Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT05942287

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

Led by University of Oxford · Updated on 2025-02-25

110

Participants Needed

2

Research Sites

188 weeks

Total Duration

On this page

Sponsors

U

University of Oxford

Lead Sponsor

B

British Heart Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Heart failure with left ventricular ejection fraction between 20% and 45%
  • Body mass index greater than 27.5 kg/m²
  • Age between 18 and 85 years
Not Eligible

You will not qualify if you...

  • Contraindications to magnetic resonance imaging
  • New York Heart Association (NYHA) class IV heart failure
  • Pregnancy, planned pregnancy, or lactating
  • Significant valvular, ischemic, infiltrative, or other confounding cardiac diseases
  • Any other conditions that may compromise safety or study validity

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Jersey General Hospital

Jersey, Jersey, Jersey, JE1 3QS

Actively Recruiting

2

Jenny Rayner

Oxford, United Kingdom, OX3 9DU

Actively Recruiting

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Research Team

J

Jenny Rayner, DPhil

CONTACT

M

Max Fenski, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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