EUCTR2006-002907-15-GB进行中（未招募）1 期
Multicenter, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of tezosentan in patients with pre-operative pulmonary hypertension, due to left heart disease, undergoing cardiac surgery
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 270
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
入选标准
- •·Patients >=18 years of age
- •·Male or female patients (females of child-bearing potential must have been surgically sterilized or use a reliable method of contraception).
- •·Patients undergoing complex* cardiac surgery on CPB and having sPAP > 40 mmHg or mPAP > 30 mmHg (measured by RHC or echocardiography at screening).
- •* Complex cardiac surgery is defined as:
- •oSurgery on two valves
- •oSurgery on one valve plus revascularization
- •oRe-operation of previous valve surgery.
- •Patients undergoing cardiac surgery on CPB and having pre-operative pulmonary hypertension due to left heart disease (measured by RHC or echocardiography at screening) defined as
- •osPAP > 60 mmHg with mPAP/MAP > 0.5
- •osPAP > 60 mmHg with signs and/or symptoms of right ventricular dysfunction.
- •·Signed informed consent prior to any study-mandated procedure.
- •MAP = mean arterial pressure; mPAP = mean pulmonary arterial pressure; sPAP = systolic pulmonary arterial pressure; RHC = right heart catheterization.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Sitting systolic blood pressure < 100 mmHg (measured at hospital admission).
- •·Significant chronic lung disease that might interfere with the ability to interpret the study results (e.g., severe chronic obstructive pulmonary disease).
- •·Emergency surgery.
- •·Pregnant or breast-feeding females.
- •·Use of another investigational drug within 28 days prior to randomization.
- •·Complex adult congenital heart disease.
- •·Severe concomitant illness limiting life expectancy (< 6 months).
- •·Participation in a device study that will affect the outcome of the study.
- •·Pre-operative use of balloon pump.
- •·Pre-operative use of inotropes/vasopressor drugs.
- •·Pre-operative treatment of pulmonary arterial hypertension (PAH).
- •·Known hypersensitivity to tezosentan or drugs of the same class, or any of their excipients.
- •·Severe liver impairment.
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