Immune Correlates of Cardiac Structure and Function

NCT05328713 | Completed

• 2 other identifiers: Pro001097011R56HL152803-01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal HIV Infection; Cardiac Fibrosis; Cardiac Inflammation

Outcome Measures

Primary Outcomes (1)

• Myocardial fibrosis by cardiac magnetic resonance (CMR) imaging

  Compare myocardial fibrosis for HIV+ and control subjects (unit = percentage)

  Baseline Visit

Secondary Outcomes (4)

• Cardiac function evaluated using cine cardiac magnetic resonance imaging

  Baseline Visit

• Myocardial edema evaluated using native T2 mapping cardiac magnetic resonance imaging

  Baseline Visit

• Diffuse fibrosis evaluated using native T1 mapping cardiac magnetic resonance imaging

  Baseline Visit

• Extra-cellular volume (ECV) cardiac magnetic resonance imaging

  Baseline Visit

Study Arms (2)

Prospective group with perinatally acquired HIV infection from Duke University Health System clinics

Diagnostic Test: Cardiac MRI

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

Interventions

Cardiac MRI DIAGNOSTIC_TEST

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

Prospective group with perinatally acquired HIV infection from Duke University Health System clinics

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 38439093 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood collected for storage for future proteomic profiling

Study Officials

• Gerald Bloomfield, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 14, 2022
• Study Start: May 9, 2022
• Primary Completion: September 21, 2022
• Study Completion: September 21, 2022
• Last Updated: March 21, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)