NL-OMON40031已完成2 期
Bosentan in Exercise Induced Pulmonary Arterial Hypertension in Congenital Heart Disease - BICYCLE trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •- adult (>18 years) and mentally competent
- •- Open or closed septal defect (ASD I/II, VSD, AVSD)
- •- Open or closed systemic-to-pulmonary shunt (PDA)
- •- Negative pregnancy test
- •- Presence of X-PAH, including one of the following criteria, at peak exercise.
- •* mPAP > 34 mmHg with CO <= 10 l/min
- •* mPAP > 40 mmHg with CO <= 15 l/min
- •* mPAP > 45 mmHg with CO <= 20 l/min
- •* mPAP > 50 mmHg with CO <= 30 l/min
- •* PVR (slope pressure/flow plot) of > 2.5 mmHg/l/min during exercise
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •- Incapable of giving informed consent
- •- Pregnancy or lactation (a pregnancy test is offered to every female patient within fertile age)
- •- Women of child-bearing age who are sexually active without practising reliable methods of contraception. The use of oral contraceptives only, is not considered reliable.
- •- Substance abuse (alcohol, medicines, drugs)
- •- Subjects who are not able to perform cardiopulmonary exercise testing
- •- Any cardiac operation <6 months before inclusion
- •- PAH of any aetiology other than the one specified in the inclusion criteria
- •- Left ventricular ejection fraction < 30%
- •- Significant impairment of renal function (GFR < 30 ml/min/1.73m2)
- •- Moderate to severe liver disease: Child Pugh class B or C
- •- Raised plasma transaminases level > three times upper normal limit
- •- Arterial hypotension (systolic blood pressure < 85mmHg)
- •- Anaemia (Hb < 10g/L, or <6.21 mmol/L)
- •- Significant valvular disease, other than tricuspid or pulmonary regurgitation
- •- Chronic lung disease or total lung capacity < 80% predicted value
- •- History of significant pulmonary embolism
- •- Other relevant diseases (HIV infection, Hep B/C infection)
- •- Subjects with known intolerance to bosentan or their constituents
- •- Prohibited medication: any medication listed below which has not been discontinued at least 30 days prior to inclusion
- •o Unspecified or other significant medication (glybenclamide or immunosuppression)
- •o PAH therapy (endothelin receptor antagonists, PDE-5 inhibitors, prostanoids)
- •o Medication which is not compatible with bosentan or interferes with its metabolism (inhibitors or inducers of CYP2C9, CYP3A4) or medication which may interfere with bosentan treatment according to the investigator
研究者
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