Heart Failure With Preserved Ejection Fraction (HFPEF)EAT HFpEFNCT06768437
The Role of Epicardial Adiposity in Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure With Preserved Ejection Fraction (HFPEF), run by University of Leicester at 1 site in United Kingdom.
Trial summary
In this study the investigators are aiming to recruit 130 patients with heart failure with preserved ejection fraction who are obese and non-obese to undergo CT and MRI scans, as well as some other investigations including blood tests, to help investigate if having more fat around the heart leads to worse heart… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction (HFPEF)
- How many people
- 130 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Feb 2025to Aug 2037
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males and females, aged ≥18 years old, with a diagnosis of HFpEF with and without obesity.
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Aged ≥18 years old
- Diagnosed with HFpEF by an experienced cardiologist or signs and symptoms of heart failure with a HFA-PEFF score ≥5
- Able to understand written English
Who cannot join
- LV ejection fraction <45%
- Recovered ejection fraction (previous ejection fraction <40%) unless reduced ejection fraction was in context of tachycardia induced cardiomyopathy (eg atrial fibrillation/atrial flutter)
- Severe primary valvular heart disease
- HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy/pericardial disease or congenital heart disease
- Known heritable, idiopathic or drug-induced pulmonary arterial hypertension
- Absolute contraindications to cardiac CT or MRI including estimated glomerular filtration rate (eGFR) ≤30ml/min/1.73m2. Patients with MRI-compatible devices are be excluded.
- Women who are pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah L Ayton, MBBS contact
United Kingdom1 site, 1 recruiting
- Recruiting
Glenfield Hospital, University Hospitals of Leicester
Leicester, Leicestershire, LE3 9QP
Sarah L Ayton, MBBS, +44 (0)116 258 3038, sa768@leicester.ac.uk
About this study
In this study the investigators are aiming to recruit 130 patients with heart failure with preserved ejection fraction who are obese and non-obese to undergo CT and MRI scans, as well as some other investigations including blood tests, to help investigate if having more fat around the heart leads to worse heart function in this condition. This may lead to the development of new treatments aimed at lowering fat levels around the heart and in the rest of the body, specifically to treat HFpEF.
Read the detailed description
Dysregulated adipose tissue, in particular epicardial adipose tissue (EAT; fat around the heart) may be central to the pathogenesis of obesity related HFpEF. Existing studies have been limited by selection bias (only including obese cohorts), limited cardiac structural and functional assessment (primarily using echocardiography) and lack of corroborating biological data to imply causality. Pilot data demonstrate important associations between EAT with concentric LV remodelling in cohorts at high risk of HFpEF.
Further exploration of the role of EAT and other ectopic fat depots in patients with HFpEF with and without obesity, will provide novel insights into mechanisms by which adiposity drives development of HFpEF.
In this single centre, prospective, case-control study the investigators will recruit participants with HFpEF with and without obesity (total N=130) and utilise multimodality imaging to comprehensively characterise the role of excess adiposity and ectopic fat, specifically EAT, to cardiac dysfunction in HFpEF.
- Keywords
- Heart failure, Heart failure with preserved ejection fraction, Epicardial adipose tissue, Adiposity
- Medical subject headings
- Heart Failure, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with HFpEF | Obese and non-obese participants with heart failure with preserved ejection fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epicardial adipose tissue volume
Cardiac CT
Measured: At baseline
Epicardial Adipose tissue CT attenuation
Cardiac CT
Measured: At baseline
Left ventricular mass:volume ratio
Cardiac MRI
Measured: At baseline
Secondary outcomes (7)
Left ventricular global longitudinal strain
Cardiac MRI
Measured: At baseline
Left ventricular circumferential peak early diastolic strain rate
Cardiac MRI
Measured: At baseline
Myocardial blood flow
Cardiac MRI
Measured: At baseline
left ventricular filling pressure
Echocardiography (Tissue Doppler)
Measured: At baseline
Six minute walk test
Measured: At baseline
Coronary artery plaque volume
Cardiac CT angiography
Measured: At baseline
Left ventricular mass
Cardiac MRI
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start12 Feb 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2037 (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 Fraction (HFPEF)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768437
- Sponsor's protocol ID
- 1003
- Acronym
- EAT HFpEF
- Status last verified
- Apr 2026
- First submitted
- 28 Nov 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Epicardial Adiposity in Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT06768437
- Acronym / sponsor ID
- EAT HFpEF / 1003
- Keywords
- Heart failure, Heart failure with preserved ejection fraction, Epicardial adipose tissue, Adiposity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2037 (estimated)
- First posted
- 10 Jan 2025 (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.
In this study the investigators are aiming to recruit 130 patients with heart failure with preserved ejection fraction who are obese and non-obese to undergo CT and MRI scans, as well as some other investigations including blood tests, to help investigate if having more fat around the heart leads to worse heart function in this condition. This may lead to the development of new treatments aimed at lowering fat levels around the heart and in the rest of the body, specifically to treat HFpEF.
Detailed description
Dysregulated adipose tissue, in particular epicardial adipose tissue (EAT; fat around the heart) may be central to the pathogenesis of obesity related HFpEF. Existing studies have been limited by selection bias (only including obese cohorts), limited cardiac structural and functional assessment (primarily using echocardiography) and lack of corroborating biological data to imply causality. Pilot data demonstrate important associations between EAT with concentric LV remodelling in cohorts at high risk of HFpEF.
Further exploration of the role of EAT and other ectopic fat depots in patients with HFpEF with and without obesity, will provide novel insights into mechanisms by which adiposity drives development of HFpEF.
In this single centre, prospective, case-control study the investigators will recruit participants with HFpEF with and without obesity (total N=130) and utilise multimodality imaging to comprehensively characterise the role of excess adiposity and ectopic fat, specifically EAT, to cardiac dysfunction in HFpEF.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with HFpEF | – | –Obese and non-obese participants with heart failure with preserved ejection fraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females, aged ≥18 years old, with a diagnosis of HFpEF with and without obesity.
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Aged ≥18 years old
- Diagnosed with HFpEF by an experienced cardiologist or signs and symptoms of heart failure with a HFA-PEFF score ≥5
- Able to understand written English
Key exclusion criteria (7 listed)
- LV ejection fraction <45%
- Recovered ejection fraction (previous ejection fraction <40%) unless reduced ejection fraction was in context of tachycardia induced cardiomyopathy (eg atrial fibrillation/atrial flutter)
- Severe primary valvular heart disease
- HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy/pericardial disease or congenital heart disease
- Known heritable, idiopathic or drug-induced pulmonary arterial hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epicardial adipose tissue volume
Time frame: At baseline
Cardiac CT
Epicardial Adipose tissue CT attenuation
Time frame: At baseline
Cardiac CT
Left ventricular mass:volume ratio
Time frame: At baseline
Cardiac MRI
7 secondary outcomes
Left ventricular global longitudinal strain
Time frame: At baseline
Left ventricular circumferential peak early diastolic strain rate
Time frame: At baseline
Myocardial blood flow
Time frame: At baseline
left ventricular filling pressure
Time frame: At baseline
Six minute walk test
Time frame: At baseline
Coronary artery plaque volume
Time frame: At baseline
Left ventricular mass
Time frame: At baseline
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 30 Apr 2026.
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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.
Sarah L Ayton, MBBS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction (HFPEF), run by University of Leicester 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 4 inclusion and 7 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 30 Apr 2026. 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 Gaurav S Gulsin, MBChB(Hons) (+44 (0)116 258 3038, gg149@le.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epicardial adipose tissue volume (time frame: At baseline). The study lists 3 primary outcomes in all. 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 30 Apr 2026.