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The Role of Epicardial Adiposity in Heart Failure With Preserved Ejection Fraction

Sponsor: University of Leicester

NCT ID: NCT06768437

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 150 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
130
Started
2025-02-12
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure with preserved ejection fraction (hfpef)
  • • Clinical study - 130 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with heart failure with preserved ejection fraction (hfpef)

Where?

  • • Leicester - Glenfield Hospital, University Hospitals of Leicester

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Heart Failure With Preserved Ejection Fraction (HFPEF)

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Participant is willing and able to give agreement to take part 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 take part

  • ✗LV ejection fraction \<45%
  • ✗Recovered ejection fraction (previous ejection fraction \<40%) unless reduced ejection fraction was in context of...
  • ✗Severe primary valvular heart disease
  • ✗HFpEF due to infiltrative cardiomyopathy (heart amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy,...
  • ✗Known heritable, idiopathic or drug-induced lung arterial hypertension
See the full criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Where Is This Study? (1 UK site)

Glenfield Hospital, University Hospitals of Leicester

Leicester LE3 9QP, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Gaurav S Gulsin, MBChB(Hons)

Sponsor contact

CONTACT

+44 (0)116 258 3038 gg149@le.ac.uk

Sarah L Ayton, MBBS

Sponsor contact

CONTACT

sa768@le.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-04