RecruitingRecruiting
The Role of Epicardial Adiposity in Heart Failure With Preserved Ejection Fraction
NCT06768437 · University of Leicester
In plain English
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About this study
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.
Eligibility 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
Study design
Enrollment target: 130 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-02-12
Estimated completion: 2037-08
Last updated: 2026-04-30
Primary outcomes
- • Epicardial adipose tissue volume (At baseline)
- • Epicardial Adipose tissue CT attenuation (At baseline)
- • Left ventricular mass:volume ratio (At baseline)
Sponsor
University of Leicester · other
Contacts & investigators
ContactGaurav S Gulsin, MBChB(Hons) · contact · gg149@le.ac.uk · +44 (0)116 258 3038
ContactSarah L Ayton, MBBS · contact · sa768@le.ac.uk
All locations (1)
Glenfield Hospital, University Hospitals of LeicesterRecruiting
Leicester, Leicestershire, United Kingdom