The Effect of Obesity and Weight Loss in Heart Failure With Reduced Ejection Fraction.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diet intervention.
- Who it may be relevant to
- Registry conditions: Heart Failure, Heart Failure With Reduced Ejection Fraction, Obesity, Overweight. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Jersey, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Left ventricular ejection fraction [Time frame: Change from baseline at 3-6 months]
Secondary outcome measures (4)
- Body weight [Time frame: Change from baseline at 3-6 months]
- Six minute walk distance [Time frame: Change from baseline at 3-6 months]
- Kansas City Cardiomyopathy Questionnaire (KCCQ) [Time frame: Change from baseline at 3-6 months]
- N-terminal pro brain natriuretic peptide (NTproBNP) [Time frame: Change from baseline at 3-6 months]
Eligibility criteria
Inclusion criteria
- Heart failure determined by left ventricular ejection fraction 20-45%
- Body mass index > 27.5kg/m\^2
Exclusion criteria
- Contraindications to magnetic resonance imaging
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Jersey · 1 center
- Jersey General Hospital — Jersey
United Kingdom · 1 center
- Jenny Rayner — Oxford
Identifiers
NCT: NCT05942287 · 161729 (D) · 15/SC/0004