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| ID | Type | Description | Link |
|---|---|---|---|
| 15/SC/0004 | Other Identifier | Research Ethics Committee |
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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 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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet intervention | Experimental | Diet intervention (in addition to standard clinical care) |
|
| Standard clinical care | 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 ventricular ejection fraction | On cardiac magnetic resonance imaging (CMR) | 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 | |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular mass | on CMR | Change from baseline at 3-6 months |
| Left atrial volume | on CMR | Change from baseline at 3-6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenny Rayner, DPhil | Contact | +441865221172 | jenny.rayner@cardiov.ox.ac.uk | |
| Max Fenski, MD | Contact | +441865221172 | max.fenski@cardiov.ox.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Oliver J Rider, DPhil | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jersey General Hospital | Recruiting | Jersey | Jersey | JE1 3QS | Jersey |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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A scale of 0 - 100, where higher scores indicate better outcomes. |
| Change from baseline at 3-6 months |
| N-terminal pro brain natriuretic peptide (NTproBNP) | Change from baseline at 3-6 months |
| Jenny Rayner | Recruiting | Oxford | OX3 9DU | United Kingdom |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |