Weight Loss for Heart Failure With Reduced Ejection Fraction
Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure
Recruiting
Phase 2
Phase 3
Interventional Study
Heart Failure With Reduced Ejection Fraction
Obesity
Weight Loss
Chronic Heart Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Jens D Hove, MD,PHD · Other
Who this trial is looking for
This trial is looking for adults with obesity and heart failure. Participants will explore how weight loss affects heart health, potentially using a medication called semaglutide.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 18 years old.
- I have a body mass index (BMI) of 30 or higher.
- I have heart failure classified as NYHA class 1-3 and a reduced ejection fraction.
- I have been on stable heart failure medication for at least 4 weeks.
You may not be able to join if
- I have had a heart attack, stroke, or unstable angina in the past 6 months.
- I have planned heart surgery or revascularization.
- I have type 1 diabetes.
- I have been treated with GLP-1 agonists in the past 90 days.
- I am currently pregnant or planning to become pregnant.
- I have chronic pancreatitis.
- I have kidney disease with an eGFR lower than 35.
- I have a history of cancer in the past 5 years, except for certain skin cancers.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 demons…
Trial Locations
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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 m…
Contacts