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

Active, not recruiting

• Conditions: HIV Infections
• Interventions: Other: Cardiac MRI/MRS

• Registration Number: NCT03238755
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-31
• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-03
• Primary Completion: 2022-06-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Study Completion: 2026-04-23

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 129

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo group	Cardiac MRI/MRS	HIV-infected individuals receiving placebo therapy for the duration of the study
Statin group	Cardiac MRI/MRS	HIV-infected individuals receiving statin therapy for the duration of the study

Primary Outcome Measures

Name	Time	Method
Extracellular Volume (ECV), a measure of myocardial fibrosis on Cardiac MRI	Two years

Secondary Outcome Measures

Name	Time	Method
Diastolic function on Cardiac MRI	Two years

Trial Locations

Locations (4)

UTSW Medical Center; 🇺🇸 Dallas, Texas, United States

University of Cape Town; 🇿🇦 Cape Town, South Africa

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

VA Medical Center-Los Angeles; 🇺🇸 Los Angeles, California, United States