The Role of Ectopic Fat and Heart Attack Risk in HIV
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorUniversity of Liverpool
About this trial
This study is designed to investigate differences between people living with HIV (PLWHIV) and general populations on how the body utilises and stores energy. This study uses magnetic resonance imaging (MRI) to measure fat around the body organs including the heart and liver. The fat around body organs, also known as visceral fat, is known to be associated with metabolic syndrome and a risk factor for developing heart attacks and strokes.
MRI scans are used frequently in hospitals to diagnose a range of conditions. These scans use radio waves to measure protons in body tissues. The machines can reconstruct tissues using complex algorithms to form composite images of body structures. MRI scans do not use ionising radiation and there is no risk to undertaking an MRI in terms of radiation.
We often use MRI scans to assess the hearts' structure and function. In addition, we can use specific MRI sequences to assess the integrity of heart muscle. Heart MRI is often considered the gold standard imaging technique to assess the heart and heart muscle disease. This sub-study will use multiple MRI sequences to assess the heart and the liver. We are aiming to investigate any changes in heart and liver fat. In addition, we will assess any changes in fat levels within the heart muscle cells whilst also assessing for any change in the way the heart is functioning.
PLWHIV have roughly double the risk of heart attacks compared to general populations. Previous studies have demonstrated that this increased risk may arise from the way in which fat is stored and metabolised in the body. We hope this study will give insight into why HIV-positive individuals have increased risks of heart attacks and how reducing visceral fat may reduce risk. It may lead to further medicines or treatment strategies to reduce the risk of heart attacks in HIV-positive individuals.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• >40 years
HIV-positive
Stable ART for >6 months with two VL <40 copies/ml based on local testing protocols
CD4 count >200cells/mm3 for >2 years from recruitment Inclusion Criteria (all)
Disqualifiers
Subjects unable to comply with the study protocol
History of severe renal impairment (eGFR <30ml/min)
History of severe hepatic impairment (Child Pugh Score >9)
Active hepatitis B or hepatitis C
Trial population
50 participants from HIV clinic 50 participants from general population (patients undergoing CT Coronary Angiography for investigation of chest pain)
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Non-interventional
Other interventionNon-interventional
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: People living with HIV1 intervention
Group B: General population0 interventions
Trial outcomes
Primary outcomes
1
Epicardial adipose tissue volume
Epicardial adipose tissue volume measured by cardiac MRI (mm3). Measurment of fat around the heart
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Intramyocardial triglyceride
MR spectroscopy. MEasurement of concentration of intramyocardial lipid content
Time frame
through study completion, an average of 1 year2
Liver fat percentage
As described my MRI spectroscopy protocol. Measurement of fat content of liver cells
Time frame
through study completion, an average of 1 year3
LV ejection fraction
As defined on cardiac MRI (%). Cardiac performance
Time frame
through study completion, an average of 1 year4
Global native myocardial T1 times
As defined on cardiac MRI (ms). Measure of myocardial fibrosis
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov