The Effect of Obesity and Weight Loss in Heart Failure With Preserved Ejection Fraction (OWL-HFPEF)

University of Oxford

Status: Enrolling

Conditions: Heart Failure With Preserved Ejection Fraction; Obesity

Treatments: Other: Diet intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05878912

161729 (C)

15/SC/0004 (Other Identifier)

FS/CRTF/22/24293 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

An interim analysis is planned at 60 recruits to review the recruitment target.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Diet

Experimental group

Description:

Diet intervention (in addition to standard clinical care)

Treatment:

Other: Diet intervention

Control

No Intervention group

Description:

Standard clinical care only