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

Launched by JENS D HOVE, MD,PHD · May 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of weight loss on heart and physical performance in people who are obese and have heart failure with reduced ejection fraction (HFrEF). The trial will compare two methods of weight loss: one using a medication called semaglutide, which has shown promise in helping with weight loss and improving heart health, and the other using a calorie-restricted diet. The goal is to see if using semaglutide is better for improving physical fitness and heart function compared to just dieting.

To be eligible for this trial, participants must be at least 18 years old, have a body mass index (BMI) of 30 or higher, and have been diagnosed with heart failure that meets certain criteria. They should also be stable on their heart failure medications for at least four weeks. Participants will be closely monitored and can expect regular check-ins to assess their health and progress. It's important to know that some individuals, such as those with certain heart conditions or diabetes, may not qualify for the study.

Gender

ALL

Eligibility criteria

• 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