EUCTR2007-002774-64-DE进行中（未招募）不适用
Therapy of PAH – Treatment with Sildenafil in Eisenmenger Patients - Sildenafil
Deutsches Herzzentrum Berlin, Kompetenznetz Angeborene Herzfehler0 个研究点目标入组 80 人开始时间: 2007年8月20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
- 入组人数
- 80
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
- •Non-specific
- •1.Written informed consent obtained.
- •2.No participation in another AMG driven study attendancing this treatment protocol
- •1.Age at least 14 years
- •2.Presence of cyanosis with < 93 % arterial oxygen saturation (measured by transcutaneous pulse oximetry)
- •3.Clinical indication for the invasive diagnostic procedures planned for the study is given; this is evaluated on the basis of observation before, during and after medicinal therapy)
- •4.Presence of PAH as diagnosed by invasive methods with
- •Rp:Rs > 0.5 measured at rest, before testing of pulmonary vasodilatory reserve
- •5.One of the following diagnoses:
- •a)non-corrected large congenital shunting defect at atrial, ventricular or arterial level:
- •-combinations thereof.
- •b)Surgically corrected shunting defect (diagnoses as above) with significant residual defect
- •c)Other diagnoses with univentricular physiology/ hemodynamics.
- •Are the trial subjects under 18? yes
- •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
- •Non-specific
- •1.pregnancy or lactation
- •2.women of child-bearing age who are sexually active without practising highly effective methods of contraception
- •3.any diseases or impairment that, in the opinion of the investigator exclude a subject from participation
- •4.substance abuse (alcohol, medicines, drugs)
- •5.other medical, psychological or social circumstances that would adversely affect a patient’s ability to participate reliably in the study or increase the risk to themselves or others if they participated
- •6.insufficient compliance
- •7.missing willingness to storaging and transferring pseudonymous disease data within this study.
- •8.subjects who are not able to perform CPX.
- •1.pulmonary hypertension secondary to any etiology other than those specified in the inclusion criteria
- •2.subjects with known intolerance of NO and iloprost or their constituents
- •3.acute decompensated heart failure within the 7 days before the invasive diagnostic procedure
- •4.clinically significant haemoptysis within the last 6 months
- •5.hemodynamic instability which would represent an unjustifiable risk during testing of pulmonary arterial vasoreagibility
- •6.arterial hypotension (as defined by age-specific values)
- •7.anemia (Hb < 10 g/dl)
- •8.decompensated symptomatic policythemia; (details: 4.2.2. exclusion criteria)
- •9.thrombocytopenia (< 50.000/µl)
- •10.secondary impairment of organic function:
- •-impairment of renal function (GFR < 30 ml/min/1,73 m2 body surface)
- •-impairment of hepatic function (ALT and/or AST > 3 x ULN and bilirubin = 2 mg/dl)
- •11.other sources of pulmonary blood flow which prohibit measurement of the blood flow into the lungs and therefore of the pulmonary vascular resistance:
- •-significant number of MAPCAs; (details: 4.2.2. exclusion criteria)
- •12.Obstruction of pulmonary blood outflow:
- •-obstruction of pulmonary venous return
- •-mitral valve dysfunction
- •13.Left heart diseases:
- •-aortic or mitral valve disease (more severe than mild”)
- •-restrictive or congestive cardiomyopathy
- •-PCWP/LVEDP > 15 mmHg
- •-symptomatic coronary artery disease
- •14.Significant valvular diseases other than tricuspid or pulmonary regurgitation (these are not exclusion criteria; details: 4.2.2. exclusion criteria).
- •15.Pericardial constriction
- •16.History of stroke, myocardial infarction or life-threatening arrhythmia within the 6 months before screening
- •17.Bronchopulmonary dysplasia (BPD) and other chronic lung diseases
- •18.History of significant pulmonary embolism
- •19.Other relevant diseases (e.g. HIV, diabetes mellitus requiring pharmacologic treatment)
- •20.Subjects with trisomy 21 (reproducibility of 6-MWT and CPX doubtful; communication as to side effects and subjective quality of life doubtful)
- •21.all contraindications against the study medication (see also 4.2.3 concomitant medication”)
- •-hypersensitivity against the active ingredients as well as supplementaries
- •-patients who lost vision on one eye due to a non arteriitic anterior ischaemic neuropathy of the opticus (NAION).
- •Prohibited concomitant medication:
- •Any medication listed below which has not been discontinued at least 30 days prior to screening. Specific pulmonary vasodilators during cardiac catheterization are allowed.
- •1.Unspecified concomitant medication
- •2.Other significant medication (e.g. diabetes medication, immunosuppression like glucocorticoids, cytostatics)
- •3.Instable medication (details: 4.2.5 prohibited concomitant medication):
- •-begin of a new medica
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