Heart Function in HIV-Negative Children Exposed to HIV and HAART
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
![](https://webarchive.library.unt.edu/web/20130305102820im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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.
Condition |
---|
HIV Infections |
Study Type: | Observational |
Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
Official Title: | Left Ventricular Function in HIV-Negative Children Exposed to HIV and HAART In Utero |
- Measures of heart function by echocardiography [ Time Frame: every 6 months ] [ Designated as safety issue: No ]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)
Estimated Enrollment: | 60 |
Study Start Date: | May 2010 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
---|
Healthy Control
HIV-negative children born to healthy, HIV-negative women
|
Exposed to HIV/HAART
HIV-negative children exposed to HIV and HAART in utero
|
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).
![](https://webarchive.library.unt.edu/web/20130305102820im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 5 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
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
![](https://webarchive.library.unt.edu/web/20130305102820im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
United States, Missouri | |
Washington University School of Medicine | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: William Todd Cade, PhD 314-286-1432 tcade@wustl.edu | |
Principal Investigator: William Todd Cade, PhD |
Principal Investigator: | William T Cade, PhD | Washington University School of Medicine |
![](https://webarchive.library.unt.edu/web/20130305102820im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided by Washington University School of Medicine
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | William Todd Cade, Washington University |
ClinicalTrials.gov Identifier: | NCT01107834 History of Changes |
Other Study ID Numbers: | 10-0121 |
Study First Received: | April 19, 2010 |
Last Updated: | March 3, 2011 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
HIV heart function HAART in utero children |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on March 03, 2013