2023-503753-35-01招募中2 期
FIT-HF - Effect of weight loss on physical and cardiac performance in patients with heart failure and obesity
Region Hovedstaden, Region Hovedstaden1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年2月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary endpoint is change in peak oxygen uptake per kg per min (Vo2max) at 52 weeks between groups.
研究概览
简要总结
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.
研究设计
- 分配方式
- Randomized
- 主要目的
- Fit-hf : Effect Of Weight Loss On Physical And Cardiac Performance In Obese Heart Failure Patients
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Cardiovascular-related:
- •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
- •Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- •Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
- •Transient tachycardic induced heart failure
- •Glycaemia-related:
- •History of type 1 diabetes
- •Treatment with any GLP-1 RA within 90 days before screening
- •Type 2 diabetes and treatment other than metformin or SGLT-2 inhibitor
- •General safety:
- •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
- •Severe psychiatric disorder which in the investigator’s opinion could compromise compliance with the protocol
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Previous participation in this trial. Participation is defined as randomisation
- •Receipt of any investigational medicinal product within 30 days before screening
- •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
- •Any disorder, unwillingness or inability, which in the investigator’s opinion, might jeopardise the subject’s safety or compliance with the protocol
结局指标
主要结局
The primary endpoint is change in peak oxygen uptake per kg per min (Vo2max) at 52 weeks between groups.
The primary endpoint is change in peak oxygen uptake per kg per min (Vo2max) at 52 weeks between groups.
次要结局
- • To compare the effect of weight loss on quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ). • To compare the effect of weight loss on the 6MWD • To compare the effect of weight loss on the end-systolic volume assessed by Cardiac MR • To compare the effect of weight loss on the change in biomarkers as high-sensitivity CRP and pro-BNP • Feasibility and safety of a modern weight loss program for weight lowering in high-risk symptomatic patients.
研究者
Jens Dahlgaard Hove
Scientific
Hvidovre Hospital
研究点 (1)
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