Clinical trial NCT05878912: The Effect of Obesity and Weight Loss in Heart Failure With Preserved Ejection Fraction
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Obesity
Keywords: Weight loss
Heart failure
Preserved ejection fraction
Obesity
Overweight
Magnetic resonance imaging
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2023-05-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Left atrial volume
timeFrame: Change from baseline at 3-6 months
Secondary outcomes:
measure: Body weight
timeFrame: Change from baseline at 3-6 months
measure: Six minute walk distance
timeFrame: Change from baseline at 3-6 months
measure: N-terminal pro brain natriuretic peptide (NT pro BNP)
timeFrame: Change from baseline at 3-6 months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Change from baseline at 3-6 months
Other outcomes:
measure: New York Heart Association (NYHA) class
timeFrame: Change from baseline at 3-6 months
measure: Insulin resistance
timeFrame: Change from baseline at 3-6 months
measure: Left ventricular mass
timeFrame: Change from baseline at 3-6 months
measure: E/E'
timeFrame: Change from baseline at 3-6 months
measure: Pulmonary artery systolic pressure
timeFrame: Change from baseline at 3-6 months
measure: Left atrial volume
timeFrame: Change from baseline at 3-6 months
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital
Study officials:
affiliation: University of Oxford
name: Oliver J Rider, DPhil
role: PRINCIPAL_INVESTIGATOR
References: