Heart Function in HIV-Negative Children Exposed to HIV and HAART
Left Ventricular Function in HIV-Negative Children Exposed to HIV and HAART In Utero
調査の概要
状態
条件
詳細な説明
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).
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Missouri
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St. Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
|---|
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Healthy Control
HIV-negative children born to healthy, HIV-negative women
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Exposed to HIV/HAART
HIV-negative children exposed to HIV and HAART in utero
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Left Ventricular Mass Index
時間枠:Baseline
|
left ventricular mass index measured by 2D echocardiography
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Baseline
|
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Fractional Shortening
時間枠:Baseline
|
Fractional shortening measured by M-mode cardiography
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Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Global Strain Rate
時間枠:Baseline
|
Myocardial deformation (a measure of heart contractility) measured by speckel tracking echocardiography
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Baseline
|
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Systolic Myocardial Velocity During Systole (S')
時間枠:Baseline
|
Systolic myocardial velocity during systole measured by tissue Doppler echocardiography
|
Baseline
|
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Early to Late Diastolic Filling Ratio
時間枠:Baseline
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Early to late diastolic filling ratio measured by tissue Doppler echocardiography
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Baseline
|
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Myocardial Wall Velocity During Early Diastole
時間枠:Baseline
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Myocardial wall velocity during early diastolemeasured by tissue Doppler imaging
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Baseline
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協力者と研究者
協力者
捜査官
- 主任研究者:William T Cade, PhD、Washington University School of Medicine
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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