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

NCT03238755 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 129

Last updated 2024-11-21

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infections

Interventions

OTHER

Cardiac MRI/MRS

whole blood, plasma, and serum

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2022-06-22
Completion
2026-04-23
FDA Drug
Yes

Countries

  • United States
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03238755 on ClinicalTrials.gov