Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJens D Hove, MD,PHD
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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, age ≥ 18 years at the time of signing informed consent
Body mass index (BMI) ≥ 30 kg/m2
echocardiography AND/OR
cardiac magnetic resonance
Disqualifiers
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.
Type 1 diabetes
Trial design
Design model
Parallel
Treatments tested in this trial
Semaglutide Injectable Product
DrugWeight loss using Semaglutide
Calorie-restricted diet
Dietary supplementWeight loss by calorie-restricted diet program followed by a weight loss maintenance follow-up program
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Semaglutide intervention groupExperimental treatment 1 intervention
Group B: Calorie-restricted diet intervention groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Peak oxygen uptake
To examine the effect of weight loss on mean change in peak oxygen uptake at 52 weeks between semaglutide and calorie-restricted group compared to baseline (Measured in ml O2/(kg x min))
Time frame
The patients will be examined after 0, 16 and 52 weeksSecondary outcomes
1
The Clinical Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-CSS)
To compare the effect of weight loss on the mean change
Time frame
The patients will be examined after 0, 16 and 52 weeks.2
6-min walk distance (6MWD)
To compare the effect of weight loss on the mean change
Time frame
The patients will be examined after 0, 16 and 52 weeks3
End-systolic volume of the left ventricle assessed by Cardiac MRI
To compare the effect of weight loss on the mean change
Time frame
The patients will be examined after 0, 16 and 52 weeks4
N-terminal pro-B-type natriuretic peptide (NT-proBNP) and C-reactive protein (CRP) change
To compare the effect of weight loss on the mean change
Time frame
The patients will be examined after 0, 16 and 52 weeksOther outcomes
1
Composite endpoint consisting of all-cause death, non-fatal myocardial infarction, non-fatal stroke, heart failure hospitalisation or urgent heart failure visit
Time frame
Follow-up at 52 weeks2
First occurrence of a composite heart failure endpoint consisting of: heart failure hospitalisation, urgent heart failure visit, ischemic events or CV death
Time frame
Follow-up at 52 weeks3
All-cause death
Time frame
Follow-up at 52 weeks4
Total number of hospitalised days
Time frame
Follow-up at 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jens D Hove, MD,PHD
Lead sponsor
Hvidovre University Hospital
Sponsor institution
Source ClinicalTrials.gov