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OpenTrials
Completed

NCT Number: NCT05328713

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.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Cardiac MRI

Diagnostic Test

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

Primary outcomes

  1. Myocardial fibrosis by cardiac magnetic resonance (CMR) imaging

    Time frame: Baseline Visit

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

Secondary outcomes

  1. Cardiac function evaluated using cine cardiac magnetic resonance imaging

    Time frame: 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)

  2. Myocardial edema evaluated using native T2 mapping cardiac magnetic resonance imaging

    Time frame: Baseline Visit

    Compare native T2 mapping values for HIV+ and control subjects (unit = ms)

  3. Diffuse fibrosis evaluated using native T1 mapping cardiac magnetic resonance imaging

    Time frame: Baseline Visit

    Compare native T1 mapping values for HIV+ and control subjects (unit = ms)

  4. Extra-cellular volume (ECV) cardiac magnetic resonance imaging

    Time frame: Baseline Visit

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2022
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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