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FIT-HF - Effect of weight loss on physical and cardiac performance in patients with heart failure and obesity
EU CTIS ID: 2023-503753-35-01
What this study is testing
To examine whether weight loss with semaglutide is superior to weight loss with calorie restricted diet in improving the peak oxygen uptake as a marker of physical performance (and with prognostic implications) in patients with obesity and heart failure with reduced EF.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Age>18 years at the time of inclusion
- Body mass index (BMI) ≥ 30 kg/m2
- Have heart failure with reduced ejection fraction (EF<=40%) established by: a. echocardiography b. cardiac magnetic resonance
- Being on stable optimal-medical-heart failure treatment for 4 weeks.
You likely can't join if
- Cardiovascular-related: 1. Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening 2. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening 3. Presently classified as being in New York Heart Association (NYHA) Class IV heart failure 4. Transient tachycardic induced heart failure
- Glycaemia-related: 5. History of type 1 diabetes 6. Treatment with any GLP-1 RA within 90 days before screening 7. Type 2 diabetes and treatment other than metformin or SGLT-2 inhibitor
- General safety: 8. History or presence of chronic pancreatitis 9. Presence of acute pancreatitis within the past 180 days prior to the day of screening 10. Kidney disease with eGFR<35ml/min 11. 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 12. Severe psychiatric disorder which in the investigator’s opinion could compromise compliance with the protocol 13. Known or suspected hypersensitivity to trial product(s) or related products 14. Previous participation in this trial. Participation is defined as randomisation 15. Receipt of any investigational medicinal product within 30 days before screening 16. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method 17. Any disorder, unwillingness or inability, which in the investigator’s opinion, might jeopardise the subject’s safety or compliance with the protocol
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.