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

Recruiting

• Conditions: Heart Failure With Preserved Ejection Fraction (HFPEF)

• Registration Number: NCT06768437
• Lead Sponsor: University of Leicester

Brief 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 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 Timeline

• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2025-01-06
• Study Start: 2025-02-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-27
• Primary Completion: 2027-08
• Study Completion: 2037-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Participant is willing and able to give informed consent for participation in the study.
• Aged ≥18 years old
• Diagnosed with HFpEF and diagnosis confirmed by an experienced cardiologist using the HFA-PEFF diagnostic algorithm
• Echocardiogram performed within 12 months
• Able to understand written English

Exclusion Criteria

• LV ejection fraction <45%
• 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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epicardial Adipose tissue CT attenuation	At baseline	Cardiac CT
Left ventricular mass:volume ratio	At baseline	Cardiac MRI
Epicardial adipose tissue volume	At baseline	Cardiac CT

Secondary Outcome Measures

Name	Time	Method
Left ventricular global longitudinal strain	At baseline	Cardiac MRI
Left ventricular circumferential peak early diastolic strain rate	At baseline	Cardiac MRI
Myocardial blood flow	At baseline	Cardiac MRI
left ventricular filling pressure	At baseline	Echocardiography (Tissue Doppler)
Six minute walk test	At baseline
Coronary artery plaque volume	At baseline	Cardiac CT angiography
Left ventricular mass	At baseline	Cardiac MRI

Trial Locations

Locations (1)

Glenfield Hospital, University Hospitals of Leicester; 🇬🇧 Leicester, Leicestershire, United Kingdom