The Effect of Obesity and Weight Loss in Heart Failure With Preserved Ejection Fraction

Study Overview
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Brief Summary
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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: The heart's shape, how well it pumps blood and how well it uses fuels 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.

Official Title
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The Effects of Obesity and Weight Loss in Heart Failure: Imaging the Obesity Paradox Using Magnetic Resonance Imaging and Spectroscopy - Heart Failure With Preserved Ejection Fraction Substudy

Conditions
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Heart Failure With Preserved Ejection Fraction, Obesity

Intervention / Treatment
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* Other: Diet intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet<br>Diet intervention (in addition to standard clinical care) | Other: Diet intervention<br>* 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.<br>|
| No Intervention: Control<br>Standard clinical care only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left atrial volume index | measured on cardiac magnetic resonance imaging | Change from baseline at 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight loss, Heart failure, Preserved ejection fraction, Obesity, Overweight, Magnetic resonance imaging