Heart Failure, Heart Failure With Reduced Ejection Fraction, Obesity, Overweight
Conditions
Keywords
heart failure, weight loss, low energy diet, reduced ejection fraction
Brief summary
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
OTHERDiet 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.
Sponsors
British Heart Foundation
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular ejection fraction | Change from baseline at 3-6 months | On cardiac magnetic resonance imaging (CMR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| N-terminal pro brain natriuretic peptide (NTproBNP) | Change from baseline at 3-6 months | — |
| Body weight | Change from baseline at 3-6 months | — |
| Six minute walk distance | Change from baseline at 3-6 months | — |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | Change from baseline at 3-6 months | A scale of 0 - 100, where higher scores indicate better outcomes. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular mass | Change from baseline at 3-6 months | on CMR |
| Left atrial volume | Change from baseline at 3-6 months | on CMR |
Countries
Jersey, United Kingdom
Contacts
Primary ContactJenny Rayner, DPhil
Backup ContactMax Fenski, MD
Outcome results
None listed