Heart Failure With Preserved Ejection Fraction, Obesity
Conditions
Keywords
Weight loss, Heart failure, Preserved ejection fraction, Obesity, Overweight, Magnetic resonance imaging
Brief summary
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.
Detailed description
An interim analysis is planned at 60 recruits to review the recruitment target.
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 with preserved ejection fraction (HFpEF) * Left ventricular ejection fraction (LVEF) =/\> 50% * Body Mass Index (BMI) approximately =/\> 27.5 kg/m\^2
Exclusion criteria
* Contraindications to magnetic resonance imaging * NYHA class IV * Significant valvular, ischemic, infiltrative or other potentially confounding cardiac disease * Pregnancy, planned pregnancy or lactating * Any other conditions which may potentially compromise the safety or scientific validity of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left atrial volume | Change from baseline at 3-6 months | measured on cardiac magnetic resonance imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | Change from baseline at 3-6 months | Score of 0 to 100, High scores indicate better outcome |
| Body weight | Change from baseline at 3-6 months | — |
| Six minute walk distance | Change from baseline at 3-6 months | — |
| N-terminal pro brain natriuretic peptide (NT pro BNP) | Change from baseline at 3-6 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary artery systolic pressure | 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 |
| Left atrial volume | Change from baseline at 3-6 months | On echocardiography |
| New York Heart Association (NYHA) class | Change from baseline at 3-6 months | Scale from 1 to 4, Higher score indicates worse outcome |
| Insulin resistance | 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 |
| Left ventricular mass | Change from baseline at 3-6 months | calculated from volumetric analysis using cardiac magnetic resonance imaging |
| E/E' | 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) |
Countries
United Kingdom
Contacts
Primary ContactJiliu Pan, BMBCh
Backup ContactJenny Rayner, DPhil
Outcome results
None listed