EUCTR2008-004533-21-NL进行中（未招募）不适用
The role of Bosentan in fontan patients: improvement of aerobic capacity - bosentan in fontan patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ICI
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All adult Fontan patients are potentially eligible for this study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients are not eligible for this study if the following inclusion criteria apply:
- •- Systemic arterial pressure < 85 mmHg
- •- Incapable of giving informed consent
- •- Hypersensitivity to bosentan or any of its help substances
- •- Current treatment with bosentan or treatment for pulmonary arterial hypertension
- •- Moderate to severe liver disease: Child-Pugh class B or C
- •- Raised plasma transaminases level > three times limiting value.
- •- Simultaneous use of cyclosporine A
- •- Pregnant or nursing women (a pregnancy test is offered to every female patient within the fertile age)
- •- Desire to have children within the study period or women who do not use reliable contraceptive methods
研究者
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