Heart Function in HIV-Negative Children Exposed to HIV and HAART
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ClinicalTrials.gov Identifier: NCT01107834 |
Recruitment Status
:
Completed
First Posted
: April 21, 2010
Results First Posted
: July 20, 2016
Last Update Posted
: July 20, 2016
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Condition or disease |
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HIV Infections |
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).
Study Type : | Observational |
Actual Enrollment : | 60 participants |
Observational Model: | Case Control |
Time Perspective: | Cross-Sectional |
Official Title: | Left Ventricular Function in HIV-Negative Children Exposed to HIV and HAART In Utero |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |

Group/Cohort |
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Healthy Control
HIV-negative children born to healthy, HIV-negative women
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Exposed to HIV/HAART
HIV-negative children exposed to HIV and HAART in utero
|
- Left Ventricular Mass Index [ Time Frame: Baseline ]left ventricular mass index measured by 2D echocardiography
- Fractional Shortening [ Time Frame: Baseline ]Fractional shortening measured by M-mode cardiography
- Global Strain Rate [ Time Frame: Baseline ]Myocardial deformation (a measure of heart contractility) measured by speckel tracking echocardiography
- Systolic Myocardial Velocity During Systole (S') [ Time Frame: Baseline ]Systolic myocardial velocity during systole measured by tissue Doppler echocardiography
- Early to Late Diastolic Filling Ratio [ Time Frame: Baseline ]Early to late diastolic filling ratio measured by tissue Doppler echocardiography
- Myocardial Wall Velocity During Early Diastole [ Time Frame: Baseline ]Myocardial wall velocity during early diastolemeasured by tissue Doppler imaging

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Ages Eligible for Study: | 5 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age 5-12 years
- Tanner stage I-III
- Born to HIV+ mother
- No HIV infection
- Had taken standard of care prophylactic HAART at birth-1 month of age
- Child currently not taking medications or have medical diagnosis that would affect left ventricular function
- Mother was taking HAART during pregnancy (standard of care)
- Mother was not using illegal drugs during pregnancy
- No intrauterine growth restriction diagnosis during pregnancy
- During pregnancy, mother will not have a diagnosis of type 2 diabetes or gestational diabetes.
Exclusion Criteria:
- Age 5-12 years
- Tanner stage I-III
- Born to HIV-negative mother
- Mother was not a frequent exerciser during pregnancy (>2x/week)
- Mother will not have gestational diabetes or a diagnosis of type 2 diabetes during pregnancy of the child being studied
- Child currently not taking medications or have medical diagnosis that would affect left ventricular function

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107834
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | William T Cade, PhD | Washington University School of Medicine |
Publications of Results:
Responsible Party: | W. Todd Cade, Assistant Professor of Physical Therapy and Medicine, Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT01107834 History of Changes |
Other Study ID Numbers: |
10-0121 |
First Posted: | April 21, 2010 Key Record Dates |
Results First Posted: | July 20, 2016 |
Last Update Posted: | July 20, 2016 |
Last Verified: | June 2016 |
Keywords provided by W. Todd Cade, Washington University School of Medicine:
HIV heart function HAART in utero children |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |