NCT05878912

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

An interim analysis is planned at 60 recruits to review the recruitment target.

Conditions

• Heart Failure With Preserved Ejection Fraction
• Obesity

Interventions

Type	Name	Description
OTHER	Diet 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.

Timeline

• Start date: 2023-01-20
• Primary completion: 2025-10-01
• Completion: 2026-12-01
• First posted: 2023-05-30
• Last updated: 2024-04-24

Locations

1 site across 1 country: United Kingdom