Everolimus in der Therapie von Patienten mit pulmonaler Hypertonie

Conditions: -steady or progressive pulmonary hypertension accompanied by 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 of survival for one year = 0,7 following the NIH-formular
MedDRA version: 8.1Level: PTClassification code 10037400Term: Pulmonary hypertension

Registration Number: EUCTR2006-004224-37-DE

Lead Sponsor: niversität Leipzig

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

- 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

Exclusion Criteria

- 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