EUCTR2013-001613-33-DE进行中（未招募）不适用
Iloprost for Bridging to Heart Transplantation in Patients with Pulmonary Hypertension and Left Heart Failure - BRIDGE
Thoraxclinic at the University of Heidelberg0 个研究点开始时间: 2013年11月19日最近更新:
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
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
- •- Female and male patients of any racial origin with left heart insufficiency and secondary Pulmonary Hypertension
- •- Having fulfilled his/her 18th birthday on Visit 1 (Day -7 to -1) of the study
- •- Written informed consent (must be available before enrollment in the trial)
- •- Modified WHO functional class III-IV
- •- Pulmonary Hypertension diagnosed by right heart catheter showing:
- •o Baseline mean pulmonary arterial pressure (mPAP) > 25 mmHg
- •o Baseline pulmonary vascular resistance (PVR) > 230 dyn x s x cm-5
- •o Baseline transpulmonary gradient (TPG) > 15 mm Hg
- •- Echocardiogram on Visit 1/Day -7 to -1 consistent with secondary PH, specifically evidence of right ventricular hypertrophy or dilation, and absence of mitral valve stenosis
- •- Patients receiving maximal conventional left heart failure therapy including intensified treatment with diuretics and have been stable for at least 2 months before entering the study
- •- Except for diuretics, vasodilators and antihypertensives, medical treatment should not be expected to change during the entire 12-week study period.
- •- Negative pregnancy test (ß-HCG) at the start of the trial and appropriate contraception throughout the study for women with child-bearing potential
- •- Able to understand and sign the Informed Consent Form
- •- Ability of subject to understand character and individual consequences of the clinical trial
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pulmonary Hypertension of any cause other than permitted in the entry criteria, e.g. concomitantly to portal hypertension, complex congenital heart disease, reversed shunt, HIV infection, suspected pulmonary veno-occlusive disease based on pulmonary oedema during a previous vasoreactivity test or on abnormal findings compatible with that diagnosis (septal lines or pulmonary edema previously detected at high resolution computer tomography), congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
- •- Contraindication for right heart catheterization
- •- Severe lung disease: FEV1/FVC <0.5 and total lung capacity < 70% of the normal value
- •- Any subject who had received any investigational medication within 4 weeks prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study
- •- Any PAH-specific medication (ERAs, PDE-5-I, Prostacyclins) during the last 30 days prior to inclusion (randomization).
- •- Known intolerance to inhalation treatment
- •- Conditions where the effects of inhaled Iloprost on platelets might increase the risk of haemorrhage (e.g. active peptic ulcers, trauma, and intracranial haemorrhage)
- •- Severe coronary heart disease or unstable angina, myocardial infarction within the last six months
- •- Cerebrovascular events (e.g. transient ischemic attack, stroke) within the last 3 months
- •- Active liver disease, porphyria or elevations of serum transaminases >3 x ULN (upper limit of normal) or bilirubin > 1.5 x ULN
- •- Hemoglobin concentration of less than 75 % of the lower limit of normal
- •- Systolic blood pressure < 85 mmHg
- •- History or suspicion of inability to cooperate adequately
- •- Pregnancy and lactation
- •- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
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