The Effects of Obesity and Weight Loss in Heart Failure: Imaging the Obesity Paradox Using Magnetic Resonance Imaging and Spectroscopy - Heart Failure With Reduced Ejection Fraction Substudy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Left ventricular ejection fraction
研究概览
简要总结
This study looks at the effects of weight loss in people who have heart failure with reduced ejection fraction (HFpEF) and are overweight or obese.
The main questions it aims to answer are whether weight loss in this group of people improves:
- The heart's shape and how well it pumps blood
- The person's quality of life and how much they can exercise
Participants will attend 2 study visits, separated by 3-6 months. The intervention period takes place in between the 2 study visits.
Each study visit may involve measurements including:
Symptom and quality of life questionnaires Body measurements such as height and weight Blood tests Ultrasound scans of the heart (echocardiogram) Magnetic Resonance Imaging (MRI) scans of the heart 6 minute walk test Participants are randomly allocated (in other words, by lottery) to either 'diet' or 'control' groups. The control group will continue standard care.
The diet group will be enrolled in a weight loss program supervised by the study team. Participants in the diet group will replace their usual meals with meal replacement products specifically designed to deliver a low calorie diet for weight loss. The products will consist of formula soups, shakes and porridges. This diet would last 8 weeks, followed by a guided period of food reintroduction and maintenance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart failure determined by left ventricular ejection fraction 20-45%
- •Body mass index > 27.5kg/m^2
排除标准
- •Contraindications to magnetic resonance imaging
- •NYHA class IV
- •Pregnancy, planned pregnancy or lactating
- •Significant valvular, ischemic, infiltrative or other potentially confounding cardiac disease
- •Any other conditions which may potentially compromise the safety or scientific validity of the study
结局指标
主要结局
Left ventricular ejection fraction
时间窗: Change from baseline at 3-6 months
On cardiac magnetic resonance imaging (CMR)
次要结局
- Six minute walk distance(Change from baseline at 3-6 months)
- Body weight(Change from baseline at 3-6 months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(Change from baseline at 3-6 months)
- N-terminal pro brain natriuretic peptide (NTproBNP)(Change from baseline at 3-6 months)