NCT05878912 The Effect of Obesity and Weight Loss in Heart Failure With Preserved Ejection Fraction
| NCT ID | NCT05878912 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oxford |
| Condition | Heart Failure With Preserved Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-01-20 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-01-20 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Oliver J Rider, DPhil
PRINCIPAL INVESTIGATOR
University of Oxford
Frequently Asked Questions
Who can join the NCT05878912 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Heart Failure With Preserved Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05878912 currently recruiting?
Yes, NCT05878912 is actively recruiting participants. Contact the research team at jiliu.pan@cardiov.ox.ac.uk for enrollment information.
Where is the NCT05878912 trial being conducted?
This trial is being conducted at Oxford, United Kingdom.
Who is sponsoring the NCT05878912 clinical trial?
NCT05878912 is sponsored by University of Oxford. The principal investigator is Oliver J Rider, DPhil at University of Oxford. The trial plans to enroll 120 participants.
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