Heart Function in HIV-Negative Children Exposed to HIV and HAART
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      HIV-uninfected children born to HIV+ women have low level heart problems at birth which may
      predispose them to heart failure, arrythmias and heart attack later in life. The impact of
      these heart problems on future heart health is unclear as it is unknown if heart problems in
      these children persist, worsen or resolve in pre-pubescence. The objective of this study is
      to characterize heart function in HIV-negative pre-pubertal children born to HIV+ women and
      exposed to HIV and HAART in utero and compare them to age and gender matched healthy children
      born to HIV-negative women. Through this objective we will determine if heart problems in
      HIV-negative children born to HIV+ women and exposed to HAART in utero persists, worsens, or
      resolves during pre-pubescence.
    

Detailed description: 
      Significance:

      Approximately 700,000 children annually are born to HIV-infected mothers throughout the
      world, but with the advent of perinatal highly active antiretroviral therapy (HAART), the
      majority of children are born uninfected in Westernized nations and those uninfected are
      increasing in developing nations. Uninfected children exposed to HIV and HAART in utero, have
      subclinical left ventricular dysfunction (LVD) at birth which may predispose them to heart
      failure, conduction abnormalities and myocardial infarction later in life. The impact of this
      LVD on future cardiac risk is unclear as it is unknown if LVD in these children persist,
      worsen or resolve in pre-pubescence.

      Study objectives:

      The objective of this study is to characterize left ventricular function in HIV-negative
      pre-pubertal children born to HIV+ women and exposed to HIV and HAART in utero and compare
      them to age and gender matched healthy children born to HIV-negative women. Through this
      objective we will determine if LVD in HIV-negative children born to HIV+ women and exposed to
      HAART in utero persists, worsens, or resolves during pre-pubescence. If LVD persists or
      worsens in pre-pubescence, these data will lead to future studies examining mechanisms of and
      treatments for LVD in these children and will significantly impact the clinical monitoring
      and care of these children. If LVD resolves during pre-pubescence, then these data will
      provide important information that clinical cardiac monitoring may not be critical in this
      population.

      Methods:

      We plan to examine left ventricular function in 30 HIV-negative children born to HIV+ women
      and exposed to HAART in utero and compare them to 30 healthy age and gender matched children
      born to HIV-negative women. Left ventricular function will be examined by 2-D, Doppler and
      Tissue Doppler imaging echocardiography using a General Electric Vivid 7® ultrasound machine.
      Left ventricular measures will include left ventricular structure and dimensions, systolic
      and diastolic flow rates, wall velocities during systole and diastole and systolic and
      diastolic strain and strain rates (sensitive measures of myocardial contractility).
      Echocardiographic measures will take place in the Cardiovascular Imaging Laboratory (CVIL) at
      Washington University School of Medicine by a certified cardiac ultrasonographer and data
      will be processed, analyzed and interpreted by the ultrasonographer, a consulting
      cardiologist and the principal investigator.

      Outcomes:

      Primary outcomes will include measures of left ventricular function: left ventricular mass,
      left ventricular end diastolic dimension, fractional shortening, systolic and diastolic wall
      velocities (tissue Doppler imaging) and systolic and diastolic strain and strain rates (2-D
      speckle tracking methodology).
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        HIV-negative children will be recruited through their HIV+ mothers who are seen at the AIDS
        Clinical Trials Unit at Washington University and surrounding St. Louis community clinics.
        HIV-negative children will be recruit through Washington University and surrounding St.
        Louis pediatric clinics, and through Washington University Volunteers for Health service.
      
Keywords: HIV; heart function; HAART; in utero; children