NCT05942287 The Effect of Obesity and Weight Loss in Heart Failure With Reduced Ejection Fraction.
| NCT ID | NCT05942287 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oxford |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-05-24 |
| Primary Completion | 2026-12-31 |
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 110 participants in total. It began in 2023-05-24 with a primary completion date of 2026-12-31.
⚠ 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 reduced 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: * The heart's shape and how well it pumps blood * 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 may 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 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 determined by left ventricular ejection fraction 20-45% * Body mass index \> 27.5kg/m\^2 Exclusion Criteria: * Contraindications to magnetic resonance imaging * NYHA class IV * Pregnancy, planned pregnancy or lactating * Significant valvular, ischemic, infiltrative or other potentially confounding cardiac disease * 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 NCT05942287 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05942287 currently recruiting?
Yes, NCT05942287 is actively recruiting participants. Contact the research team at jenny.rayner@cardiov.ox.ac.uk for enrollment information.
Where is the NCT05942287 trial being conducted?
This trial is being conducted at Jersey, Jersey, Oxford, United Kingdom.
Who is sponsoring the NCT05942287 clinical trial?
NCT05942287 is sponsored by University of Oxford. The principal investigator is Oliver J Rider, DPhil at University of Oxford. The trial plans to enroll 110 participants.
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