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

February 21, 2025 updated by: University of Oxford

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Jersey
      • Jersey, Jersey, JE1 3QS
  • United Kingdom
      • Oxford, United Kingdom, OX3 9DU
        • Recruiting
        • Jenny Rayner
        • Principal Investigator:
          • Oliver Rider, DPhil
        • Sub-Investigator:
          • Jenny Rayner, DPhil
        • Sub-Investigator:
          • Jiliu Pan, BMBCh
        • Contact:
        • Sub-Investigator:
          • Ines Abdessalam, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction
Time Frame: Change from baseline at 3-6 months
On cardiac magnetic resonance imaging (CMR)
Change from baseline at 3-6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular mass
Time Frame: Change from baseline at 3-6 months
on CMR
Change from baseline at 3-6 months
Left atrial volume
Time Frame: Change from baseline at 3-6 months
on CMR
Change from baseline at 3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

British Heart Foundation

Investigators

  • Principal Investigator: Oliver J Rider, DPhil, University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 161729 (D)
  • 15/SC/0004 (Other Identifier: Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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