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Clinical Trials/NCT06768437
NCT06768437
Recruiting
Not Applicable

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

University of Leicester1 site in 1 country130 target enrollmentFebruary 12, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure With Preserved Ejection Fraction (HFPEF)
Sponsor
University of Leicester
Enrollment
130
Locations
1
Primary Endpoint
Epicardial adipose tissue volume
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 12, 2025
End Date
August 2037
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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 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/1.73m
  • Patients with MRI-compatible devices are be excluded.
  • Women who are pregnant

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Left ventricular global longitudinal strain(At baseline)
  • Left ventricular circumferential peak early diastolic strain rate(At baseline)
  • Myocardial blood flow(At baseline)
  • left ventricular filling pressure(At baseline)
  • Six minute walk test(At baseline)
  • Coronary artery plaque volume(At baseline)
  • Left ventricular mass(At baseline)

Study Sites (1)

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