Tests weight loss through meal replacements in people with heart failure and obesity
Tests a low-calorie meal replacement diet in overweight or obese adults with heart failure.
Plain-language title generated from the registry record
Registry title: The Effect of Obesity and Weight Loss in Heart Failure With Reduced Ejection Fraction.
Key facts
- Where
- Oxford, United KingdomSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT05942287, who can take part
Where in United Kingdom
- Jenny RaynerOxford, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Oxford
- Trial code
- NCT05942287
- Record updated
- 25 February 2025
- Original description
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.Read full original descriptionShow less
The Effects of Obesity and Weight Loss in Heart Failure: Imaging the Obesity Paradox Using Magnetic Resonance Imaging and Spectroscopy - Heart Failure With Reduced Ejection Fraction Substudy
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.
Inclusion: Heart failure determined by left ventricular ejection fraction 20-45%; Body mass index > 27.5kg/m\^2.
Exclusion: 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; Contraindications to magnetic resonance imaging; NYHA class IV; Pregnancy, planned pregnancy or lactating.