SLEnDR: The Effect of Obesity and Weight Loss in Heart Failure With Reduced Ejection Fraction.

Sponsor

University of Oxford (Other)

Overall Status

Recruiting

CT.gov ID

NCT05942287

Collaborator

British Heart Foundation (Other)

110

Enrollment

Location

Arms

43.3

Anticipated Duration (Months)

2.5

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 reduced 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 and how well it pumps blood
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 may 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 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 Heart Failure With Reduced Ejection Fraction Obesity Overweight	Other: Diet intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 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 Reduced Ejection Fraction Substudy

Actual Study Start Date :

May 24, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diet intervention 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: Standard clinical care Standard clinical care only

Arm

Intervention/Treatment

Experimental: Diet intervention

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: Standard clinical care

Standard clinical care only

Outcome Measures

Primary Outcome Measures

Left ventricular ejection fraction [Change from baseline at 3-6 months]
On cardiac magnetic resonance imaging (CMR)

Secondary Outcome Measures

Body weight [Change from baseline at 3-6 months]
Six minute walk distance [Change from baseline at 3-6 months]
Kansas City Cardiomyopathy Questionnaire (KCCQ) [Change from baseline at 3-6 months]
A scale of 0 - 100, where higher scores indicate better outcomes.
N-terminal pro brain natriuretic peptide (NTproBNP) [Change from baseline at 3-6 months]

Other Outcome Measures

Left ventricular mass [Change from baseline at 3-6 months]
on CMR
Left atrial volume [Change from baseline at 3-6 months]
on CMR

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Heart failure determined by left ventricular ejection fraction 20-45%
Body mass index > 27.5kg/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
Any other conditions which may potentially compromise the safety or scientific validity of the study