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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05878912
- Acronym / sponsor ID
- OWL-HFPEF / 161729 (C)
- Keywords
- Weight loss, Heart failure, Preserved ejection fraction, Obesity, Overweight, Magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Detailed description
An interim analysis is planned at 60 recruits to review the recruitment target.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet | Experimental | Other: Diet interventionDiet intervention (in addition to standard clinical care) |
| Control | No intervention | –Standard clinical care only |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Heart failure with preserved ejection fraction (HFpEF)
- Left ventricular ejection fraction (LVEF) =/> 50%
- Body Mass Index (BMI) approximately =/> 27.5 kg/m^2
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet interventionThe 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. | Other | Diet |
Primary outcome
Left atrial volume
Time frame: Change from baseline at 3-6 months
measured on cardiac magnetic resonance imaging
4 secondary outcomes
Body weight
Time frame: Change from baseline at 3-6 months
Six minute walk distance
Time frame: Change from baseline at 3-6 months
N-terminal pro brain natriuretic peptide (NT pro BNP)
Time frame: Change from baseline at 3-6 months
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Change from baseline at 3-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oliver J Rider, DPhil principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiliu Pan, BMBCh (+44(0)1865234591, jiliu.pan@cardiov.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left atrial volume (time frame: Change from baseline at 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.