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

8 de junho de 2016 atualizado por: W. Todd Cade, Washington University School of Medicine

Left Ventricular Function in HIV-Negative Children Exposed to HIV and HAART In Utero

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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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).

Tipo de estudo

Observacional

Inscrição (Real)

60

Contactos e Locais

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Locais de estudo

    • Missouri
      • St. Louis, Missouri, Estados Unidos, 63110
        • Washington University School of Medicine

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

5 anos a 12 anos (Filho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Left Ventricular Mass Index
Prazo: Baseline
left ventricular mass index measured by 2D echocardiography
Baseline
Fractional Shortening
Prazo: Baseline
Fractional shortening measured by M-mode cardiography
Baseline

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Global Strain Rate
Prazo: Baseline
Myocardial deformation (a measure of heart contractility) measured by speckel tracking echocardiography
Baseline
Systolic Myocardial Velocity During Systole (S')
Prazo: Baseline
Systolic myocardial velocity during systole measured by tissue Doppler echocardiography
Baseline
Early to Late Diastolic Filling Ratio
Prazo: Baseline
Early to late diastolic filling ratio measured by tissue Doppler echocardiography
Baseline
Myocardial Wall Velocity During Early Diastole
Prazo: Baseline
Myocardial wall velocity during early diastolemeasured by tissue Doppler imaging
Baseline

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Colaboradores

Investigadores

  • Investigador principal: William T Cade, PhD, Washington University School of Medicine

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de maio de 2010

Conclusão Primária (Real)

1 de dezembro de 2011

Conclusão do estudo (Real)

1 de dezembro de 2011

Datas de inscrição no estudo

Enviado pela primeira vez

19 de abril de 2010

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de abril de 2010

Primeira postagem (Estimativa)

21 de abril de 2010

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

20 de julho de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de junho de 2016

Última verificação

1 de junho de 2016

Mais Informações

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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