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

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942287
• Other study ID #: 161729 (D)
• Secondary ID: 15/SC/0004
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2023
• Source: University of Oxford
• Contact: Jenny Rayner, DPhil
• Phone: +441865221172
• Email: jenny.rayner[@]cardiov.ox.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction
• Obesity
• Overweight
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Jenny Rayner	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Left ventricular mass	on CMR	Change from baseline at 3-6 months
Other	Left atrial volume	on CMR	Change from baseline at 3-6 months
Primary	Left ventricular ejection fraction	On cardiac magnetic resonance imaging (CMR)	Change from baseline at 3-6 months
Secondary	Body weight		Change from baseline at 3-6 months
Secondary	Six minute walk distance		Change from baseline at 3-6 months
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ)	A scale of 0 - 100, where higher scores indicate better outcomes.	Change from baseline at 3-6 months
Secondary	N-terminal pro brain natriuretic peptide (NTproBNP)		Change from baseline at 3-6 months