HIV Infections
Conditions
Keywords
HIV, Diastolic Dysfunction, Myocardial fibrosis, Statin
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.
Interventions
OTHERCardiac MRI/MRS
whole blood, plasma, and serum
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extracellular Volume (ECV), a measure of myocardial fibrosis on Cardiac MRI | Two years |
Secondary
| Measure | Time frame |
|---|---|
| Diastolic function on Cardiac MRI | Two years |
Other
| Measure | Time frame |
|---|---|
| Diastolic function on Cardiac MRI | Two Years |
| Myocardial Inflammation on Cardiac MRI | Two Years |
| Biomarkers (inflammation/ immune markers, hormonal markers) and markers of myocardial stretch | Two Years |
| Visceral Adiposity on MRS | Two Years |
| Intramyocardial fat on Cardiac MRI/MRS | Two Years |
Countries
South Africa, United States
Outcome results
None listed