Actively Recruiting
A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction
Led by University of Leicester · Updated on 2025-10-07
63
Participants Needed
3
Research Sites
129 weeks
Total Duration
On this page
Sponsors
U
University of Leicester
Lead Sponsor
U
University of Oxford
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 63 adults will be invited and allocate by chance into two groups: 1) 12-weeks of a low calorie diet or 2) Standard care and health advice on how to lose weight followed by the option to have the low calorie diet after 12-weeks. 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.
CONDITIONS
Official Title
A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established diagnosis of heart failure with preserved ejection fraction (EF > 45%) by a heart specialist or nurse
- Clinically stable for at least 3 months with no hospital admissions
- Obesity defined as BMI ≥30 kg/m2 for white Europeans or ≥27 kg/m2 for Asian, Middle Eastern, or Black ethnicities
- Age 18 years or older
You will not qualify if you...
- Unable to walk or perform a 6-minute walk test
- Unable to follow a low-energy meal replacement plan
- HFpEF caused by infiltrative cardiomyopathy, genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy, pericardial disease, or congenital heart disease
- Previously reduced ejection fraction below 40% unless due to tachycardia-induced cardiomyopathy
- Known heritable, idiopathic, or drug-induced pulmonary arterial hypertension
- Severe chronic obstructive pulmonary disease (FEV1 < 1.0L)
- Severe primary valvular heart disease
- Anemia with hemoglobin less than 100 g/L
- Severe kidney disease with eGFR less than 30 ml/min/1.73 m2
- Weight loss greater than 5 kg in the last 3 months
- Symptomatic gallstones or cholecystitis within the last 3 months
- Active substance abuse of drugs or alcohol
- History of bariatric surgery in the last 3 years
- Active illness likely to cause weight changes
- Pregnant women or those considering pregnancy
- Participation in another clinical trial affecting diet or weight
- History of severe mental illness including eating disorders
- Diagnosis of Type 1 diabetes mellitus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
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
Research Team
S
Sarah L Ayton, MBBS
CONTACT
E
Emer M Brady, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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