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

Last updated: February 21, 2025
Sponsor: University of Oxford
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Obesity

Weight Loss

Treatment

Diet intervention

Clinical Study ID

NCT05942287
161729 (D)
15/SC/0004
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Heart failure determined by left ventricular ejection fraction 20-45%

  • Body mass index > 27.5kg/m^2

Exclusion

Exclusion Criteria:

  • Contraindications to magnetic resonance imaging

  • NYHA class IV

  • Pregnancy, planned pregnancy or lactating

  • Significant valvular, ischemic, infiltrative or other potentially confoundingcardiac disease

  • Any other conditions which may potentially compromise the safety or scientificvalidity of the study

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: Diet intervention
Phase:
Study Start date:
May 24, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Jersey General Hospital

    Jersey, JE1 3QS
    Jersey

    Active - Recruiting

  • Jenny Rayner

    Oxford, OX3 9DU
    United Kingdom

    Active - Recruiting

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