a randomised, controlled trial of a low-energy diet for improving functional status in heart failure with preserved ejection fraction preserved ejection fraction

Conditions: Heart Failure With Preserved Ejection Fraction; Heart Failure, Diastolic; Diabetes Mellitus, Type 2; Diabetes Mellitus Type 2 in Obese; Obesity Adult Onset

Summary: 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 102 adults will be invited and allocate by chance into two groups: either a 12-week diet or health advice on how to lose weight. 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.

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 three sites (leicester, manchester and oxford) to assess its efficacy in improving exercise intolerance, symptoms, quality of life, cardiovascular remodelling, and skeletal myopathy.

Eligibility criteria:
inclusion criteria: 1. 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 2. clinically stable for ≥ 3 months (no admissions to hospital) 3. obesity (bmi ≥30kg/m2 if white european or ≥27kg/m2 if asian, middle eastern or black ethnicity) 4. age ≥18 exclusion criteria: 1. inability to walk/undertake 6-minute walk test 2. inability to follow a low-energy mrp 3. hfpef due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy/pericardial disease or congenital heart disease95 4. known heritable, idiopathic or drug-induced pulmonary arterial hypertension 5. severe chronic obstructive pulmonary disease (fev1\< 1.0l) 6. severe primary valvular heart disease 7. anaemia (hb\<100g/l) 8. severe renal disease (egfr \< 30 ml/min/1.73 m2) 9. weight loss \> 5kg in preceding 3 months. 10. known gallstones/previous biliary colic

Keywords: heart failure with preserved ejection fraction diastolic heart failure type 2 diabetes mellitus obesity meal replacement plan cardiac magnetic resonance imaging exercise intolerance diabetes remission