The Role of Epicardial Adiposity in Heart Failure With Preserved Ejection Fraction (EAT HFpEF)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Preserved Ejection Fraction (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 Type: Observational
• Enrollment (Estimated): 130

Contacts and Locations

• Study Contact: Name: Gaurav S Gulsin, MBChB(Hons); Phone Number: +44 (0)116 258 3038; Email: gg149@le.ac.uk
• Study Contact Backup: Name: Sarah L Ayton, MBBS; Email: sa768@le.ac.uk

Study Locations

• United Kingdom
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE3 9QP
      • Recruiting
      • Glenfield Hospital, University Hospitals of Leicester
      • Contact: Sarah L Ayton, MBBS; Phone Number: +44 (0)116 258 3038; Email: sa768@leicester.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Males and females, aged ≥18 years old, with a diagnosis of HFpEF with and without obesity.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants with HFpEF; Obese and non-obese participants with heart failure with preserved ejection fraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epicardial adipose tissue volume	Cardiac CT	At baseline
Epicardial Adipose tissue CT attenuation	Cardiac CT	At baseline
Left ventricular mass:volume ratio	Cardiac MRI	At baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Leicester

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2037

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Heart failure; Epicardial adipose tissue; Heart failure with preserved ejection fraction; Adiposity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Nutrition Disorders; Heart Diseases; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Heart Failure; Obesity
• Other Study ID Numbers: 1003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No