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

Obesity Clinical Trial

— OWL-HFPEF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05878912
• Other study ID #: 161729 (C)
• Secondary ID: 15/SC/0004FS/CRT
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: University of Oxford
• Contact: Jiliu Pan, BMBCh
• Phone: +44(0)1865234591
• Email: jiliu.pan[@]cardiov.ox.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Obesity
• Weight Loss

Intervention

Other:
• Diet intervention
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.

Locations

Country	Name	City	State
United Kingdom	Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	New York Heart Association (NYHA) class	Scale from 1 to 4, Higher score indicates worse outcome	Change from baseline at 3-6 months
Other	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	Change from baseline at 3-6 months
Other	Left ventricular mass	calculated from volumetric analysis using cardiac magnetic resonance imaging	Change from baseline at 3-6 months
Other	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
Other	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
Other	Left atrial volume	On echocardiography	Change from baseline at 3-6 months
Primary	Left atrial volume	measured on cardiac magnetic resonance imaging	Change from baseline at 3-6 months
Secondary	Body weight		Change from baseline at 3-6 months
Secondary	Six minute walk distance		Change from baseline at 3-6 months
Secondary	N-terminal pro brain natriuretic peptide (NT pro BNP)		Change from baseline at 3-6 months
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ)	Score of 0 to 100, High scores indicate better outcome	Change from baseline at 3-6 months