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NCT06784154Recruiting

The Role of Ectopic Fat and Heart Attack Risk in HIV

The Association of Ectopic Fat and Cardiovascular Disease in People Living With HIV and General Populations: A Cross Sectional Analysis

Source: ClinicalTrials.gov · Last updated 19 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
30 Jan 2024
Start date
1 Aug 2024
Primary completion date
30 Jun 2027
Lead sponsor
University of Liverpool
Diseases
HIV
NCT number
NCT06784154

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 1 Aug 2024 to the primary completion date, 30 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Active illicit intravenous drug use
  • Subjects currently taking: Atypical antipsychotics, omega 3 supplements, Telmisartan/Irbesartan, Thiazolidinediones or regular NSAID use.

Other illness

  • 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

Lab values

  • History of severe renal impairment (eGFR \<30ml/min)

Other

  • Subjects unable to comply with the study protocol
  • 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.
  • Familial hypercholesterolaemia

Who the study is looking for

  • • \>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

Age in the registry: 40 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Royal Liverpool University Hospital
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LiverpoolUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.