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

Sponsor

University of Oxford (Other)

Overall Status

Recruiting

CT.gov ID

NCT05878912

Collaborator

British Heart Foundation (Other)

120

Enrollment

Location

Arms

46.4

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure With Preserved Ejection Fraction Obesity	Other: Diet intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 20, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: Control Standard clinical care only

Arm

Intervention/Treatment

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.

No Intervention: Control

Standard clinical care only

Outcome Measures

Primary Outcome Measures

Left atrial volume [Change from baseline at 3-6 months]
millilitres, measured on cardiac magnetic resonance imaging
Left atrial volume [Change from baseline at 3-6 months]
millilitres, measured on echocardiography

Secondary Outcome Measures

Body weight [Change from baseline at 3-6 months]
kilograms
Exercise capacity [Change from baseline at 3-6 months]
metres of distance walked on 6 minute walk test
Left ventricular mass [Change from baseline at 3-6 months]
grams, calculated from volumetric analysis using cardiac magnetic resonance imaging
N-terminal pro brain natriuretic peptide (NTproBNP) [Change from baseline at 3-6 months]
nanograms per litre

Other Outcome Measures

Exercise lung water density [Change from baseline at 3-6 months]
cardiac magnetic resonance imaging
Body fat fraction [Change from baseline at 3-6 months]
percent (%), Bioelectrical Impedance Analysis
Waist to hip circumference ratio [Change from baseline at 3-6 months]
calculated from waist circumference and hip circumference measured in centimetres
New York Heart Association (NYHA) class [Change from baseline at 3-6 months]
Scale from 1 to 4, Higher score indicates worse outcome
Tricuspid valve regurgitation peak velocity [Change from baseline at 3-6 months]
metres per second, echocardiography (rest and 35 Watts exercise)
Mitral inflow velocity (E) [Change from baseline at 3-6 months]
metres per second, measured on echocardiography (at rest and on 35 Watts exercise)
Tissue doppler velocity (E') [Change from baseline at 3-6 months]
metres per second, measured on echocardiography (at rest and on 35 Watts exercise)
E / E' [Change from baseline at 3-6 months]
ratio calculated from mitral inflow velocity and tissue doppler velocity
Kansas City Cardiomyopathy Questionnaire (KCCQ) [Change from baseline at 3-6 months]
Score of 0 to 100, High scores indicate better outcome
Insulin resistance [Change from baseline at 3-6 months]
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR); calculated from measurements of blood glucose (millimoles per litre) and blood insulin (picomoles per litre) concentrations

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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
Pregnancy, planned pregnancy or lactating
Significant valvular, ischemic, infiltrative or other potentially confounding cardiac disease
Significant immobility
Any other conditions which may potentially compromise the safety or scientific validity of the study