NCT06423599 Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure
| NCT ID | NCT06423599 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Jens D Hove, MD,PHD |
| Condition | Heart Failure With Reduced Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-04-30 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-04-30 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Jens D Hove
PRINCIPAL INVESTIGATOR
Amager-Hvidovre Universitetshospital
Frequently Asked Questions
Who can join the NCT06423599 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure With Reduced Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06423599 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06423599 currently recruiting?
Yes, NCT06423599 is actively recruiting participants. Contact the research team at jens.dahlgaard.hove@regionh.dk for enrollment information.
Where is the NCT06423599 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT06423599 clinical trial?
NCT06423599 is sponsored by Jens D Hove, MD,PHD. The principal investigator is Jens D Hove at Amager-Hvidovre Universitetshospital. The trial plans to enroll 100 participants.
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