Immune Correlates of Cardiac Structure and Function

Study Overview
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Brief Summary
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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.

Official Title
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Immune Correlates of Cardiac Structure and Function

Conditions
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Perinatal HIV Infection, Cardiac Fibrosis, Cardiac Inflammation

Intervention / Treatment
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* Diagnostic Test: Cardiac MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals 20-45 years of age Willingness and ability to provide signed and dated written informed consent, prior to any study-related procedures Diagnosed with HIV <10 years of age or physician confirmation of perinatal HIV infection On antiretroviral treatment (ART) for at least the last greater than or equal to 6 months Willingness to undergo Cardiovascular magnetic resonance imaging (CMR) Willingness to undergo echocardiogram (ECHO) (may be included if ECHO has been done at Duke in the previous 24 months). Willingness to have research blood draw Exclusion Criteria: Contraindication to CMR (metal fragments in eyes or face, implanted electronic devices such as pacemakers, defibrillators, cochlear implants, or nerve stimulators, aneurysm clips) Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 History of anaphylactic reaction to gadolinium contrast Inability to complete an MRI scan in the past due to anxiety Recent acute medical illness resulting in recent hospitalization (in past 90 days) History of: Coronary artery disease (CAD), Myocardial infarction (MI), moderate-severe valvular disease, congenital heart disease, heart failure, non-ischemic CM, Atrial fibrillation/flutter, implantable cardioverter defibrillator (ICD)/pacemaker, myocarditis prior Current Symptoms of Shortness of breath, severe chest pain, palpations, difficulty breathing on exertion, swelling of legs Known to be pregnant or current breastfeeding Known to be on hemodialysis Inability to breath hold for 5-10 seconds Known to have an ejection fraction <45% in the past 24 months Active cancer or cancer chemotherapy or radiation treatment in the prior year. Comorbid inflammatory disease, specifically treated for rheumatoid arthritis (RA) or lupus (SLE) Chronic use of steroids or anti-inflammatory therapy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective group with perinatally acquired HIV infection from Duke University Health System clinics<br> | Diagnostic Test: Cardiac MRI<br>* This study will use Cardiac MRI to identify subclinical cardiac dysfunction.<br>|
| Control retrospective group<br>A retrospective age- and sex-matched HIV-uninfected comparator group from Duke University Health System (DUHS) electronic health record (EHR) and imaging database systems | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial fibrosis by cardiac magnetic resonance (CMR) imaging | Compare myocardial fibrosis for HIV+ and control subjects (unit = percentage) | Baseline Visit | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |