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| ID | Type | Description | Link |
|---|---|---|---|
| 1R56HL152803-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to determine the occurrence of scarring of the heart (cardiac fibrosis) and inflammation in those with perinatally acquired Human Immunodeficiency Virus (HIV) infection compared to people not infected with HIV. The information learned from this research may help the investigator to better understand the link between cardiac fibrosis and cardiac dysfunction and inflammation in those with perinatally acquired HIV infection compared to the uninfected.
Participants will have a blood sample, complete a patient questionnaire, and have a Magnetic resonance imaging (MRI) and ultrasound of the heart.
Researchers will review the medical record and past medical history, for information about your heart function and overall health. Research samples and data from this study will be stored indefinitely and used for other research.
There are risks to participate in this study and those risks include side effects from the contrast agent used for the MRI scan, (such as headache and injection site pain), and risks from blood sampling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective group with perinatally acquired HIV infection from Duke University Health System clinics |
| ||
| Control retrospective group | A retrospective age- and sex-matched HIV-uninfected comparator group from Duke University Health System (DUHS) electronic health record (EHR) and imaging database systems |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac MRI | Diagnostic Test | This study will use Cardiac MRI to identify subclinical cardiac dysfunction. |
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| Measure | Description | Time Frame |
|---|---|---|
| Myocardial fibrosis by cardiac magnetic resonance (CMR) imaging | Compare myocardial fibrosis for HIV+ and control subjects (unit = percentage) | Baseline Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac function evaluated using cine cardiac magnetic resonance imaging | Compare Left ventricular ejection fraction (LVEF) for HIV+ and control subjects (unit = percentage) Compare left ventricle (LV) mass for HIV+ and control subjects (unit = grams) | Baseline Visit |
| Myocardial edema evaluated using native T2 mapping cardiac magnetic resonance imaging |
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Inclusion Criteria:
Exclusion Criteria:
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Recruitment will be from Adult or Pediatric Infectious Disease (ID) Clinics at DUHS and other clinic sites where Duke providers deliver care for HIV.
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| Name | Affiliation | Role |
|---|---|---|
| Gerald Bloomfield, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38439093 | Background | Williams JL, Hung F, Jenista E, Barker P, Chakraborty H, Kim R, McCrary AW, Shah SH, Thielman N, Bloomfield GS. Diffuse myocardial fibrosis is uncommon in people with perinatally acquired human immunodeficiency virus infection. AIDS Res Ther. 2024 Mar 4;21(1):13. doi: 10.1186/s12981-024-00598-4. |
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blood collected for storage for future proteomic profiling
Compare native T2 mapping values for HIV+ and control subjects (unit = ms) |
| Baseline Visit |
| Diffuse fibrosis evaluated using native T1 mapping cardiac magnetic resonance imaging | Compare native T1 mapping values for HIV+ and control subjects (unit = ms) | Baseline Visit |
| Extra-cellular volume (ECV) cardiac magnetic resonance imaging | Compare ECV for HIV+ and control subjects (unit=percentage) | Baseline Visit |