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Immune Correlates of Cardiac Structure and Function

Immune Correlates of Cardiac Structure and Function

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05328713
Enrollment
40
Registered
2022-04-14
Start date
2022-05-09
Completion date
2022-09-21
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Fibrosis, Cardiac Inflammation, Perinatal HIV Infection

Brief summary

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.

Interventions

DIAGNOSTIC_TESTCardiac MRI

This study will use Cardiac MRI to identify subclinical cardiac dysfunction.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Duke University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

1. Individuals 20-45 years of age 2. Willingness and ability to provide signed and dated written informed consent, prior to any study-related procedures 3. Diagnosed with HIV \<10 years of age or physician confirmation of perinatal HIV infection 4. On antiretroviral treatment (ART) for at least the last greater than or equal to 6 months 5. Willingness to undergo Cardiovascular magnetic resonance imaging (CMR) 6. Willingness to undergo echocardiogram (ECHO) (may be included if ECHO has been done at Duke in the previous 24 months). 7. Willingness to have research blood draw

Exclusion criteria

1. Contraindication to CMR (metal fragments in eyes or face, implanted electronic devices such as pacemakers, defibrillators, cochlear implants, or nerve stimulators, aneurysm clips) 2. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2 3. History of anaphylactic reaction to gadolinium contrast 4. Inability to complete an MRI scan in the past due to anxiety 5. Recent acute medical illness resulting in recent hospitalization (in past 90 days) 6. 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 7. Current Symptoms of Shortness of breath, severe chest pain, palpations, difficulty breathing on exertion, swelling of legs 8. Known to be pregnant or current breastfeeding 9. Known to be on hemodialysis 10. Inability to breath hold for 5-10 seconds 11. Known to have an ejection fraction \<45% in the past 24 months 12. Active cancer or cancer chemotherapy or radiation treatment in the prior year. 13. Comorbid inflammatory disease, specifically treated for rheumatoid arthritis (RA) or lupus (SLE) 14. Chronic use of steroids or anti-inflammatory therapy

Design outcomes

Primary

MeasureTime frameDescription
Myocardial fibrosis by cardiac magnetic resonance (CMR) imagingBaseline VisitCompare myocardial fibrosis for HIV+ and control subjects (unit = percentage)

Secondary

MeasureTime frameDescription
Cardiac function evaluated using cine cardiac magnetic resonance imagingBaseline VisitCompare Left ventricular ejection fraction (LVEF) for HIV+ and control subjects (unit = percentage) Compare left ventricle (LV) mass for HIV+ and control subjects (unit = grams)
Myocardial edema evaluated using native T2 mapping cardiac magnetic resonance imagingBaseline VisitCompare native T2 mapping values for HIV+ and control subjects (unit = ms)
Diffuse fibrosis evaluated using native T1 mapping cardiac magnetic resonance imagingBaseline VisitCompare native T1 mapping values for HIV+ and control subjects (unit = ms)
Extra-cellular volume (ECV) cardiac magnetic resonance imagingBaseline VisitCompare ECV for HIV+ and control subjects (unit=percentage)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026