Impact of weight loss on heart function in obese patients with heart failure
Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure
This study is testing if losing weight with the help of a medication and a special diet can improve heart function and quality of life for obese patients with heart failure.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hvidovre University Hospital Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06423599 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of weight loss on physical and cardiac performance in individuals suffering from obesity and heart failure with reduced ejection fraction (HFrEF). Participants will receive semaglutide, an injectable medication, alongside a calorie-restricted diet to facilitate weight loss. The study aims to evaluate improvements in cardiovascular health and overall quality of life, building on previous findings that suggest weight loss can significantly benefit heart failure patients. The trial will include individuals who are on stable heart failure therapy and meet specific eligibility criteria related to their health status.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a BMI of 30 kg/m2 or higher and diagnosed with heart failure with reduced ejection fraction.
Not a fit: Patients with type 1 diabetes or those who have recently used GLP-1 agonists may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart function and quality of life for patients with obesity and heart failure.
How similar studies have performed: Previous studies have shown promising results with similar approaches, particularly in the context of weight loss and cardiovascular health.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Copenhagen
- Amager and Hvidovre Hospital University of Copenhagen — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Jens D Hove — Amager-Hvidovre Universitetshospital
- Study coordinator: Jens D Hove, MD, PhD
- Email: jens.dahlgaard.hove@regionh.dk
- Phone: +4538623218
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.