The Role of Ectopic Fat and Heart Attack Risk in HIV

NCT06784154 | Recruiting

• 1 other identifier: UOL001832
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiometabolic Syndrome; Hiv

Outcome Measures

Primary Outcomes (1)

• Epicardial adipose tissue volume

  Epicardial adipose tissue volume measured by cardiac MRI (mm3). Measurment of fat around the heart

  Through study completion, an average of 1 year

Secondary Outcomes (11)

• Intramyocardial triglyceride

  through study completion, an average of 1 year

• Liver fat percentage

  through study completion, an average of 1 year

• LV ejection fraction

  through study completion, an average of 1 year

• Global native myocardial T1 times

  through study completion, an average of 1 year

• Lipids

  through study completion, an average of 1 year

Study Arms (2)

People living with HIV

Other: Non-interventional

General population

Interventions

Non-interventional OTHER

Non-interventional

People living with HIV

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

50 participants from HIV clinic 50 participants from general population (patients undergoing CT Coronary Angiography for investigation of chest pain)

You may qualify if:

• \>40 years
• HIV-positive
• Stable ART for \>6 months with two VL \<40 copies/ml based on local testing protocols
• Understand the study procedures, able to comply with study procedures and voluntarily agree to participate by giving informed written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liverpool: lead

Study Sites (1)

Royal Liverpool University Hospital

Liverpool, United Kingdom

RECRUITING

Related Publications (22)

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Biospecimen

Retention: SAMPLES WITH DNA

We will be taking whole blood for future research purposes

MeSH Terms

Conditions

Metabolic Syndrome; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: January 20, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

GB (1)