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

Recruiting now · Not applicable

Conditions studied: Heart Failure, Heart Failure With Reduced Ejection Fraction, Obesity, Overweight

In brief

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.

Key facts

Study ID

NCT05942287

Run by

University of Oxford

People needed

110

Starts

2023-05-24

Expected to finish

2026-12-31

Last updated by the study team

2025-02-25

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Heart failure determined by left ventricular ejection fraction 20-45%
• Body mass index > 27.5kg/m\^2

You may not qualify if…

• 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

Where it is running

• Jersey General Hospital — Jersey, Jersey, Jersey (enrolling)
• Jenny Rayner — Oxford, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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