NCT05942287

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
8mo left

Started May 2023

Typical duration for not_applicable heart-failure

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
May 2023Dec 2026

Study Start

First participant enrolled

May 24, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

3.6 years

First QC Date

July 3, 2023

Last Update Submit

February 21, 2025

Conditions

Heart FailureHeart Failure With Reduced Ejection FractionObesityOverweight

Keywords

heart failureweight losslow energy dietreduced ejection fraction

Outcome Measures

Primary Outcomes (1)

  • Left ventricular ejection fraction

    On cardiac magnetic resonance imaging (CMR)

    Change from baseline at 3-6 months

Secondary Outcomes (4)

  • Body weight

    Change from baseline at 3-6 months

  • Six minute walk distance

    Change from baseline at 3-6 months

  • Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Change from baseline at 3-6 months

  • N-terminal pro brain natriuretic peptide (NTproBNP)

    Change from baseline at 3-6 months

Other Outcomes (2)

  • Left ventricular mass

    Change from baseline at 3-6 months

  • Left atrial volume

    Change from baseline at 3-6 months

Study Arms (2)

Diet intervention

EXPERIMENTAL

Diet intervention (in addition to standard clinical care)

Other: Diet intervention

Standard clinical care

NO INTERVENTION

Standard clinical care only

Interventions

Diet interventionOTHER

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.

Diet intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart failure determined by left ventricular ejection fraction 20-45%
  • Body mass index \> 27.5kg/m\^2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jersey General Hospital

Jersey, Jersey, JE1 3QS, Jersey

RECRUITING

Jenny Rayner

Oxford, OX3 9DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart FailureObesityOverweightWeight Loss

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Oliver J Rider, DPhil

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Rayner, DPhil

CONTACT

+441865221172jenny.rayner@cardiov.ox.ac.uk

Max Fenski, MD

CONTACT

+441865221172max.fenski@cardiov.ox.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 12, 2023

Study Start

May 24, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 25, 2025

Record last verified: 2025-02

Locations

JE(1)GB(1)