A Multi-Ethnic, Multi-centre raNdomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction (AMEND-preserved)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 6
- 主要终点
- Change in the distance walked during 6 minute walk test (6MWT)
研究概览
简要总结
Heart failure with preserved ejection fraction (HFpEF) is a common and serious complication of obesity and type 2 diabetes (T2D). HFpEF occurs when the heart muscle unable to relax efficiently to pump the blood around the body. This leads to fluid build-up, breathlessness and inability to tolerate physical exertion. People who develop HFpEF do less well because treatment options are limited. Pilot data in patients with obesity and diabetes and a small number of patients with HFpEF have shown improvements in exercise capacity and reversal of changes in the heart and blood vessels. This study will assess if this is achievable in a multi-ethnic cohort of patients with established HFpEF. A total of 63 adults will be invited and allocate by chance into two groups: 1) 12-weeks of a low calorie diet or 2) Standard care and health advice on how to lose weight followed by the option to have the low calorie diet after 12-weeks. The study will determine if weight loss over 12 weeks can improve heart function, symptoms and ability to exercise. Additionally, participants' views on changing their diet and how this has impacted their symptoms will be sought during the study in an optional interview. This will help guide treatments planning in the future to get maximum benefits, and to individualize support to patients from different cultural backgrounds.
详细描述
Heart failure (HF) with preserved ejection fraction (HFpEF) is a heterogenous syndrome, typified by severe exercise intolerance and with limited treatment options. Weight loss achieved through a low energy meal-replacement plan (MRP) has been shown to lead to reversal of cardiovascular remodelling in ethnically diverse asymptomatic adults with pre-HFpEF and HFpEF. This trial will translate this experience with the pragmatic low energy MRP into a symptomatic, multi-ethnic cohort of obese HFpEF, across four sites (Leicester, Manchester, Leeds and Oxford) to assess its efficacy in improving exercise intolerance, symptoms, quality of life, cardiovascular remodelling, and skeletal myopathy.
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
- None
盲法说明
Participants and investigator will not be blinded to treatment allocation (open label) however, the team analysing the outcomes, where possible, will be blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established clinical diagnosis of heart failure with preserved ejection fraction HFpEF (EF>45%) made by a cardiologist or a primary care physician with heart failure expertise, or a heart failure nurse
- •Clinically stable for ≥ 3 months (no admissions to hospital)
- •Obesity (BMI ≥30kg/m2 if white European or ≥27kg/m2 if Asian, Middle Eastern or Black ethnicity)
排除标准
- •Inability to walk/undertake 6-minute walk test
- •Inability to follow a low-energy MRP
- •HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy/pericardial disease or congenital heart disease.
- •Recovered EF (previous EF < 40%) unless reduced EF was in context of tachycardia induced cardiomyopathy (eg AF/Aflutter).
- •Known heritable, idiopathic or drug-induced pulmonary arterial hypertension
- •Severe chronic obstructive pulmonary disease (FEV1< 1.0L)
- •Severe primary valvular heart disease
- •Anaemia (Hb<100g/L)
- •Severe renal disease (eGFR < 30 ml/min/1.73 m2)
- •Weight loss > 5kg in preceding 3 months.
- •Symptomatic gallstones (including biliary colic) or cholecystitis within last 3 months
- •Active substance abuse (drugs or alcohol)
- •History of bariatric surgery in the last 3 years
- •Active illness likely to cause change in weight
- •Women who are pregnant or are considering pregnancy
- •People currently participating in another clinical research trial that is likely to affect diet or weight change.
- •History of a severe mental illness including an eating disorder
- •17. Individuals with a diagnosis of Type 1 diabetes mellitus.
研究组 & 干预措施
Low calorie meal replacement plan (MRP) arm
The MRP comprises of 3-4 meals a day (850kcal/day) supplied by Counterweight. Participants will be supported by professional research dieticians, and a study clinician. Participant health and medications will be monitored throughout the study.
Offered to the comparator arm after 12 weeks as a control participant.
干预措施: Electrocardiogram (Diagnostic Test)
Low calorie meal replacement plan (MRP) arm
The MRP comprises of 3-4 meals a day (850kcal/day) supplied by Counterweight. Participants will be supported by professional research dieticians, and a study clinician. Participant health and medications will be monitored throughout the study.
Offered to the comparator arm after 12 weeks as a control participant.
干预措施: Accelerometery (Diagnostic Test)
Wait list control arm: Guideline driven care with attention control arm followed by optional MRP
Dietary advice to participants will be given in line with NICE guidelines for cardiovascular risk modification. Heart failure specific advice on exercise will be given in line with guidelines. After 12 weeks as a control participant, these individuals will then have the option to receive the meal replacement plan and repeat assessments after a further 12 weeks.
干预措施: Assessment of frailty (Other)
Low calorie meal replacement plan (MRP) arm
The MRP comprises of 3-4 meals a day (850kcal/day) supplied by Counterweight. Participants will be supported by professional research dieticians, and a study clinician. Participant health and medications will be monitored throughout the study.
