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High Fat Diet for Cardiac Metabolic Reprogramming

RecruitingNAAges 18 Years - anyAllFundación Centro Nacional de Investigaciones Card…
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In plain words

What the trial is, and whether it could suit you

Heart failure (HF) continues to be a leading cause of morbidity and mortality worldwide, despite advances in treatment. HF is often characterized by an altered metabolism in the heart, where glucose is favored over fatty acids as the primary energy substrate. This metabolic shift has been hypothesized to contribute to disease progression. Previous studies using animal models have demonstrated that restoring fatty acid metabolism through dietary intervention can reverse the adverse metabolic effects and improve heart function. A transgenic murine model with mitochondrial defects, for instance, exhibited improved cardiac function after an HFD intervention. These findings were reinforced by a translational pig model of non-ischemic DCM, where a high-fat diet significantly improved LVEF compared to a standard diet. Building upon these promising preclinical results, a small-scale human study

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📋 Eligibility rules (as published)
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
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What it tests

  • High fat diet
  • Standard diet
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Where

5 sites
Hôpital Européen Georges Pompidou, INSERM
Paris, France
University of Florence, Clinical and Experimental Medicine, Unit of Clinical Nutrition,
Florence, Italy
University of Medicine and Pharmacy "Carol Davila", Bucharest,
Bucharest, Romania
Fundación Investigación Biomédica Hospital Universitario Puerta de Hierro (IIS),
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz,
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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