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

Primary Purpose

Heart Failure, Heart Failure With Reduced Ejection Fraction, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Diet intervention
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, weight loss, low energy diet, reduced ejection fraction

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Jenny RaynerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diet intervention

Standard clinical care

Arm Description

Diet intervention (in addition to standard clinical care)

Standard clinical care only

Outcomes

Primary Outcome Measures

Left ventricular ejection fraction
On cardiac magnetic resonance imaging (CMR)

Secondary Outcome Measures

Body weight
Six minute walk distance
Kansas City Cardiomyopathy Questionnaire (KCCQ)
A scale of 0 - 100, where higher scores indicate better outcomes.
N-terminal pro brain natriuretic peptide (NTproBNP)

Full Information

First Posted
July 3, 2023
Last Updated
July 3, 2023
Sponsor
University of Oxford
Collaborators
British Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05942287
Brief Title
The Effect of Obesity and Weight Loss in Heart Failure With Reduced Ejection Fraction.
Acronym
SLEnDR
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
British Heart Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Heart Failure With Reduced Ejection Fraction, Obesity, Overweight
Keywords
heart failure, weight loss, low energy diet, reduced ejection fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diet intervention
Arm Type
Experimental
Arm Description
Diet intervention (in addition to standard clinical care)
Arm Title
Standard clinical care
Arm Type
No Intervention
Arm Description
Standard clinical care only
Intervention Type
Other
Intervention Name(s)
Diet intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction
Description
On cardiac magnetic resonance imaging (CMR)
Time Frame
Change from baseline at 3-6 months
Secondary Outcome Measure Information:
Title
Body weight
Time Frame
Change from baseline at 3-6 months
Title
Six minute walk distance
Time Frame
Change from baseline at 3-6 months
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
A scale of 0 - 100, where higher scores indicate better outcomes.
Time Frame
Change from baseline at 3-6 months
Title
N-terminal pro brain natriuretic peptide (NTproBNP)
Time Frame
Change from baseline at 3-6 months
Other Pre-specified Outcome Measures:
Title
Left ventricular mass
Description
on CMR
Time Frame
Change from baseline at 3-6 months
Title
Left atrial volume
Description
on CMR
Time Frame
Change from baseline at 3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenny Rayner, DPhil
Phone
+441865221172
Email
jenny.rayner@cardiov.ox.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Ines Abdessalam, PhD
Phone
+441865221172
Email
ines.abdesselam@cardiov.ox.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver J Rider, DPhil
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jenny Rayner
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny Rayner, DPhil
Phone
+441865221172
Email
jenny.rayner@cardiov.ox.ac.uk
First Name & Middle Initial & Last Name & Degree
Oliver Rider, DPhil
First Name & Middle Initial & Last Name & Degree
Jenny Rayner, DPhil
First Name & Middle Initial & Last Name & Degree
Ines Abdessalam, PhD
First Name & Middle Initial & Last Name & Degree
Jiliu Pan, BMBCh

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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