Cardiomyopathy Trial, Recruiting NCT06747429 Sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III Condition: Cardiomyopathy
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Cardiomyopathy Trial, Recruiting

NCT06747429
Recruiting Not Applicable

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:

  • Adults aged 18 or older, of any sex.
  • People who have been diagnosed with heart failure caused by a condition called non-ischemic dilated cardiomyopathy (a type of weakened, enlarged heart not caused by blocked arteries), with or without a known genetic cause.
  • People whose heart pumping function, as measured by a cardiac MRI scan, shows the heart is pumping at 49% or less of its normal capacity.
  • People who have been on a stable, optimised heart failure medication plan for at least 3 months before joining the trial.
  • People who have given their informed consent to participate.

Who may not be able to join:

  • People who have previously been diagnosed with heart failure caused by blocked heart arteries (ischemic dilated cardiomyopathy).
  • People who have a prior diagnosis of established cardiovascular disease related to fatty buildup in the arteries, such as chest pain (angina), heart attack, mini-stroke or stroke, or poor blood flow to the legs or other areas of the body.
  • People whose heart failure medications have been changed in the last 3 months.
  • People who have had a worsening of their heart failure in the past 3 months, including a hospital stay for heart failure or the need for intravenous fluid or heart-support treatments given in a clinic.
  • People with poorly controlled cholesterol or triglyceride (blood fat) levels that remain above certain thresholds despite treatment.
  • People who cannot safely have a cardiac MRI scan — for example, due to severe claustrophobia (fear of enclosed spaces), or because they have a medical device in their body that is not safe in MRI environments, such as a pacemaker, an implanted heart defibrillator, or a cardiac resynchronisation device.
  • People who have a diagnosed liver or bile duct condition, including non-alcoholic fatty liver disease or gallstones that have not been surgically treated.
  • People who have a history of acute or chronic pancreatitis (inflammation of the pancreas).
  • People with a known allergy to fish or nuts.
  • People whose life expectancy is estimated to be less than 12 months.
  • People who are pregnant, or planning to become pregnant in the next 4 months.
  • People who are currently breastfeeding.
  • People who are already taking part in another randomised clinical trial.
  • People who are unable to give consent or to attend the required follow-up visits for the study.

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
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Francesco Sofi, MD PhD, University of Florence, Clinical and Experimental Medicine, Unit of Clinical Nutrition, Florence,

Phone: (+34) 914531200

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
Not Applicable
Sponsor
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Registry
ClinicalTrials.gov
Start date
15 January 2026
Est. completion
1 June 2026

Where this trial is recruiting

🇫🇷 France 🇮🇹 Italy 🇷🇴 Romania 🇪🇸 Spain

Primary endpoints

Changes in left ventricular ejection fraction (LVEF)

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