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临床试验/NCT00132782
NCT00132782已完成不适用

Relationship Between Functional Health Status and Ventricular Performance After Fontan (A Trial Conducted by the Pediatric Heart Network)

Carelon Research0 个研究点目标入组 546 人开始时间: 2003年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
546

研究概览

简要总结

The purpose of this cross-sectional study was to determine the interrelationships between health status and measures of cardiac performance in children 6 to 18 years of age with congenital heart disease who have undergone a Fontan procedure as surgical treatment for functional single ventricle. The goal was to develop a data set that will permit identification of a clinically relevant endpoint for subsequent trials of medical management of the Fontan patient.

详细描述

BACKGROUND:

Children born with one functional ventricle and who undergo a Fontan procedure, have a higher incidence of late complications than other congenital heart patients. While the Fontan procedure results in restoring near-normal systemic oxygen saturation, there are recognized problems and little information about the overall health status, functional status and ventricular performance in these children.

DESIGN NARRATIVE:

This cross-sectional observational study included children 6-18 years of age who had undergone a Fontan procedure for a congenital cardiac defect. Prospective data collection for each patient occured within a 3 month time period and included cardiac MRI, echocardiography, serology and exercise testing. Historical clinical and surgical data, as well as parent and child self reports of health status, was collected.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

发起方
Carelon Research
申办方类型
Other

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