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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statin group | HIV-infected individuals receiving statin therapy for the duration of the study |
| |
| Placebo group | HIV-infected individuals receiving placebo therapy for the duration of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac MRI/MRS | Other | whole blood, plasma, and serum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Extracellular Volume (ECV), a measure of myocardial fibrosis on Cardiac MRI | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic function on Cardiac MRI | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Inflammation on Cardiac MRI | Two Years | |
| Intramyocardial fat on Cardiac MRI/MRS | Two Years | |
| Diastolic function on Cardiac MRI |
Inclusion Criteria:
Exclusion Criteria:
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HIV-infected subjects on ART from the community
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center-Los Angeles | Los Angeles | California | 90073 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32645158 | Derived | Neilan TG, Nguyen KL, Zaha VG, Chew KW, Morrison L, Ntusi NAB, Toribio M, Awadalla M, Drobni ZD, Nelson MD, Burdo TH, Van Schalkwyk M, Sax PE, Skiest DJ, Tashima K, Landovitz RJ, Daar E, Wurcel AG, Robbins GK, Bolan RK, Fitch KV, Currier JS, Bloomfield GS, Desvigne-Nickens P, Douglas PS, Hoffmann U, Grinspoon SK, Ribaudo H, Dawson R, Goetz MB, Jain MK, Warner A, Szczepaniak LS, Zanni MV. Myocardial Steatosis Among Antiretroviral Therapy-Treated People With Human Immunodeficiency Virus Participating in the REPRIEVE Trial. J Infect Dis. 2020 Jul 9;222(Suppl 1):S63-S69. doi: 10.1093/infdis/jiaa245. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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whole blood, plasma, and serum
| Two Years |
| Visceral Adiposity on MRS | Two Years |
| Biomarkers (inflammation/ immune markers, hormonal markers) and markers of myocardial stretch | Two Years |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| UTSW Medical Center | Dallas | Texas | 75235 | United States |
| University of Cape Town | Cape Town | South Africa |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |