RecruitingNot Applicable

The Role of Ectopic Fat and Heart Attack Risk in HIV

United Kingdom100 participantsStarted 2024-08-01

Plain-language summary

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.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * • \>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) * Understand the study procedures, able to comply with study procedures and voluntarily agree to participate by giving informed written consent Exclusion Criteria: * 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 * Any active illness, which in the opinion of the investigator precludes participation in the study. * History of cancer * Active illicit intravenous drug use * Investigators may decide the subject cannot proceed if there are any relevant other abnormal results in screening assessments * History or current GLP-1 agonist use * For female subjects: pregnancy or breast feeding at screening. * Subjects currently taking: Atypical antipsychotics, omega 3 supplements, Telmisartan/Irbesartan, Thiazolidinediones or regular NSAID use. * Familial hypercholesterolaemia

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Epicardial adipose tissue volume

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT06784154

SponsorUniversity of Liverpool

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-06-30

View on ClinicalTrials.gov More Cardiometabolic Syndrome trials