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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03238755
• Other study ID #: 2016P001999
• Status: Active, not recruiting
• Start date: July 31, 2017
• Est. completion date: April 23, 2024

Study information

• Verified date: September 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 129
• Est. completion date: April 23, 2024
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Other:
• Cardiac MRI/MRS
whole blood, plasma, and serum

Locations

Country	Name	City	State
South Africa	University of Cape Town	Cape Town
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	UTSW Medical Center	Dallas	Texas
United States	VA Medical Center-Los Angeles	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Myocardial Inflammation on Cardiac MRI		Two Years
Other	Intramyocardial fat on Cardiac MRI/MRS		Two Years
Other	Diastolic function on Cardiac MRI		Two Years
Other	Visceral Adiposity on MRS		Two Years
Other	Biomarkers (inflammation/ immune markers, hormonal markers) and markers of myocardial stretch		Two Years
Primary	Extracellular Volume (ECV), a measure of myocardial fibrosis on Cardiac MRI		Two years
Secondary	Diastolic function on Cardiac MRI		Two years