Key result
Trial tests semaglutide versus intensive diet for exercise capacity in obese HFrEF.
Why the study?
Does semaglutide-based weight loss improve exercise capacity compared to intensive diet-based weight loss in adults with obesity and stable HFrEF?
RCT (n=100)
Open-label, assessor-blinded
Randomized, parallel-group
Does semaglutide-based weight loss improve exercise capacity compared to intensive diet-based weight loss in adults with obesity and stable HFrEF?
This trial protocol describes the first direct randomized comparison of semaglutide-based versus intensive diet-based weight loss on exercise capacity in patients with obesity and stable HFrEF.
Answers are grounded in this paper and cite their sources.
No practice change yet for obese HFrEF; this first RCT will extend evidence on semaglutide versus diet for exercise capacity.
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/m DISCUSSION: FIT-HF is the first direct comparison of these weight-loss strategies in obesity and HFrEF, integrating VO CLINICAL TRIAL REGISTRATION: European Clinical Trials Information System: European Union trial number: CT-2023-503753-35-01; ClinicalTrials.gov identifier: NCT06423599.
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El‐Sheikh et al. (2026) conducted an RCT in Obesity and heart failure with reduced ejection fraction (HFrEF) (n=100). Semaglutide-based weight loss vs. Intensive diet-based weight loss was evaluated on Exercise capacity. Semaglutide-based weight loss is being tested for superiority over intensive diet-based weight loss for exercise capacity in 100 adults with BMI ≥30 kg/m² and HFrEF (protocol; no results yet).
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