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

September 6, 2023 updated by: Tomas G. Neilan, MD, Massachusetts General Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

129

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Cape Town, South Africa
        • University of Cape Town
  • United States
    • California
      • Los Angeles, California, United States, 90073
        • VA Medical Center-Los Angeles
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Texas
      • Dallas, Texas, United States, 75235
        • UTSW Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

HIV-infected subjects on ART from the community

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Statin group
HIV-infected individuals receiving statin therapy for the duration of the study
Other: Cardiac MRI/MRS
whole blood, plasma, and serum
Placebo group
HIV-infected individuals receiving placebo therapy for the duration of the study
Other: Cardiac MRI/MRS
whole blood, plasma, and serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Extracellular Volume (ECV), a measure of myocardial fibrosis on Cardiac MRI
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Diastolic function on Cardiac MRI
Time Frame: Two years
Two years

Other Outcome Measures

Outcome Measure
Time Frame
Myocardial Inflammation on Cardiac MRI
Time Frame: Two Years
Two Years
Intramyocardial fat on Cardiac MRI/MRS
Time Frame: Two Years
Two Years
Diastolic function on Cardiac MRI
Time Frame: Two Years
Two Years
Visceral Adiposity on MRS
Time Frame: Two Years
Two Years
Biomarkers (inflammation/ immune markers, hormonal markers) and markers of myocardial stretch
Time Frame: Two Years
Two Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2017

Primary Completion (Actual)

June 22, 2022

Study Completion (Estimated)

April 23, 2024

Study Registration Dates

First Submitted

August 1, 2017

First Submitted That Met QC Criteria

August 1, 2017

First Posted (Actual)

August 3, 2017

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016P001999

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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