The Protocol for the 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)
Introduction 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 rando...
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2025-01-01
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| author | Noelle Robertson Melanie J Davies Thomas Yates Gerry P McCann Gaurav Singh Gulsin Emer M Brady Joanne V Wormleighton Eylem Levelt Oliver Rider Jiliu Pan Christopher Miller Iain Squire Mehak Asad Fardad Soltani Michelle Hadjiconstantinou Rachel L Brown Joanna M Bilak |
| author_facet | Noelle Robertson Melanie J Davies Thomas Yates Gerry P McCann Gaurav Singh Gulsin Emer M Brady Joanne V Wormleighton Eylem Levelt Oliver Rider Jiliu Pan Christopher Miller Iain Squire Mehak Asad Fardad Soltani Michelle Hadjiconstantinou Rachel L Brown Joanna M Bilak |
| author_sort | Noelle Robertson |
| collection | DOAJ |
| description | Introduction 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.Methods and analysis 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.Statistical analysis 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.Ethics and dissemination 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.Trial registration number NCT05887271. |
| format | Article |
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| institution | Kabale University |
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| publishDate | 2025-01-01 |
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| spelling | doaj-art-aba59450e4334a32a1f626241c2105e22025-01-30T11:30:13ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-094722The Protocol for the 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)Noelle Robertson0Melanie J Davies1Thomas Yates2Gerry P McCann3Gaurav Singh Gulsin4Emer M Brady5Joanne V Wormleighton6Eylem Levelt7Oliver Rider8Jiliu Pan9Christopher Miller10Iain Squire11Mehak Asad12Fardad Soltani13Michelle Hadjiconstantinou14Rachel L Brown15Joanna M Bilak162 Department of Neuroscience, Psychology and Behaviour, University of Leicester, University Road, Leicester LE1 7RH, UK3 Leicester Diabetes Research Centre, Leicester General Hospital, Gwendolen Road, Leicester LE5 4PW, UK3 Leicester Diabetes Research Centre, Leicester General Hospital, Gwendolen Road, Leicester LE5 4PW, UK1 Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester LE3 9QP, UK1 Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester LE3 9QP, UK1 Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester LE3 9QP, UK1 Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester LE3 9QP, UK4 Multidisciplinary Cardiovascular Research Centre and Biomedical Imaging Science Department, Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds LS2 9JT, UK5 Oxford Centre for Clinical Magnetic Resonance Research, University of Oxford, John Radcliffe Hospital, Headley Way, Oxford OX3 9DU, UK5 Oxford Centre for Clinical Magnetic Resonance Research, University of Oxford, John Radcliffe Hospital, Headley Way, Oxford OX3 9DU, UK6 Division of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Oxford Road, Manchester M13 9PL, UK1 Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester LE3 9QP, UK4 Multidisciplinary Cardiovascular Research Centre and Biomedical Imaging Science Department, Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds LS2 9JT, UK6 Division of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Oxford Road, Manchester M13 9PL, UK1 Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester LE3 9QP, UK1 Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester LE3 9QP, UK1 Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester LE3 9QP, UKIntroduction 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.Methods and analysis 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.Statistical analysis 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.Ethics and dissemination 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.Trial registration number NCT05887271.https://bmjopen.bmj.com/content/15/1/e094722.full |
| spellingShingle | Noelle Robertson Melanie J Davies Thomas Yates Gerry P McCann Gaurav Singh Gulsin Emer M Brady Joanne V Wormleighton Eylem Levelt Oliver Rider Jiliu Pan Christopher Miller Iain Squire Mehak Asad Fardad Soltani Michelle Hadjiconstantinou Rachel L Brown Joanna M Bilak The Protocol for the 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) BMJ Open |
| title | The Protocol for the 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) |
| title_full | The Protocol for the 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) |
| title_fullStr | The Protocol for the 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) |
| title_full_unstemmed | The Protocol for the 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) |
| title_short | The Protocol for the 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) |
| title_sort | protocol for the 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 |
| url | https://bmjopen.bmj.com/content/15/1/e094722.full |
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