The Effect of Obesity and Weight Loss in Heart Failure With Reduced Ejection Fraction.
NCT ID: NCT05942287
Last Updated: 2025-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2023-05-24
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Diet intervention
Diet intervention (in addition to standard clinical care)
Diet intervention
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.
Standard clinical care
Standard clinical care only
No interventions assigned to this group
Interventions
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Diet intervention
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.
Eligibility Criteria
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Inclusion Criteria
* Body mass index \> 27.5kg/m\^2
Exclusion Criteria
* NYHA class IV
* Pregnancy, planned pregnancy or lactating
* 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
18 Years
85 Years
ALL
No
Sponsors
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British Heart Foundation
OTHER
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Oliver J Rider, DPhil
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Jersey General Hospital
Jersey, Jersey, Jersey
Jenny Rayner
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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15/SC/0004
Identifier Type: OTHER
Identifier Source: secondary_id
161729 (D)
Identifier Type: -
Identifier Source: org_study_id
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