Clinical trial NCT06768437: The Role of Epicardial Adiposity in Heart Failure With Preserved Ejection Fraction
Official title: The Role of Epicardial Adiposity in Heart Failure With Preserved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure With Preserved Ejection Fraction (HFPEF)
Keywords: Heart failure
Heart failure with preserved ejection fraction
Epicardial adipose tissue
Adiposity
Lead sponsor: University of Leicester
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females, aged ≥18 years old, with a diagnosis of HFpEF with and without obesity.

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.

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/1.73m2. Patients with MRI-compatible devices are be excluded.
* Women who are pregnant

Primary outcomes:
measure: Epicardial adipose tissue volume
timeFrame: At baseline
measure: Epicardial Adipose tissue CT attenuation
timeFrame: At baseline
measure: Left ventricular mass:volume ratio
timeFrame: At baseline
Secondary outcomes:
measure: Left ventricular global longitudinal strain
timeFrame: At baseline
measure: Left ventricular circumferential peak early diastolic strain rate
timeFrame: At baseline
measure: Myocardial blood flow
timeFrame: At baseline
measure: left ventricular filling pressure
timeFrame: At baseline
measure: Six minute walk test
timeFrame: At baseline
measure: Coronary artery plaque volume
timeFrame: At baseline
measure: Left ventricular mass
timeFrame: At baseline
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Glenfield Hospital, University Hospitals of Leicester
state: Leicestershire
Study officials:
References: