Phase 3 Cardiomyopathy Trial, Recruiting NCT07210723 Sponsor: Kardigan, Inc. Condition: Cardiomyopathy
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Phase 3 Cardiomyopathy Trial, Recruiting

NCT07210723
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with dilated cardiomyopathy (an enlarged, weakened heart) linked to specific genetic variants (in genes called MYH7, TTN, or similar), or where the condition runs in the family
  • People whose heart failure symptoms fall into a moderate-to-severe range (Class II to IV on a standard medical scale) and whose symptoms have been stable for at least one month before the screening visit
  • People whose heart has at least mild enlargement of the left chamber, and whose heart can be clearly seen on an ultrasound scan
  • People whose heart's pumping strength (called ejection fraction) is 45% or below
  • People who have been on the highest doses of standard heart failure medications they can tolerate, and those doses have been stable for at least four weeks before the first visit
  • People whose enlarged, weakened heart is not caused by substance use, or by conditions such as amyloidosis, sarcoidosis, or other secondary causes
  • People who are able to complete an upright exercise breathing test, and whose oxygen uptake during peak effort is 80% or less of what would be expected for a healthy person of the same profile, with sufficient effort shown during the test (confirm with trial site)

Who may not be able to join:

  • People whose weakened heart is caused mainly by blocked coronary arteries, long-term heart valve disease, or another underlying condition, as determined by the treating investigator
  • People who have had a significant heart event in the past 90 days, such as a heart attack, a procedure to open blocked heart arteries, heart bypass surgery, or a hospital stay related to heart failure or fluid-removal treatment given through a drip
  • People who have certain heart rhythm problems that could interfere with accurate heart ultrasound readings, such as poorly controlled atrial fibrillation or irregular heartbeats occurring frequently enough to affect measurements
  • People who have an unstable or untreated serious abnormal heart rhythm, such as ventricular tachycardia or ventricular fibrillation
  • People who have been diagnosed with any type of cancer within the five years before the screening visit
  • People with severely reduced kidney function, as measured by a specific blood test result falling below a set threshold at the time of screening
  • People who have any other significant medical condition, disorder, or disease that, in the investigator's or sponsor's opinion, could affect safety or interfere with the study
  • People who have previously had a heart transplant, or for whom a heart transplant is expected within the next six months
  • People who are currently receiving, or are expected to need, advanced heart treatments such as long-term heart-strengthening medication given through a drip, heart device implantation, resynchronisation therapy, or major surgery within six months
  • People who have significantly abnormal blood test results at the time of screening

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 1-877-310-5135

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Kardigan, Inc.
Registry
ClinicalTrials.gov
Start date
13 February 2026
Est. completion
1 September 2027

Where this trial is recruiting

🇧🇪 Belgium 🇩🇰 Denmark 🇫🇷 France 🇭🇺 Hungary 🇮🇹 Italy 🇳🇱 Netherlands 🇵🇱 Poland 🇪🇸 Spain 🇸🇪 Sweden 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Part 1: Change from Baseline (Day 1) to Week 26 in left atrial function index in Cohort 1; Part 2: Change from Baseline (Day 1) to Week 26 in peak VO2 in Cohort 1

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov