AMEND Preserved
Research type
Research Study
Full title
A Multi-Ethnic, multi-centre raNdomised, controlled trial of a low-energy Diet for improving functional status in Heart failure with PRESERVED ejection fraction (AME
IRAS ID
317281
Contact name
Gerry P McCann
Contact email
Sponsor organisation
Dr
Duration of Study in the UK
2 years, 0 months, 2 days
Research 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 is unable to relax sufficiently 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 using low energy diets 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. In this study, we will assess if this is achievable in a multi-ethnic cohort of patients with established HFpEF. We will invite 102 adults and allocate them by chance (much like tossing a coin) into two groups: either a 12-week diet or health advice on how to lose weight. We will see if weight loss over 12 weeks can improve heart function, symptoms and ability to exercise. We will get participants’ views on changing their diet and how this has impacted on their symptoms. This will help us plan treatments in the future to get maximum benefits, and individualize support to patients from different cultural backgrounds.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
22/EM/0215
Date of REC Opinion
10 Nov 2022
REC opinion
Further Information Favourable Opinion