Immune Correlates of Cardiac Structure and Function

Completed

• Conditions: Perinatal HIV Infection; Cardiac Inflammation; Cardiac Fibrosis
• Interventions: Diagnostic Test: Cardiac MRI

• Registration Number: NCT05328713
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-14
• Study Start: 2022-05-09
• Primary Completion: 2022-09-21
• Study Completion: 2022-09-21
• Status Verified: 2022-10
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective group with perinatally acquired HIV infection from Duke University Health System clinics	Cardiac MRI	-

Primary Outcome Measures

Name	Time	Method
Myocardial fibrosis by cardiac magnetic resonance (CMR) imaging	Baseline Visit	Compare myocardial fibrosis for HIV+ and control subjects (unit = percentage)

Secondary Outcome Measures

Name	Time	Method
Cardiac function evaluated using cine cardiac magnetic resonance imaging	Baseline Visit	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)
Myocardial edema evaluated using native T2 mapping cardiac magnetic resonance imaging	Baseline Visit	Compare native T2 mapping values for HIV+ and control subjects (unit = ms)
Diffuse fibrosis evaluated using native T1 mapping cardiac magnetic resonance imaging	Baseline Visit	Compare native T1 mapping values for HIV+ and control subjects (unit = ms)
Extra-cellular volume (ECV) cardiac magnetic resonance imaging	Baseline Visit	Compare ECV for HIV+ and control subjects (unit=percentage)

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States