Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure
Recruiting · NCT06423599 · Interventional (participants receive a specific treatment) · Lead sponsor: Jens D Hove, MD,PHD
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 the composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. These landmark findings have important implications for clinicians -as they mean that weight loss and/or semaglutide as anti-obesity pharmacotherapy could be a treatment strategy for secondary prevention of CV disease in patients with overweight or obesity. It is, however, unknown whether weight loss with either calorie-restricted diet or semaglutide has beneficial effects in obese subjects with heart failure and reduced ejection fraction. Also it is unclear whether semaglutide has cardiovascular benefits irrespective of starting weight and amount of weight loss. Purpose: The study aims to investigate whether weight loss treatment with semaglutide is superior to weight loss with calorie-restricted diet in improving peak oxygen uptake in patients with obesity and heart failure with reduced ejection fraction.
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:
- echocardiography AND/OR
- cardiac magnetic resonance
- On stable optimal medical heart failure therapy for at least 4 weeks
Exclusion criteria
- 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.
- 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
- 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
Where it is running
1 location listed.
- Amager and Hvidovre Hospital University of Copenhagen - Copenhagen, Denmark