Diet intervention
OtherThe 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.
NCT Number: NCT05942287
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Jersey General Hospital, Jersey
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
On cardiac magnetic resonance imaging (CMR)
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
A scale of 0 - 100, where higher scores indicate better outcomes.
Time frame: Change from baseline at 3-6 months
Time frame: Change from baseline at 3-6 months
on CMR
Time frame: Change from baseline at 3-6 months
on CMR
Contact information is provided by the study sponsor or research team.
Jenny Rayner, DPhil
CONTACT
Max Fenski, MD
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 Reduced Ejection Fraction Substudy
Acronym: SLEnDR
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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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