NCT05878912

Brief 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:

  • 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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 Progress86%
Jan 2023Dec 2026

Study Start

First participant enrolled

January 20, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

2.7 years

First QC Date

March 15, 2023

Last Update Submit

April 23, 2024

Conditions

Heart Failure With Preserved Ejection FractionObesity

Keywords

Weight lossHeart failurePreserved ejection fractionObesityOverweightMagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Left atrial volume

    measured on cardiac magnetic resonance imaging

    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

  • N-terminal pro brain natriuretic peptide (NT pro BNP)

    Change from baseline at 3-6 months

  • Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Change from baseline at 3-6 months

Other Outcomes (6)

  • New York Heart Association (NYHA) class

    Change from baseline at 3-6 months

  • Insulin resistance

    Change from baseline at 3-6 months

  • Left ventricular mass

    Change from baseline at 3-6 months

  • +3 more other outcomes

Study Arms (2)

Diet

EXPERIMENTAL

Diet intervention (in addition to standard clinical care)

Other: Diet intervention

Control

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

Eligibility Criteria

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

You may qualify if:

  • Heart failure with preserved ejection fraction (HFpEF)
  • Left ventricular ejection fraction (LVEF) =/\> 50%
  • Body Mass Index (BMI) approximately =/\> 27.5 kg/m\^2

You may not qualify if:

  • Contraindications to magnetic resonance imaging
  • NYHA class IV
  • Significant valvular, ischemic, infiltrative or other potentially confounding cardiac disease
  • Pregnancy, planned pregnancy or lactating
  • 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 (1)

Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

ObesityWeight LossHeart FailureOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesHeart DiseasesCardiovascular Diseases

Study Officials

  • Oliver J Rider, DPhil

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiliu Pan, BMBCh

CONTACT

+44(0)1865234591jiliu.pan@cardiov.ox.ac.uk

Jenny Rayner, DPhil

CONTACT

+44(0)1865221172jenny.rayner@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

March 15, 2023

First Posted

May 30, 2023

Study Start

January 20, 2023

Primary Completion

October 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)