Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT05878912

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

Led by University of Oxford · Updated on 2024-04-24

120

Participants Needed

1

Research Sites

201 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 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Heart failure with preserved ejection fraction (HFpEF)
  • Left ventricular ejection fraction (LVEF) greater than or equal to 50%
  • Body Mass Index (BMI) approximately greater than or equal to 27.5 kg/m^2
Not Eligible

You will not qualify if you...

  • Contraindications to magnetic resonance imaging
  • New York Heart Association (NYHA) class IV
  • Significant valvular, ischemic, infiltrative, or other potentially confounding cardiac disease
  • Pregnancy, planned pregnancy, or breastfeeding
  • Any other conditions that might affect safety or the scientific validity of the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital

Oxford, United Kingdom, OX3 9DU

Actively Recruiting

Loading map...

Research Team

J

Jiliu Pan, BMBCh

CONTACT

J

Jenny Rayner, DPhil

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here