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

NCT05878912 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-04-24

No results posted yet for this study

Summary

This study looks at the effects of weight loss in people who have heart failure with preserved 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:

1. The heart's shape, how well it pumps blood and how well it uses fuels
2. 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 will 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
* Exercise components during the scans
* 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • British Heart Foundation

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Oliver J Rider, DPhil · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-20
Primary Completion
2025-10-31
Completion
2026-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05878912 on ClinicalTrials.gov