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

8 juin 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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).

Type d'étude

Observationnel

Inscription (Réel)

60

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Missouri
      • St. Louis, Missouri, États-Unis, 63110
        • Washington University School of Medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

5 ans à 12 ans (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Left Ventricular Mass Index
Délai: Baseline
left ventricular mass index measured by 2D echocardiography
Baseline
Fractional Shortening
Délai: Baseline
Fractional shortening measured by M-mode cardiography
Baseline

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Global Strain Rate
Délai: Baseline
Myocardial deformation (a measure of heart contractility) measured by speckel tracking echocardiography
Baseline
Systolic Myocardial Velocity During Systole (S')
Délai: Baseline
Systolic myocardial velocity during systole measured by tissue Doppler echocardiography
Baseline
Early to Late Diastolic Filling Ratio
Délai: Baseline
Early to late diastolic filling ratio measured by tissue Doppler echocardiography
Baseline
Myocardial Wall Velocity During Early Diastole
Délai: Baseline
Myocardial wall velocity during early diastolemeasured by tissue Doppler imaging
Baseline

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Collaborateurs

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2010

Achèvement primaire (Réel)

1 décembre 2011

Achèvement de l'étude (Réel)

1 décembre 2011

Dates d'inscription aux études

Première soumission

19 avril 2010

Première soumission répondant aux critères de contrôle qualité

19 avril 2010

Première publication (Estimation)

21 avril 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

20 juillet 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 juin 2016

Dernière vérification

1 juin 2016

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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