Everolimus in der Therapie von Patienten mit pulmonaler Hypertonie

niversität Leipzig0 sites10 target enrollmentNovember 15, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
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
Sponsor: niversität Leipzig
Enrollment: 10
Status: Active, not recruiting
Last Updated: 13 years ago

No summary available.

Registry

who.int

Start Date

November 15, 2006

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversität Leipzig

•\- 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

•\- 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