Everolimus in der Therapie von Patienten mit pulmonaler Hypertonie

niversität Leipzig0 个研究点目标入组 10 人开始时间: 2006年11月15日最近更新: 2012年12月10日

适应症

试验速览

暂无简介。

•- patients with pulmonary arterial or thromboembolic pulmonary
•- Age: 18 – 65 years
•- ongoing vaso dilative therapy with at least two medications approved for the treatment of pulmonary arterial hypertension for at least six months (no dose adjustments over the past three months)
•- steady or progressive pulmonary hypertension associated with at least two of the following parameters associated with a poor prognosis:
•*Cardiac index = 2,1 l/min/m2
•*6 MWD = 380 m
•*systolic RR = 120 mmHg
•*VO2max = 11 l/min/kg
•*SVO2 = 60%
•*Hf = 90/min
•*probabilty for survival of one year = 0,7 following the NIH formular
•- written declaration of consent of the patient
•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) no
•F.1.3.1 Number of subjects for this age range

•- decompensated right ventricular cardiac insufficiency associated with an indication for transplantation or intravenous Iloprost-therapy (a stable, established therapy regimen with intravenous Iloprost does not represent an exclusion criterium)
•- postcapillary pulmonary hypertension (wedge pressure > 11 mmHg)
•- liver cirrhosis CHILD Pugh B und C
•- liver insufficiency
•- Transaminases > 3 times hogher than normal
•- known hypersensitivity to Everolimus or other ingredients of the IMP
•- expected low compliance
•- pregnant or lactating women
•- women with childbearing capacity not using a highly effective method of birth control, defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.
•- participation in other clinical trials

发起方

niversität Leipzig