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NCT Number: NCT05942287

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jersey General Hospital, Jersey

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet intervention

Other

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 outcomes

  1. Left ventricular ejection fraction

    Time frame: Change from baseline at 3-6 months

    On cardiac magnetic resonance imaging (CMR)

Secondary outcomes

  1. Body weight

    Time frame: Change from baseline at 3-6 months

  2. Six minute walk distance

    Time frame: Change from baseline at 3-6 months

  3. 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.

  4. N-terminal pro brain natriuretic peptide (NTproBNP)

    Time frame: Change from baseline at 3-6 months

Other outcomes

  1. Left ventricular mass

    Time frame: Change from baseline at 3-6 months

    on CMR

  2. Left atrial volume

    Time frame: Change from baseline at 3-6 months

    on CMR

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny Rayner, DPhil

CONTACT

[email protected]

+441865221172

Max Fenski, MD

CONTACT

[email protected]

+441865221172

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • British Heart Foundation

Registry information

Official study 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

Acronym: SLEnDR

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 12, 2023
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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