NCT01721564已完成不适用
Pulmonary Artery Remodelling With Bosentan
Prof David S Celermajer0 个研究点目标入组 8 人开始时间: 2006年4月最近更新:
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
- 发起方
- 入组人数
- 8
- 主要终点
- Acetylcholine Vascular Reactivity Response
研究概览
简要总结
6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pulmonary arterial hypertension; idiopathic and connective tissue disease associated
- •Confirmed or invasive haemodynamic:
- •Mean pulmonary arterial pressure greater than or equal to 25 millimeters of mercury
- •Pulmonary capillary wedge pressure less than 15 millimeters of mercury
- •No prior pulmonary hypertension specific therapy
- •Ability to provide informed consent
排除标准
- •Contra-indications to medications used to test endothelial function; acetylcholine, sodium nitroprusside, NG-Monomethyl-L-Arginine, L-arginine
- •Advanced renal disease
- •Previous allergic reaction to contrast agents
研究组 & 干预措施
Bosentan
Experimental
62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
干预措施: Bosentan (Drug)
结局指标
主要结局
Acetylcholine Vascular Reactivity Response
时间窗: Baseline and 6 months
Percent pulmonary flow change from baseline after acetylcholine
次要结局
- Intravascular Ultrasound - Pulmonary Artery Wall Thickness(baseline and 6 months)
研究者
Prof David S Celermajer
Scandrett Professor of Cardiology
Royal Prince Alfred Hospital, Sydney, Australia
相似试验
终止
4 期
Effects of Bosentan on Respiratory MechanicsPulmonary HypertensionNCT00679068IRCCS Azienda Ospedaliero-Universitaria di Bologna4
Unknown
1 期
Bosentan for Severe Mitral Valve DysfunctionSECONDARY PULMONARY HYPERTENSIONCHILDHOOD RHEUMATOID FEVERCONGESTIVE HEART FAILUREMITRAL STENOSISNCT01270750General Hospital of Chalkida10
撤回
4 期
Combined Use of Angiography, Optical Coherence Tomography and Intravascular Ultrasound in Evaluation of Pulmonary Vascular Structure and Function in Patients With Pulmonary Arterial Hypertension Treated With Oral BosentanPulmonary Arterial HypertensionNCT01508780Massachusetts General Hospital
进行中（未招募）
1 期
BOsentan for Mild Pulmonary vascular disease in Asd patients (the BOMPA trial): a double-blind, randomized controlled, pilot trial - BOMPA trialEUCTR2010-020209-33-BEniversity Hospitals Leuven20
尚未招募
不适用
BICYCLE trial.NL-OMON20429Academic Medical Center - University of Amsterdam40