Bilak Joanna M, Squire Iain, Wormleighton Joanne V, Brown Rachel L, Hadjiconstantinou Michelle, Robertson Noelle, Davies Melanie J, Yates Thomas, Asad Mehak, Levelt Eylem, Pan Jiliu, Rider Oliver, Soltani Fardad, Miller Christopher, Gulsin Gaurav Singh, Brady Emer M, McCann Gerry P
Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester LE3 9QP, UK.
Department of Neuroscience, Psychology and Behaviour, University of Leicester, University Road, Leicester LE1 7RH, UK.
BMJ Open. 2025 Jan 28;15(1):e094722. doi: 10.1136/bmjopen-2024-094722.
Heart failure with preserved ejection fraction (HFpEF) is characterised by severe exercise intolerance, particularly in those living with obesity. Low-energy meal-replacement plans (MRPs) have shown significant weight loss and potential cardiac remodelling benefits. This pragmatic randomised trial aims to evaluate the efficacy of MRP-directed weight loss on exercise intolerance, symptoms, quality of life and cardiovascular remodelling in a multiethnic cohort with obesity and HFpEF.
Prospective multicentre, open-label, blinded endpoint randomised controlled trial comparing low-energy MRP with guideline-driven care plus health coaching. Participants (n=110, age ≥18 years) with HFpEF and clinical stability for at least 3 months will be randomised to receive either MRP (810 kcal/day) or guideline-driven care for 12 weeks. Randomisation is stratified by sex, ethnicity, and baseline Sodium Glucose Cotransporter-2 inhibitor (SGLT2-i) use, using the electronic database RedCap with allocation concealment. Key exclusion criteria include severe valvular, lung or renal disease, infiltrative cardiomyopathies, symptomatic biliary disease or history of an eating disorder. Participants will undergo glycometabolic profiling, echocardiography, MRI for cardiovascular structure and function, body composition analysis (including visceral and subcutaneous adiposity quantification), Kansas City Cardiomyopathy Questionnaire (KCCQ) and Six-Minute Walk Test (6MWT), at baseline and 12 weeks. An optional 24-week assessment will include non-contrast CMR, 6MWT, KCCQ score. Optional substudies include a qualitative study assessing participants' experiences and barriers to adopting MRP, and skeletal muscle imaging and cardiac energetics using 31Phosphorus MR spectroscopy.
Complete case analysis will be conducted with adjustment for baseline randomisation factors including sex, ethnicity and baseline SGLT2-i use. The primary outcome is the change in distance walked during the 6MWT. The primary imaging endpoint is the change in left atrial volume indexed to height on cardiac MRI. Key secondary endpoints include symptoms and quality of life measured by the KCCQ score.
The Health Research Authority Ethics Committee (REC reference 22/EM/0215) has approved the study. The findings of this study will be published in peer-reviewed journals.
NCT05887271.
射血分数保留的心力衰竭（HFpEF）的特征是严重的运动不耐受，尤其是在肥胖患者中。低能量代餐计划（MRP）已显示出显著的体重减轻以及潜在的心脏重塑益处。这项实用性随机试验旨在评估在一个多民族肥胖和HFpEF队列中，MRP指导的体重减轻对运动不耐受、症状、生活质量和心血管重塑的疗效。
一项前瞻性多中心、开放标签、终点设盲的随机对照试验，比较低能量MRP与指南指导的护理加健康指导。患有HFpEF且临床稳定至少3个月的参与者（n = 110，年龄≥18岁）将被随机分配接受MRP（810千卡/天）或指南指导的护理，为期12周。使用带有分配隐藏功能的电子数据库RedCap，按性别、种族和基线钠-葡萄糖协同转运蛋白2抑制剂（SGLT2-i）使用情况进行分层随机化。主要排除标准包括严重的瓣膜、肺部或肾脏疾病、浸润性心肌病、有症状的胆道疾病或饮食失调史。参与者将在基线和12周时接受糖代谢分析、超声心动图、用于心血管结构和功能的MRI、身体成分分析（包括内脏和皮下脂肪定量）、堪萨斯城心肌病问卷（KCCQ）和六分钟步行试验（6MWT）。一项可选的24周评估将包括非对比CMR、6MWT、KCCQ评分。可选的子研究包括一项定性研究，评估参与者采用MRP的经历和障碍，以及使用31磷磁共振波谱进行骨骼肌成像和心脏能量学研究。
将进行完全病例分析，并对包括性别、种族和基线SGLT2-i使用情况在内的基线随机化因素进行调整。主要结局是6MWT期间行走距离的变化。主要影像学终点是心脏MRI上左心房容积指数相对于身高的变化。关键次要终点包括通过KCCQ评分测量的症状和生活质量。
健康研究管理局伦理委员会（REC编号22/EM/0215）已批准该研究。本研究的结果将发表在同行评审期刊上。
NCT05887271。
