Impact of weight loss on heart function in obese patients with heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.