The Role of Epicardial Adiposity in Heart Failure With Preserved Ejection Fraction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Leicester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Males and females, aged ≥18 years old, with a diagnosis of HFpEF with and without obesity.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
130 Participants
are grouped into 1 trial groupGroup A: Participants with HFpEF
Trial outcomes
Primary outcomes
1
Epicardial adipose tissue volume
Cardiac CT
Time frame
At baseline2
Epicardial Adipose tissue CT attenuation
Cardiac CT
Time frame
At baseline3
Left ventricular mass:volume ratio
Cardiac MRI
Time frame
At baselineSecondary outcomes
1
Left ventricular global longitudinal strain
Cardiac MRI
Time frame
At baseline2
Left ventricular circumferential peak early diastolic strain rate
Cardiac MRI
Time frame
At baseline3
Myocardial blood flow
Cardiac MRI
Time frame
At baseline4
left ventricular filling pressure
Echocardiography (Tissue Doppler)
Time frame
At baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov