Status:
COMPLETED
Immune Correlates of Cardiac Structure and Function
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Perinatal HIV Infection
Cardiac Fibrosis
Eligibility:
All Genders
20-45 years
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 co...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 21 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05328713
Start Date
May 9 2022
End Date
September 21 2022
Last Update
March 21 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Health System
Durham, North Carolina, United States, 27710