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

Mass General Brigham

Status: Active, not recruiting

Conditions: HIV Infections

Treatments: Other: Cardiac MRI/MRS

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03238755

2016P001999

Details and patient eligibility

About

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.

Enrollment: 129 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

129 participants in 2 patient groups

Statin group

Description:

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

Treatment:

Other: Cardiac MRI/MRS

Placebo group

Description:

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

Treatment:

Other: Cardiac MRI/MRS