Actively Recruiting
Led by University of Leicester · Updated on 2025-10-07
63
Participants Needed
3
Research Sites
N/A
Total Duration
U
University of Leicester
Lead Sponsor
U
University of Oxford
Collaborating Sponsor
Heart failure with preserved ejection fraction (HFpEF) is a common and serious condition linked to obesity and type 2 diabetes. It occurs when the heart muscle cannot relax properly to pump blood, causing fluid build-up, breathlessness, and difficulty with physical activity. Treatments are limited, so this study is evaluating whether a low calorie diet can improve heart function, symptoms, and exercise ability in a diverse group of adults with established HFpEF. The study is sponsored by the University of Leicester and involves 63 adult participants. Participants will be randomly assigned to one of two groups: one group will follow a low calorie meal replacement plan (MRP) consisting of 3-4 meals per day totaling about 850 kcal, supported by dietitians and clinicians for 12 weeks. The other group will receive standard care with health advice on weight loss and heart failure exercise guidelines, then after 12 weeks will have the option to try the meal replacement plan. The study will take place across multiple sites and includes a possible extension to repeat the diet after 12 weeks for the control group. During the study, participants will undergo various assessments including a 6-minute walk test to measure exercise capacity, cardiovascular imaging, blood tests, muscle strength evaluations, and questionnaires on heart failure symptoms and quality of life. Activity levels will be tracked using an accelerometer worn for 7 days. Optional interviews will explore participants' experiences with dietary changes. The main outcome is the change in distance walked in 6 minutes after 12 weeks, with other measures including heart function, symptoms, physical activity, and muscle health. Safety and health will be closely monitored throughout the trial.
CONDITIONS
A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants follow a low calorie meal replacement plan with support from dieticians and clinicians. Health and medications are monitored throughout the study.
Visits including assessments at baseline and 12 weeks
Duration - Up to 12 additional weeks
Optional repeat assessments for participants who continue after 12 weeks to monitor changes in physical activity, muscle power, heart failure symptoms, and cardiovascular remodeling.
Optional visit at 24 weeks
Total: 3 locations
1
University of Leicester, Glenfield Hospital, Groby Road
Leicester, Leicestershire, United Kingdom, LE3 9QP
Actively Recruiting
2
University of Manchester, Wythenshawe Hospital, Southmoor Road
Manchester, United Kingdom, M23 9LT
Actively Recruiting
3
University of Oxford, John Radcliffe Hospital, Headley Way
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
S
Sarah L Ayton, MBBS
E
Emer M Brady, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Joanna M Bilak, Iain Squire, Joanne V Wormleighton...
https://pubmed.ncbi.nlm.nih.gov/39880434