Semaglutide versus diet-based weight loss in obesity and heart failure with reduced ejection fraction (FIT-HF): Protocol for a randomized controlled trial
- Design
- Randomized trial
- Drugs
- Semaglutide
- Assessment
- Not yet reviewed by a person · added Nov 8, 2026
This study was added automatically and has not been reviewed. Until it is, the collection publishes no population match, weight-loss explanation, study tier, findings, population or funding details for it: a check of automatically extracted details found too many errors to show them as fact. The abstract below is the source as retrieved.
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The source, as retrieved
Abstract
[BACKGROUND & AIMS] Obesity is common in heart failure with reduced ejection fraction (HFrEF), but the functional, mechanistic, and safety consequences of intentional weight loss remain uncertain. Incretin-based therapies improve symptoms and functional capacity in obesity-related heart failure with preserved ejection fraction, whereas evidence in HFrEF is limited, and prior glucagon-like peptide-1 receptor agonist trials have raised safety concerns. The FIT-HF trial tests whether semaglutide-based weight loss is superior to intensive diet-based weight loss for improving exercise capacity in adults with obesity and stable HFrEF. [METHODS] FIT-HF is an investigator-initiated, randomized, parallel-group, open-label, assessor-blinded, active-comparator superiority trial enrolling 100 adults with body mass index ≥30 kg/m2, left ventricular ejection fraction ≤40%, New York Heart Association class I-III symptoms, and stable guideline-directed heart failure therapy. Participants are randomized 1:1 to once-weekly subcutaneous semaglutide, titrated to a target dose of 2.4 mg, or low-calorie total dietary replacement of approximately 800 kcal/day for 8 weeks followed by a dietitian-led weight-maintenance program. Both groups receive lifestyle counseling, heart failure care, and structured physical training from week 16. Follow-up is 52 weeks. The primary endpoint is the adjusted between-group difference in change in weight-indexed peak oxygen uptake (VO2peak) from baseline to week 52, assessed by cardiopulmonary exercise testing. Supportive secondary endpoints include Kansas City Cardiomyopathy Questionnaire score, 6-min walk distance, left ventricular end-systolic volume assessed by cardiovascular magnetic resonance, high-sensitivity C-reactive protein, and N-terminal pro-B-type natriuretic peptide. Exploratory work packages assess safety, cardiac/pulmonary physiology, body composition, physical activity, and metabolic/biomarker responses. [DISCUSSION] FIT-HF is the first direct comparison of these weight-loss strategies in obesity and HFrEF, integrating VO2peak with multimodal phenotyping to interpret physiological profiles alongside achieved weight loss and body composition. [CLINICAL TRIAL REGISTRATION] European Clinical Trials Information System: European Union trial number: CT-2023-503753-35-01; ClinicalTrials.gov identifier: NCT06423599.