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