Heart Failure With Preserved Ejection FractionOWL-HFPEFNCT05878912
The Effect of Obesity and Weight Loss in Heart Failure With Preserved Ejection Fraction
A study testing Diet intervention in people with Heart Failure With Preserved Ejection Fraction and Obesity, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Obesity
- What is being tested?
- Diet intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jan 2023to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure with preserved ejection fraction (HFpEF)
- Left ventricular ejection fraction (LVEF) =/> 50%
- Body Mass Index (BMI) approximately =/> 27.5 kg/m^2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital
Oxford, OX3 9DU
Jiliu Pan, BMBCh, +44 (0)1865 234591, jiliu.pan@cardiov.ox.ac.uk
Oliver Rider, DPhil
About this study
Official title: The Effects of Obesity and Weight Loss in Heart Failure: Imaging the Obesity Paradox Using Magnetic Resonance Imaging and Spectroscopy - Heart Failure With Preserved Ejection Fraction Substudy
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:
Read more
- The heart's shape, how well it pumps blood and how well it uses fuels
- 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.
Read the detailed description
An interim analysis is planned at 60 recruits to review the recruitment target.
- Being tested
- Diet intervention
- Keywords
- Weight loss, Heart failure, Preserved ejection fraction, Obesity, Overweight, Magnetic resonance imaging
- Medical subject headings
- Obesity, Weight Loss, Heart Failure, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Diet | Experimental | Diet intervention (in addition to standard clinical care) Receives: Other: Diet intervention |
| Control | No intervention | Standard clinical care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left atrial volume
measured on cardiac magnetic resonance imaging
Measured: Change from baseline at 3-6 months
Secondary outcomes (4)
Body weight
Measured: Change from baseline at 3-6 months
Six minute walk distance
Measured: Change from baseline at 3-6 months
N-terminal pro brain natriuretic peptide (NT pro BNP)
Measured: Change from baseline at 3-6 months
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Score of 0 to 100, High scores indicate better outcome
Measured: Change from baseline at 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start20 Jan 2023
- Primary completionOct 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Oliver J Rider, DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878912
- Sponsor's protocol ID
- 161729 (C)
- Other IDs
- 15/SC/0004, FS/CRTF/22/24293
- Acronym
- OWL-HFPEF
- Status last verified
- Apr 2024
- First submitted
- 15 Mar 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No