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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Other: Diet intervention

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiliu Pan, BMBCh; Phone Number: +44(0)1865234591; Email: jiliu.pan@cardiov.ox.ac.uk
• Study Contact Backup: Name: Jenny Rayner, DPhil; Phone Number: +44(0)1865221172; Email: jenny.rayner@cardiov.ox.ac.uk

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 9DU
    • Recruiting
    • Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital
    • Contact: Jiliu Pan, BMBCh; Phone Number: +44 (0)1865 234591; Email: jiliu.pan@cardiov.ox.ac.uk
    • Principal Investigator: Oliver Rider, DPhil
    • Sub-Investigator: Jenny Rayner, DPhil
    • Sub-Investigator: Jiliu Pan, BMBCh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard clinical care only
Experimental: Diet; Diet intervention (in addition to standard clinical care)	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kansas City Cardiomyopathy Questionnaire (KCCQ)	Score of 0 to 100, High scores indicate better outcome	Change from baseline at 3-6 months
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
New York Heart Association (NYHA) class	Scale from 1 to 4, Higher score indicates worse outcome	Change from baseline at 3-6 months
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
Left ventricular mass	calculated from volumetric analysis using cardiac magnetic resonance imaging	Change from baseline at 3-6 months
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
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
Left atrial volume	On echocardiography	Change from baseline at 3-6 months

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: British Heart Foundation
• Investigators: Principal Investigator: Oliver J Rider, DPhil, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Estimated): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Heart failure; Overweight; Magnetic resonance imaging; Weight loss; Preserved ejection fraction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Heart Failure; Obesity; Weight Loss
• Other Study ID Numbers: 161729 (C); 15/SC/0004 (Other Identifier: Rsearch Ethics Committee); FS/CRTF/22/24293 (Other Grant/Funding Number: British Heart Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No