Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 18 Years to no upper limit; excludes diabetes; BMI ≥30 required; conditions: Heart Failure With Reduced Ejection Fraction; Obesity; Weight Loss; Chronic Heart Failure
- Interventions
- Semaglutide Injectable Product; Calorie-restricted diet
- Conditions
- Heart Failure With Reduced Ejection Fraction; Obesity; Weight Loss; Chronic Heart Failure
- Phase and size
- Phase 2, Phase 3 · 100 participants
- Dates
- Start 2024-04-30
Primary completion 2027-12-30 - Sponsor
- Jens D Hove, MD,PHD (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Peak oxygen uptakeThe patients will be examined after 0, 16 and 52 weeks
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.