Offered to the comparator arm after 12 weeks as a control participant.
干预措施: Transthoracic echocardiography (Diagnostic Test)
Low calorie meal replacement plan (MRP) arm
The MRP comprises of 3-4 meals a day (850kcal/day) supplied by Counterweight. Participants will be supported by professional research dieticians, and a study clinician. Participant health and medications will be monitored throughout the study.
Offered to the comparator arm after 12 weeks as a control participant.
干预措施: Low calorie meal replacement plan (Drug)
Low calorie meal replacement plan (MRP) arm
The MRP comprises of 3-4 meals a day (850kcal/day) supplied by Counterweight. Participants will be supported by professional research dieticians, and a study clinician. Participant health and medications will be monitored throughout the study.
Offered to the comparator arm after 12 weeks as a control participant.
干预措施: Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy (Diagnostic Test)
Low calorie meal replacement plan (MRP) arm
The MRP comprises of 3-4 meals a day (850kcal/day) supplied by Counterweight. Participants will be supported by professional research dieticians, and a study clinician. Participant health and medications will be monitored throughout the study.
Offered to the comparator arm after 12 weeks as a control participant.
干预措施: Blood test (Diagnostic Test)
Low calorie meal replacement plan (MRP) arm
The MRP comprises of 3-4 meals a day (850kcal/day) supplied by Counterweight. Participants will be supported by professional research dieticians, and a study clinician. Participant health and medications will be monitored throughout the study.
Offered to the comparator arm after 12 weeks as a control participant.
干预措施: 6 minute walk test (6MWT) (Diagnostic Test)
Low calorie meal replacement plan (MRP) arm
The MRP comprises of 3-4 meals a day (850kcal/day) supplied by Counterweight. Participants will be supported by professional research dieticians, and a study clinician. Participant health and medications will be monitored throughout the study.
Offered to the comparator arm after 12 weeks as a control participant.
干预措施: Assessment of quality of life and heart failure symptoms (Other)
Low calorie meal replacement plan (MRP) arm
The MRP comprises of 3-4 meals a day (850kcal/day) supplied by Counterweight. Participants will be supported by professional research dieticians, and a study clinician. Participant health and medications will be monitored throughout the study.
Offered to the comparator arm after 12 weeks as a control participant.
干预措施: Assessment of sarcopenia (Other)
Low calorie meal replacement plan (MRP) arm
The MRP comprises of 3-4 meals a day (850kcal/day) supplied by Counterweight. Participants will be supported by professional research dieticians, and a study clinician. Participant health and medications will be monitored throughout the study.
Offered to the comparator arm after 12 weeks as a control participant.
干预措施: Assessment of frailty (Other)
Low calorie meal replacement plan (MRP) arm
The MRP comprises of 3-4 meals a day (850kcal/day) supplied by Counterweight. Participants will be supported by professional research dieticians, and a study clinician. Participant health and medications will be monitored throughout the study.
Offered to the comparator arm after 12 weeks as a control participant.
干预措施: Qualitative interview (Other)
Wait list control arm: Guideline driven care with attention control arm followed by optional MRP
Dietary advice to participants will be given in line with NICE guidelines for cardiovascular risk modification. Heart failure specific advice on exercise will be given in line with guidelines. After 12 weeks as a control participant, these individuals will then have the option to receive the meal replacement plan and repeat assessments after a further 12 weeks.
干预措施: Low calorie meal replacement plan (Drug)
Wait list control arm: Guideline driven care with attention control arm followed by optional MRP
Dietary advice to participants will be given in line with NICE guidelines for cardiovascular risk modification. Heart failure specific advice on exercise will be given in line with guidelines. After 12 weeks as a control participant, these individuals will then have the option to receive the meal replacement plan and repeat assessments after a further 12 weeks.
干预措施: Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy (Diagnostic Test)
Wait list control arm: Guideline driven care with attention control arm followed by optional MRP
Dietary advice to participants will be given in line with NICE guidelines for cardiovascular risk modification. Heart failure specific advice on exercise will be given in line with guidelines. After 12 weeks as a control participant, these individuals will then have the option to receive the meal replacement plan and repeat assessments after a further 12 weeks.
干预措施: Transthoracic echocardiography (Diagnostic Test)
Wait list control arm: Guideline driven care with attention control arm followed by optional MRP
Dietary advice to participants will be given in line with NICE guidelines for cardiovascular risk modification. Heart failure specific advice on exercise will be given in line with guidelines. After 12 weeks as a control participant, these individuals will then have the option to receive the meal replacement plan and repeat assessments after a further 12 weeks.
干预措施: Blood test (Diagnostic Test)
Wait list control arm: Guideline driven care with attention control arm followed by optional MRP
Dietary advice to participants will be given in line with NICE guidelines for cardiovascular risk modification. Heart failure specific advice on exercise will be given in line with guidelines. After 12 weeks as a control participant, these individuals will then have the option to receive the meal replacement plan and repeat assessments after a further 12 weeks.
