NCT05878912Recruiting
The Effect of Obesity and Weight Loss in Heart Failure With Preserved Ejection Fraction
The Effects of Obesity and Weight Loss in Heart Failure: Imaging the Obesity Paradox Using Magnetic Resonance Imaging and Spectroscopy - Heart Failure With Preserved Ejection Fraction Substudy
Source: ClinicalTrials.gov · Last updated 24 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 15 Mar 2023
- Start date
- 20 Jan 2023
- Primary completion date
- Oct 2025
- Lead sponsor
- University of Oxford
- Diseases
- Heart failure, Obesity
- NCT number
- NCT05878912
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 20 Jan 2023 to the primary completion date, Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Contraindications to magnetic resonance imaging
- NYHA class IV
- Pregnancy, planned pregnancy or lactating
Who the study is looking for
- Heart failure with preserved ejection fraction (HFpEF)
- Left ventricular ejection fraction (LVEF) =/\> 50%
- Body Mass Index (BMI) approximately =/\> 27.5 kg/m\^2
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.