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Heart Function in HIV-Negative Children Exposed to HIV and HAART

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
W. Todd Cade, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01107834
First received: April 19, 2010
Last updated: June 8, 2016
Last verified: June 2016
  Purpose
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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Left Ventricular Mass Index [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    left ventricular mass index measured by 2D echocardiography

  • Fractional Shortening [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Fractional shortening measured by M-mode cardiography


Secondary Outcome Measures:
  • Global Strain Rate [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Myocardial deformation (a measure of heart contractility) measured by speckel tracking echocardiography

  • Systolic Myocardial Velocity During Systole (S') [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Systolic myocardial velocity during systole measured by tissue Doppler echocardiography

  • Early to Late Diastolic Filling Ratio [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Early to late diastolic filling ratio measured by tissue Doppler echocardiography

  • Myocardial Wall Velocity During Early Diastole [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Myocardial wall velocity during early diastolemeasured by tissue Doppler imaging


Enrollment: 60
Study Start Date: May 2010
Study Completion Date: December 2011
Primary Completion Date: December 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).

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  1. Age 5-12 years
  2. Tanner stage I-III
  3. Born to HIV+ mother
  4. No HIV infection
  5. Had taken standard of care prophylactic HAART at birth-1 month of age
  6. Child currently not taking medications or have medical diagnosis that would affect left ventricular function
  7. Mother was taking HAART during pregnancy (standard of care)
  8. Mother was not using illegal drugs during pregnancy
  9. No intrauterine growth restriction diagnosis during pregnancy
  10. During pregnancy, mother will not have a diagnosis of type 2 diabetes or gestational diabetes.

Exclusion Criteria:

  1. Age 5-12 years
  2. Tanner stage I-III
  3. Born to HIV-negative mother
  4. Mother was not a frequent exerciser during pregnancy (>2x/week)
  5. Mother will not have gestational diabetes or a diagnosis of type 2 diabetes during pregnancy of the child being studied
  6. Child currently not taking medications or have medical diagnosis that would affect left ventricular function
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107834

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
GlaxoSmithKline
Investigators
Principal Investigator: William T Cade, PhD Washington University School of Medicine
  More Information

Publications:
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 
Study First Received: April 19, 2010
Results First Received: December 16, 2013
Last Updated: June 8, 2016
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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on December 07, 2016