Phase 3 Cardiomyopathy Trial, Recruiting NCT06128980 Sponsor: Herlev and Gentofte Hospital Condition: Cardiomyopathy
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Phase 3 Cardiomyopathy Trial, Recruiting

NCT06128980
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:

  • You have been newly diagnosed with heart failure (either as an outpatient or during a hospital stay) where the heart is not pumping as strongly as it should (the pumping function is 40% or less on an ultrasound of the heart)
  • You have moderate to severe heart failure symptoms affecting your daily life
  • You have an irregular heart rhythm called atrial fibrillation or atrial flutter, where your heart rate was running at 110 beats per minute or higher
  • After receiving standard treatment, your irregular heart rhythm was either corrected or brought under control (heart rate below 110 at rest)
  • Following that treatment, your heart's pumping function recovered to 50% or above, your heart size returned to normal on ultrasound, your heart tracing (ECG) returned to normal, and a specific heart stress marker in your blood (NT-proBNP) dropped below 250 pg/ml

Who may not be able to join:

  • People under 18 years of age or those who are unable to give their own consent
  • People who have previously had a heart ablation procedure and cannot take rhythm-controlling medications
  • People who are pregnant
  • People with certain heart defects present from birth (minor defects that don't affect blood flow may still be eligible — confirm with trial site)
  • People who have already been tested and found to carry a gene linked to heart muscle disease
  • People likely to have specific types of heart muscle disease, such as thickened, stiff, or spongy heart muscle
  • People with moderate or severe problems with their heart valves
  • People with known or suspected build-up of abnormal proteins or inflammatory conditions affecting the heart (such as amyloidosis or sarcoidosis)
  • People with a high number of extra irregular heartbeats (more than 10% of all heartbeats) or a history of dangerous fast heart rhythms
  • People who had a long-term or permanent fast irregular heart rhythm (above 110 bpm) before their heart failure was diagnosed, even with the best treatment available
  • People with significantly reduced kidney function (confirm with trial site)
  • People who had a heart attack at the time of their heart failure diagnosis
  • People whose atrial fibrillation or heart failure was likely caused by medications, alcohol, or recreational drug use
  • People with consistently very high blood pressure (above 160 mmHg on multiple readings) or a history of blood pressure that could not be controlled
  • People with inflammation of the heart muscle (myocarditis)
  • People who were in a state of severe heart failure shock at the time of diagnosis
  • People who survived a sudden cardiac arrest
  • People whose heart muscle weakening was caused by an artificial pacemaker
  • People who have a parent, child, or sibling diagnosed with a specific type of weakened heart muscle condition called dilated cardiomyopathy

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 27 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

Principal Investigator: Emil Wolsk, MD, Herlev and Gentofte Hospital

Phone: +4538683868

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
Herlev and Gentofte Hospital
Registry
ClinicalTrials.gov
Start date
9 January 2025
Est. completion
1 January 2028

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

Patients free from heart failure deterioration 1 year after randomization

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: 27 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