The Role of Epicardial Adiposity in Heart Failure With Preserved Ejection Fraction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure With Preserved Ejection Fraction (HFPEF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Epicardial adipose tissue volume [Time frame: At baseline]
- Epicardial Adipose tissue CT attenuation [Time frame: At baseline]
- Left ventricular mass:volume ratio [Time frame: At baseline]
Secondary outcome measures (7)
- Left ventricular global longitudinal strain [Time frame: At baseline]
- Left ventricular circumferential peak early diastolic strain rate [Time frame: At baseline]
- Myocardial blood flow [Time frame: At baseline]
- left ventricular filling pressure [Time frame: At baseline]
- Six minute walk test [Time frame: At baseline]
- Coronary artery plaque volume [Time frame: At baseline]
- Left ventricular mass [Time frame: At baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United Kingdom · 1 center
- Glenfield Hospital, University Hospitals of Leicester — Leicester
Identifiers
NCT: NCT06768437 · 1003