Immune Correlates of Cardiac Structure and Function

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Fibrosis; Cardiac Inflammation; Perinatal HIV Infection
• Intervention / Treatment: Diagnostic test: Cardiac MRI

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Recruitment will be from Adult or Pediatric Infectious Disease (ID) Clinics at DUHS and other clinic sites where Duke providers deliver care for HIV.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective group with perinatally acquired HIV infection from Duke University Health System clinics	Diagnostic test: Cardiac MRI; This study will use Cardiac MRI to identify subclinical cardiac dysfunction.
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Gerald Bloomfield, MD, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Actual): September 21, 2022
• Study Completion (Actual): September 21, 2022

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: Pro00109701; 1R56HL152803-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No