干预措施: Electrocardiogram (Diagnostic Test)
Wait list control arm: Guideline driven care with attention control arm followed by optional MRP
Dietary advice to participants will be given in line with NICE guidelines for cardiovascular risk modification. Heart failure specific advice on exercise will be given in line with guidelines. After 12 weeks as a control participant, these individuals will then have the option to receive the meal replacement plan and repeat assessments after a further 12 weeks.
干预措施: Accelerometery (Diagnostic Test)
Wait list control arm: Guideline driven care with attention control arm followed by optional MRP
Dietary advice to participants will be given in line with NICE guidelines for cardiovascular risk modification. Heart failure specific advice on exercise will be given in line with guidelines. After 12 weeks as a control participant, these individuals will then have the option to receive the meal replacement plan and repeat assessments after a further 12 weeks.
干预措施: 6 minute walk test (6MWT) (Diagnostic Test)
Wait list control arm: Guideline driven care with attention control arm followed by optional MRP
Dietary advice to participants will be given in line with NICE guidelines for cardiovascular risk modification. Heart failure specific advice on exercise will be given in line with guidelines. After 12 weeks as a control participant, these individuals will then have the option to receive the meal replacement plan and repeat assessments after a further 12 weeks.
干预措施: Assessment of quality of life and heart failure symptoms (Other)
Wait list control arm: Guideline driven care with attention control arm followed by optional MRP
Dietary advice to participants will be given in line with NICE guidelines for cardiovascular risk modification. Heart failure specific advice on exercise will be given in line with guidelines. After 12 weeks as a control participant, these individuals will then have the option to receive the meal replacement plan and repeat assessments after a further 12 weeks.
干预措施: Assessment of sarcopenia (Other)
Wait list control arm: Guideline driven care with attention control arm followed by optional MRP
Dietary advice to participants will be given in line with NICE guidelines for cardiovascular risk modification. Heart failure specific advice on exercise will be given in line with guidelines. After 12 weeks as a control participant, these individuals will then have the option to receive the meal replacement plan and repeat assessments after a further 12 weeks.
干预措施: Qualitative interview (Other)
Low calorie meal replacement plan (MRP) arm
The MRP comprises of 3-4 meals a day (850kcal/day) supplied by Counterweight. Participants will be supported by professional research dieticians, and a study clinician. Participant health and medications will be monitored throughout the study.
Offered to the comparator arm after 12 weeks as a control participant.
干预措施: Skeletal muscle strength using handgrip strength (Diagnostic Test)
Wait list control arm: Guideline driven care with attention control arm followed by optional MRP
Dietary advice to participants will be given in line with NICE guidelines for cardiovascular risk modification. Heart failure specific advice on exercise will be given in line with guidelines. After 12 weeks as a control participant, these individuals will then have the option to receive the meal replacement plan and repeat assessments after a further 12 weeks.
干预措施: Skeletal muscle strength using handgrip strength (Diagnostic Test)
结局指标
主要结局
Change in the distance walked during 6 minute walk test (6MWT)
时间窗: Assessed at baseline and 12 weeks, optional repeat at 24 weeks
The primary outcome measure is a change in the distance walked on 6MWT measured in meters
次要结局
- Beneficial reverse cardiovascular remodelling(Assessed at baseline and 12 weeks, optional repeat at 24 weeks)
- Change in upper limb muscle power(Assessed at baseline and 12 weeks, optional repeat at 24 weeks)
- Improvement in exercise tolerance(Assessed at baseline and 12 weeks, optional repeat at 24 weeks)
- Improvement in symptoms of heart failure(Assessed at baseline and 12 weeks, optional repeat at 24 weeks)
- Change in sarcopenia(Assessed at baseline and 12 weeks, optional repeat at 24 weeks)
- Exploratory outcome: Improving skeletal and cardiac energetics(Baseline and 12 weeks)
- Exploratory outcome: change in fibroinflammatory biomarker panel(This will be evaluated at baseline and at 12 weeks)
- Beneficial reverse cardiovascular remodelling(Assessed at baseline and 12 weeks, optional repeat at 24 weeks)
- Change in physical activity levels(Assessed at baseline and 12 weeks, optional repeat at 24 weeks)
- Change in upper limb muscle power(Assessed at baseline and 12 weeks, optional repeat at 24 weeks)
- Improvement in exercise tolerance(Assessed at baseline and 12 weeks, optional repeat at 24 weeks)
- Improvement in symptoms of heart failure(Assessed at baseline and 12 weeks, optional repeat at 24 weeks)
- Change in frailty(Assessed at baseline and 12 weeks, optional repeat at 24 weeks)
- Change in sarcopenia(Assessed at baseline and 12 weeks, optional repeat at 24 weeks)
- Exploratory outcome: Improving skeletal and cardiac energetics(Baseline and 12 weeks)
- Exploratory outcome: change in fibroinflammatory biomarker panel(This will be evaluated at baseline and at 12 weeks)