Site contact (verified)
Kardigan Clinical Trial Team1-877-310-5135clinicaltrials@kardigan.bio

NHS Greater Glasgow and Clyde

Glasgow G12 0YN, United Kingdom

Recruiting
Site contact (verified)
Kardigan Clinical Trial Team1-877-310-5135clinicaltrials@kardigan.bio

Glenfield Hospital

Leicester LE3 9QP, United Kingdom

Recruiting
Site contact (verified)
Kardigan Clinical Trial Team1-877-310-5135clinicaltrials@kardigan.bio

St. Bartholomew's Hospital

London EC1A, United Kingdom

Recruiting
Site contact (verified)
Kardigan Clinical Trial Team1-877-310-5135clinicaltrials@kardigan.bio

St George's Hospital

London SW17 0QT, United Kingdom

Recruiting
Site contact (verified)
Kardigan Clinical Trial Team1-877-310-5135clinicaltrials@kardigan.bio

Royal Brompton Hospital

London SW3 6NP, United Kingdom

Recruiting
Site contact (verified)
Kardigan Clinical Trial Team1-877-310-5135clinicaltrials@kardigan.bio

Hammersmith Hospital, Imperial College of London

London W12 0HS, United Kingdom

Recruiting
Site contact (verified)
Kardigan Clinical Trial Team1-877-310-5135clinicaltrials@kardigan.bio

Cardiovascular Clinical Research Facility (CCRF)

Oxford OX3 9DU, United Kingdom

Recruiting
Site contact (verified)
Kardigan Clinical Trial Team1-877-310-5135clinicaltrials@kardigan.bio

How to Get in Touch

Kardigan Clinical Trial Information Team

Sponsor contact

CONTACT

1-877-310-5135 clinicaltrials@kardigan.bio
Data sourced from ClinicalTrials.gov · Last verified: 2026-03