Clinical trial NCT05328713: Immune Correlates of Cardiac Structure and Function
Official title: Immune Correlates of Cardiac Structure and Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perinatal HIV Infection
Cardiac Fibrosis
Cardiac Inflammation
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-04-14
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Myocardial fibrosis by cardiac magnetic resonance (CMR) imaging
timeFrame: Baseline Visit
Secondary outcomes:
measure: Cardiac function evaluated using cine cardiac magnetic resonance imaging
timeFrame: Baseline Visit
measure: Myocardial edema evaluated using native T2 mapping cardiac magnetic resonance imaging
timeFrame: Baseline Visit
measure: Diffuse fibrosis evaluated using native T1 mapping cardiac magnetic resonance imaging
timeFrame: Baseline Visit
measure: Extra-cellular volume (ECV) cardiac magnetic resonance imaging
timeFrame: Baseline Visit
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Gerald Bloomfield, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.