Tests a high fat diet in people with heart failure from weakened heart muscle
Tests a high fat diet against standard diet in adults with dilated cardiomyopathy.
Plain-language title generated from the registry record
Registry title: High Fat Diet for Cardiac Metabolic Reprogramming
Key facts
- Where
- Madrid, SpainSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with heart failure caused by non-ischemic dilated cardiomyopathy and a reduced heart pumping ability. It tests a high-fat diet against a standard diet.
- Age
- 18 years or older
- Sex
- Both sexes can join
- Disease stage
- Heart failure from non-ischemic dilated cardiomyopathy, with LVEF of 49% or lower on the baseline cardiac MRI (CMR)
- Earlier treatment
- Must have been on optimized guideline-directed heart failure medicine for at least 3 months before joining
Main reasons for not taking part
- Ischemic cardiomyopathy or established atherosclerotic cardiovascular disease
- Change in heart failure treatment or worsening of heart failure in the last 3 months
- Uncontrolled high blood fats (LDL-cholesterol above 160 mg/dL (4.1 mmol/L) and/or triglycerides above 200 mg/dL (2.3 mmol/L))
- Pacemaker, cardiac defibrillator or cardiac resynchronization device, or other reason that rules out cardiac MRI
- Liver or bile disease, pancreatitis, fish or nut allergy, pregnancy or breastfeeding
Read by machine on 12 November 2026.
Where in Spain
- Fundación Investigación Biomédica Hospital Universitario Puerta de Hierro (IIS),Madrid, SpainContact: Pablo García Pavía, MD PhDTaking people
- Hospital Universitario Fundación Jiménez DíazMadrid, SpainContact: Mikel Taibo Urquía, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
- Trial code
- NCT06747429
- Record updated
- 26 May 2026
- Original description
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.Read full original descriptionShow less
Cardiac Metabolic Reprogramming by a Nutritional Intervention: the High Fat Diet for Heart Failure (HF4HF) Study, a proof-of Concept Randomized Controlled Trial
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 showed that lipid infusion, rather than glucose, improved cardiac function in HF patients. However, the long-term benefits of a HFD in heart failure patients have yet to be thoroughly explored. The HF4HF trial aims to fill this gap by evaluating the effects of an HFD over a two-month period in patients with non-ischemic DCM and reduced LVEF.
The "High Fat Diet for Heart Failure" (HF4HF) study is a proof-of-concept randomized controlled trial designed to investigate the efficacy of a high-fat diet (HFD) as a therapeutic intervention in patients with non-ischemic dilated cardiomyopathy (DCM) and reduced left ventricular ejection fraction (LVEF). The study hypothesizes that cardiac metabolic reprogramming, achieved through a controlled nutritional intervention involving an HFD, can enhance systolic function, myocardial energetics, and overall heart function in heart failure (HF) patients. Cofunded by the European Commission and national entities, the trial is spearheaded by a consortium of cardiovascular research centers across four countries: Spain, Italy, France, and Romania.
Inclusion: 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: 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; 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; 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; Uncontrolled dyslipidemia, defined as LDL-cholesterol >160 mg/dL and/or triglycerides >200 mg/dL, despite treatment; 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.