FIT-HF - Effect of weight loss on physical and cardiac performance in patients with heart failure and obesity

Phase 1

• Conditions: Obesity and Heart Failure with reduced Ejection Fracition; MedDRA version: 20.0Level: LLTClassification code: 10078289Term: Heart failure with reduced ejection fraction Class: 10007541; MedDRA version: 20.0Level: PTClassification code: 10029883Term: Obesity Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-503753-35-01
• Lead Sponsor: Hvidovre Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-29
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified