NCT00989911已完成不适用
Endothelin Blockade in Patients With Single Ventricle Physiology
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months
研究概览
简要总结
Recent studies have shown beneficial effects of sildenafil in patients with single ventricle congenital heart disease. The purpose of this study is to determine whether Bosentan, a drug with similar effects, will have similar benefit in this patient population.
详细描述
Patients enrolled in the study will take Bosentan. Baseline and follow up measurements will be collected then analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 12 years of age
- •Single ventricle congenital heart disease
- •Require cardiac magnetic resonance imaging (MRI) for clinical purposes.
排除标准
- •< 12 years of age
- •Pregnancy or women who may become pregnant (sexually active and unwilling to use birth control)
- •Patients taking cyclosporin or glyburide
- •Patients with baseline liver dysfunction (aspartate aminotransferase or alanine aminotransferase > 3 times upper limit of normal)
- •Contraindications to MRI (including pacemakers)
- •Use of Bosentan within one month prior to enrollment
研究组 & 干预措施
Bosentan
Experimental
Bosentan
干预措施: Bosentan (Drug)
结局指标
主要结局
Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months
时间窗: 3-6 months
Magnetic resonance imaging-derived aortic flow
次要结局
未报告次要终点
研究者
Jamil Aboulhosn
Assistant Professor of Medicine
University of California, Los Angeles
研究点 (1)
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