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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-31

Study Completion Date

2026-04-23

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Statin group

HIV-infected individuals receiving statin therapy for the duration of the study

Cardiac MRI/MRS

Intervention Type OTHER

whole blood, plasma, and serum

Placebo group

HIV-infected individuals receiving placebo therapy for the duration of the study

Cardiac MRI/MRS

Intervention Type OTHER

whole blood, plasma, and serum

Interventions

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Cardiac MRI/MRS

whole blood, plasma, and serum

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No