Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
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
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