High-fat diet for heart metabolism in non-ischemic dilated cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates whether increasing dietary fat intake can shift heart energy use back toward fatty acids in patients with non-ischemic dilated cardiomyopathy and heart failure with reduced ejection fraction. Eligible participants are adults with confirmed non-ischemic DCM, LVEF ≤49%, and stable guideline-directed therapy for at least 3 months. Participants will be assigned to a high-fat diet or a standard diet to assess effects on cardiac function and related metabolic parameters. The study builds on preclinical data suggesting metabolic remodeling with high-fat intake may improve myocardial function in this condition. Safety monitoring and exclusion criteria are in place to minimize risks related to lipid levels and heart failure stability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients of both sexes and ≥18 years old
* Patients diagnosed with HF secondary to non-ischemic DCM, according to ESC guidelines definition,1 with or without a known genetic basis.
* LVEF ≤49% according to the baseline CMR.
* Optimized HF guideline-directed medical therapy for at least 3 months prior to inclusion.
* Patients who have provided informed consent.

Exclusion Criteria:

* Prior diagnosis of ischemic DCM.
* Prior diagnosis of established atherosclerotic cardiovascular disease (angina/myocardial infarction, transient ischemic attack/stroke, lower limb ischemia or at any other peripheral level).
* Changes in HF therapies within the last 3 months.
* HF decompensation within the previous 3 months, including HF hospitalization or the need of ambulatory intravenous diuretic or inotropic treatment such as levosimendan.
* Uncontrolled dyslipidemia, defined as LDL-cholesterol \>160 mg/dL and/or triglycerides \>200 mg/dL, despite treatment.
* Any contraindication for CMR:

Severe claustrophobia. Any device which is known to threaten or pose hazard in all MR environments. //www.mrisafety.com/ Patients with implanted biomedical devices (cardiac artefacts): pacemakers, cardiac defibrillators or cardiac resynchronization therapy.

* Liver and biliary diseases, including prior diagnosis of non-alcoholic fatty liver disease and unoperated cholelithiasis.
* Prior episodes of acute pancreatitis or chronic pancreatitis.
* Prior fish or nut allergy.
* Life expectancy less than 12 months.
* Pregnancy or planned pregnancy for the next 4 months.
* Current lactation.
* Patients participating in other randomized clinical trial.
* Impossibility to consent or undergo study follow-up

Where it's running

• University of Medicine and Pharmacy "Carol Davila", Bucharest,
  Bucharest, Romania Recruiting
• Fundación Investigación Biomédica Hospital Universitario Puerta de Hierro (IIS),
  Madrid, Spain Recruiting
• Hospital Universitario Fundación Jiménez Díaz,
  Madrid, Spain Recruiting
• Hôpital Européen Georges Pompidou, INSERM
  Paris, France Not yet recruiting
• University of Florence, Clinical and Experimental Medicine, Unit of Clinical Nutrition,
  Florence, Italy Not yet recruiting

Study contacts

• Principal investigator: Francesco Sofi, MD PhD — University of Florence, Clinical and Experimental Medicine, Unit of Clinical Nutrition, Florence,
• Study coordinator: Carlos Nicolás Pérez-García, MD PhD.
• Email: carlosnicolas.perez@cnic.es
• Phone: (+34) 914531200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.