RecruitingNot ApplicableNCT05878912

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

The Effects of Obesity and Weight Loss in Heart Failure: Imaging the Obesity Paradox Using Magnetic Resonance Imaging and Spectroscopy - Heart Failure With Preserved Ejection Fraction Substudy


Sponsor

University of Oxford

Enrollment

120 participants

Start Date

Jan 20, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how obesity and weight loss affect the heart in people with a type of heart failure called HFpEF — heart failure with preserved ejection fraction. This condition means the heart still pumps with normal strength, but the muscle has become stiff. The study uses heart imaging (MRI) to measure the effects. **You may be eligible if...** - You have been diagnosed with heart failure with preserved ejection fraction (HFpEF) - Your heart's pumping function (ejection fraction) is 50% or greater - Your body mass index (BMI) is approximately 27.5 or higher **You may NOT be eligible if...** - You cannot have an MRI (e.g., due to a pacemaker or metal implants) - You are in the most severe class of heart failure (NYHA Class IV) - You have significant valve disease, coronary artery disease, or other major heart conditions - You are pregnant or planning a pregnancy - You have other conditions that could compromise safety or the accuracy of the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDiet intervention

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.


Locations(1)

Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital

Oxford, United Kingdom

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NCT05878912


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