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临床试验/NCT00571233
NCT00571233已完成不适用

Identification of Biomarkers for Heart Failure in Children With Single Ventricle Physiology

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2007年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
71
试验地点
1
主要终点
Heart failure, as assessed by clinical scoring systems.

研究概览

简要总结

The purpose of this study is to determine if children with heart disease where there is only one pumping chamber("ventricle") have proteins (biomarkers") in the blood that can be used to monitor the function of their heart.

详细描述

We will investigate whether levels of blood proteins in children with well-functioning hearts with one ("single") ventricle are similar to levels of these blood proteins in children with two ventricles. For children with hearts with a single ventricle, we will examine blood proteins at various levels of heart function. To assess blood protein levels, we will collect small (6 mL) samples of blood. Heart function will be determined by existing clinical scoring systems. Enrolled patients will receive an echocardiogram, which is a dynamic ultrasound picture of the beating heart.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
1 Month 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with a structurally normal heart and a patent ductus arteriosus.
  • Children with single ventricle physiology.

排除标准

  • Children must not have chromosomal abnormalities. Small deletions, such as that which produces DiGeorge syndrome, are permissible.
  • Children with acute intercurrent non-cardiac inflammatory illness (such as post-operative wound infection) are ineligible, as such conditions may cause elevated blood levels of the proteins under study.

结局指标

主要结局

Heart failure, as assessed by clinical scoring systems.

时间窗: Cross-sectional. We will obtain blood samples and assess for heart failure (function) concurrently when patients present to the Pediatric Heart Center

次要结局

  • Echocardiographic indices.(Cross-sectional)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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