Clinical trial

The Effect of Obesity and Weight Loss in Heart Failure With Preserved Ejection Fraction

Recruiting now · Not applicable · 1 countries · Registry ID NCT05878912

Recruiting nowNot applicableInterventional

What this study is about

This study looks at the effects of weight loss in people who have heart failure with preserved ejection fraction (HFpEF) and are overweight or obese. The main questions it aims to answer are whether weight loss in this group of people improves: 1. The heart's shape, how well it pumps blood and how well it uses fuels 2. The person's quality of life and how much they can exercise Participants will attend 2 study visits, separated by 3-6 months. The intervention period takes place in between the 2 study visits. Each study visit will involve measurements including: * Symptom and quality of life questionnaires * Body measurements such as height and weight * Blood tests * Ultrasound scans of the heart (echocardiogram) * Magnetic Resonance Imaging (MRI) scans of the heart * Exercise components during the scans * 6 minute walk test Participants are randomly allocated (in other words, by lottery) to either 'diet' or 'control' groups. The control group will continue standard care. The diet group will be enrolled in a weight loss program supervised by the study team. Participants in the diet group will replace their usual meals with meal replacement products specifically designed to deliver a low calorie diet for weight loss. The products will consist of formula soups, shakes and porridges. This diet would last 8 weeks, followed by a guided period of food reintroduction and maintenance.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 85 Years

SexAll

Healthy volunteersNot accepted

ConditionHeart Failure With Preserved Ejection Fraction, Obesity

Full registry criteria

Inclusion Criteria: * Heart failure with preserved ejection fraction (HFpEF) * Left ventricular ejection fraction (LVEF) =/\> 50% * Body Mass Index (BMI) approximately =/\> 27.5 kg/m\^2 Exclusion Criteria: * Contraindications to magnetic resonance imaging * NYHA class IV * Significant valvular, ischemic, infiltrative or other potentially confounding cardiac disease * Pregnancy, planned pregnancy or lactating * Any other conditions which may potentially compromise the safety or scientific validity of the study

Treatments and study arms

Diet intervention

Other

The diet intervention delivers a weight loss program. The main component is a total diet replacement low energy diet. The intervention includes a gradual food reintroduction phase and maintenance strategies.

Primary outcomes

Left atrial volumeChange from baseline at 3-6 months

measured on cardiac magnetic resonance imaging

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital🇬🇧 Oxford, United Kingdom

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Jiliu Pan, BMBChContact

Email · Call +44 (0)1865 234591

Oliver Rider, DPhilPrincipal Investigator

Jenny Rayner, DPhilSub Investigator