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临床试验/NCT01169519
NCT01169519已完成1 期

Safety, Pharmacokinetics and Hemodynamic Efficacy of Sildenafil in Single Ventricle Patients

Duke University1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
21
试验地点
1
主要终点
Maximum Sildenafil Plasma Concentration

研究概览

简要总结

Patients with single ventricle anatomy undergo staged surgical palliation. The result is an "in series" circulation with pulmonary blood flow and cardiac output directly related to pulmonary vascular resistance. While surgical outcomes have improved, the physiology of the single ventricle palliation results in continued long term attrition. Elevated pulmonary vascular resistance and impaired systemic ventricular function are important risk factors for failure of single ventricle palliation.

Sildenafil is a pulmonary vasodilator and has been shown to improve cardiac contractility in the pressure overloaded right ventricle.

The investigators will assess the safety, pharmacokinetics and hemodynamic efficacy of sildenafil in single ventricle patients following stage II and III surgical palliation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Months 至 120 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 3 months; ≤120 months.
  • History of congenital heart disease with severe hypoplasia of a right or left ventricle.
  • Undergoing cardiac catheterization as part of standard clinical care.
  • Availability and willingness of the parent/legally authorized representative to provide written informed consent.

排除标准

  • History of serious adverse event related to sildenafil administration.
  • History of sildenafil exposure within 48 hours of the study.
  • Presence of pulmonary venous obstruction.
  • Treatment with organic nitrates or alpha blockade therapy.
  • Contraindication to cardiac catheterization as determined by the attending cardiologist and including:
  • Significant hemodynamic instability.
  • Need for Extra-Corporeal Membrane Oxygenation (ECMO) support.
  • Venous occlusion precluding adequate access.
  • Recent systemic illness.
  • Renal failure defined as serum creatinine > 2 times higher than the upper limit of normal.
  • Liver dysfunction defined as alanine aminotransferase or aspartate aminotransferase > 3 times higher than the upper limit of normal.
  • Thrombocytopenia defined as a platelet count < 50 000 cells/µL.
  • Leukopenia defined as white blood cells < 2500 cells/µL.

研究组 & 干预措施

Sildenafil

Active Comparator

Pharmacokinetic and hemodynamic evaluation following sildenafil administration

干预措施: Sildenafil by injection (Drug)

结局指标

主要结局

Maximum Sildenafil Plasma Concentration

时间窗: 5 minutes after completion of sildenafil infusion

Assessment of peak sildenafil plasma concentration.

次要结局

  • Hemodynamic Safety and Efficacy(10 minutes after completion of sildenafil infusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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