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临床试验/NCT00633815
NCT00633815已完成不适用

Study of Upright Versus Supine Exercise Testing in Fontan-palliated Patients, Compared With Healthy Controls, to Evaluate for Postural Effects on Exercise Parameters

University of Michigan1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2008年1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
45
试验地点
1
主要终点
Exercise Capacity

研究概览

简要总结

Fontan-palliated patients comprise an interesting group of single-ventricle patients who are dependent upon passive return of blood from the body to the lungs. Systemic venous pressures are therefore quite elevated, and one study demonstrated that venous capacitance was diminished. In addition, these patients have markedly diminished aerobic capacity (Max VO2). Although one recent study demonstrated that Fontan patients can increase their Max VO2 through diligent cardiac rehabilitation, their ultimate results were still well below average.

It has previously been described that normal, healthy subjects have decreased exercise performance in a supine vs upright position. However, due to high venous pressures and the need for systemic venous return to overcome gravity in order to perfuse the lungs, one might hypothesize that Fontan patients would have increased exercise performance in a supine vs upright position. The investigators are interested in studying this hypothesis.

研究设计

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

入排标准

年龄范围
8 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • S/p Fontan palliation > 2 years prior
  • Age 8 to 30 years

排除标准

  • Pacemaker dependence
  • Severe hypoxemia (O2 saturation <80%)
  • Recent atrial flutter or other arrhythmias
  • Protein losing enteropathy (PLE)
  • Severe atrioventricular valve regurgitation
  • History of cardiac arrest
  • Significant comorbidities (renal failure, asthma, etc).

结局指标

主要结局

Exercise Capacity

时间窗: 40 minutes

Watts

次要结局

  • Peak Pulmonary Artery Pressure(40 minutes)
  • Peak Oxygen Volume (Peak VO2)(40 minutes)
  • Peak Heart Rate(40 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bryan Goldstein

Fellow, Pediatric Cardiology

University of Michigan

研究点 (1)

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