The Effects of Obesity and Weight Loss in Heart Failure: Imaging the Obesity Paradox Using Magnetic Resonance Imaging and Spectroscopy - Heart Failure With Preserved Ejection Fraction Substudy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Left atrial volume
研究概览
简要总结
This study looks at the effects of weight loss in people who have heart failure with preserved 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, how well it pumps blood and how well it uses fuels
- 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 will 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
- Exercise components during the scans
- 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.
详细描述
An interim analysis is planned at 60 recruits to review the recruitment target.
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 with preserved ejection fraction (HFpEF)
- •Left ventricular ejection fraction (LVEF) =/> 50%
- •Body Mass Index (BMI) approximately =/> 27.5 kg/m^2
排除标准
- •Contraindications to magnetic resonance imaging
- •NYHA class IV
- •Significant valvular, ischemic, infiltrative or other potentially confounding cardiac disease
- •Pregnancy, planned pregnancy or lactating
- •Any other conditions which may potentially compromise the safety or scientific validity of the study
结局指标
主要结局
Left atrial volume
时间窗: Change from baseline at 3-6 months
measured on cardiac magnetic resonance imaging
次要结局
- Body weight(Change from baseline at 3-6 months)
- Six minute walk distance(Change from baseline at 3-6 months)
- N-terminal pro brain natriuretic peptide (NT pro BNP)(Change from baseline at 3-6 months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(Change from baseline at 3-6 months)