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

8. juni 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

5 år til 12 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Left Ventricular Mass Index
Tidsramme: Baseline
left ventricular mass index measured by 2D echocardiography
Baseline
Fractional Shortening
Tidsramme: Baseline
Fractional shortening measured by M-mode cardiography
Baseline

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: William T Cade, PhD, Washington University School of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2010

Primær færdiggørelse (Faktiske)

1. december 2011

Studieafslutning (Faktiske)

1. december 2011

Datoer for studieregistrering

Først indsendt

19. april 2010

Først indsendt, der opfyldte QC-kriterier

19. april 2010

Først opslået (Skøn)

21. april 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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