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NCT Number: NCT03238755

Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins: a Cardiac MRI Study

In this study, investigators plan to test whether statins can preserve and/or improve diastolic function among asymptomatic persons with HIV who are on anti-retroviral therapy. Both myocardial fibrosis and myocardial steatosis are thought to contribute to diastolic dysfunction and eventually overt heart failure in HIV. HIV-positive participants will undergo cardiac MRI/MRS imaging studies for the evaluation of myocardial fibrosis and myocardial steatosis prior to initiation of statin or placebo therapy and then two years after initiation of statin or placebo therapy. Traditional markers of cardiovascular (CVD) risk, systemic immune activation/ inflammation, HIV-specific parameters (i.e. CD4 count), and markers of myocardial stretch/injury will be assessed in relation to cardiac MRI/MRS outcomes.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cape Town, Cape Town, South Africa

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • New enrollment in the REPRIEVE Trial

Exclusion criteria

  • clinical diagnosis of HFpEF or HFrEF, by subject report
  • standard contraindications to MRI procedure based on MRI Patient Procedure Screening Form - including history of severe allergy to gadolinium

Treatment and study plan

Cardiac MRI/MRS

Other

whole blood, plasma, and serum

Primary outcomes

  1. Extracellular Volume (ECV), a measure of myocardial fibrosis on Cardiac MRI

    Time frame: Two years

Secondary outcomes

  1. Diastolic function on Cardiac MRI

    Time frame: Two years

Other outcomes

  1. Myocardial Inflammation on Cardiac MRI

    Time frame: Two Years

  2. Intramyocardial fat on Cardiac MRI/MRS

    Time frame: Two Years

  3. Diastolic function on Cardiac MRI

    Time frame: Two Years

  4. Visceral Adiposity on MRS

    Time frame: Two Years

  5. Biomarkers (inflammation/ immune markers, hormonal markers) and markers of myocardial stretch

    Time frame: Two Years

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2026
First posted
Aug 3, 2017
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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