NCT Number: NCT05878912
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Oxford, OX3 9DU, United Kingdom
Location status: Recruiting
Jenny Rayner, DPhil
SUB_INVESTIGATOR
Jiliu Pan, BMBCh
CONTACT
Jiliu Pan, BMBCh
SUB_INVESTIGATOR
Oliver Rider, DPhil
PRINCIPAL_INVESTIGATOR
An interim analysis is planned at 60 recruits to review the recruitment target.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The diet intervention delivers a weight loss program. The main component is a total diet replacement low energy diet. The intervention includes a gradual food reintroduction phase and maintenance strategies.
Time frame: Change from baseline at 3-6 months
measured on cardiac magnetic resonance imaging
Time frame: Change from baseline at 3-6 months
Time frame: Change from baseline at 3-6 months
Time frame: Change from baseline at 3-6 months
Time frame: Change from baseline at 3-6 months
Score of 0 to 100, High scores indicate better outcome
Time frame: Change from baseline at 3-6 months
Scale from 1 to 4, Higher score indicates worse outcome
Time frame: Change from baseline at 3-6 months
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR); calculated from measurements of blood glucose (millimoles per litre) and blood insulin (picomoles per litre) concentrations
Time frame: Change from baseline at 3-6 months
calculated from volumetric analysis using cardiac magnetic resonance imaging
Time frame: Change from baseline at 3-6 months
A measure of diastolic function on echocardiography, based on E (mitral inflow velocity) and E' (tissue doppler E' velocity)
Time frame: Change from baseline at 3-6 months
On echocardiography, calculated based on tricuspid valve regurgitant velocity and estimated right atrial pressure using inferior vena cava measurement
Time frame: Change from baseline at 3-6 months
On echocardiography
Contact information is provided by the study sponsor or research team.
Jenny Rayner, DPhil
CONTACT
Jiliu Pan, BMBCh
CONTACT
University of Oxford
Other
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
Acronym: OWL-HFPEF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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