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| ID | Type | Description | Link |
|---|---|---|---|
| 15/SC/0004 | Other Identifier | Rsearch Ethics Committee | |
| FS/CRTF/22/24293 | Other Grant/Funding Number | British Heart Foundation |
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| Name | Class |
|---|---|
| British Heart Foundation | OTHER |
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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:
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:
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.
An interim analysis is planned at 60 recruits to review the recruitment target.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet | Experimental | Diet intervention (in addition to standard clinical care) |
|
| Control | No Intervention | Standard clinical care only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Left atrial volume | measured on cardiac magnetic resonance imaging | Change from baseline at 3-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| New York Heart Association (NYHA) class | Scale from 1 to 4, Higher score indicates worse outcome | Change from baseline at 3-6 months |
| Insulin resistance | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR); calculated from measurements of blood glucose (millimoles per litre) and blood insulin (picomoles per litre) concentrations |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiliu Pan, BMBCh | Contact | +44(0)1865234591 | jiliu.pan@cardiov.ox.ac.uk | |
| Jenny Rayner, DPhil | Contact | +44(0)1865221172 | jenny.rayner@cardiov.ox.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Oliver J Rider, DPhil | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital | Recruiting | Oxford | OX3 9DU | United Kingdom |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D006333 | Heart Failure |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Change from baseline at 3-6 months |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | Score of 0 to 100, High scores indicate better outcome | Change from baseline at 3-6 months |
| Change from baseline at 3-6 months |
| Left ventricular mass | calculated from volumetric analysis using cardiac magnetic resonance imaging | Change from baseline at 3-6 months |
| E/E' | A measure of diastolic function on echocardiography, based on E (mitral inflow velocity) and E' (tissue doppler E' velocity) | Change from baseline at 3-6 months |
| Pulmonary artery systolic pressure | On echocardiography, calculated based on tricuspid valve regurgitant velocity and estimated right atrial pressure using inferior vena cava measurement | Change from baseline at 3-6 months |
| Left atrial volume | On echocardiography | Change from baseline at 3-6 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |