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Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllJens D Hove, MD,PHD
NCT06423599 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The benefit of weight loss in patients with obesity and heart failure with reduced ejection fraction (HFrEF) is controversial. Semaglutide has shown cardiovascular (CV) risk-reduction and impact on CV risk factors including overweight, dysglycaemia and hypertension in subjects with type 2 diabetes (T2D). The STEP-HFpEF (Semaglutide Treatment Effect in People With Obesity and HFpEF) recently demonstrated, at 1-year, to not only reduce weight considerably, but also significantly improve health-related quality of life, functional status scores and 6-min walk distance in patients with heart failure with preserved ejection fraction (HFpEF). Also, the recently concluded SELECT trial was the first CV outcome trial with semaglutide in patients with overweight or obesity and established CV disease, including heart failure (but no T2D). Semaglutide demonstrated a 20% reduction in MACE, defined as

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male or female, age ≥ 18 years at the time of signing informed consent * Body mass index (BMI) ≥ 30 kg/m2 * Heart failure with New York Heart Association (NYHA)-class 1-3 and reduced ejection fraction (EF≤40%) established by either: 1. echocardiography AND/OR 2. cardiac magnetic resonance * On stable optimal medical heart failure therapy for at least 4 weeks Exclusion Criteria: 1. Cardiovascular-related: * Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 6 months prior to the day of screening * Planned coronary, carotid or peripheral artery revascularisation known on the day of screening * Transient heart failure related to reversible mechanisms like tachycardia, sepsis, etc. 2. Glycaemia-related: * Type 1 diabetes * Treatment with any Glucagon-Like Peptide-1 (GLP-1) agonists within 90 days prior to the day of screening * Type 2 diabetes requiring other pharmacotherapy than metformin and Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors 3. General safety: * Pregnancy or planned pregnancy * History or presence of chronic pancreatitis * Presence of acute pancreatitis within the past 180 days prior to the day of screening * Kidney disease with eGFR \< 35ml/min * Presence or history of malignant neoplasms within the past 5 years prior to the day of screening (Basal and squamous cell skin cancer and any carcinoma in-situ are allowed) * Known or suspected hypersensitivity to trial product(s) or related products
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What it tests

  • Semaglutide Injectable Product
  • Calorie-restricted diet
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Where

1 site
Amager and Hvidovre Hospital University of Copenhagen
Copenhagen, Denmark
🤝 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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