Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Inoperable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH)
The primary purpose of this study it to determine the effect on 6 minute walking test (MWT) distance after 24 weeks treatment with subcutaneous (SC) Treprostinil Sodium in patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension.
A Genetic Study investigating Vitamin K Epoxide Reductase Complex Subunit 1 in patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension
Inoperable Chronic Thromboembolic Pulmonary Hypertension
Drug: Treprostinil natrium
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
|Official Title:||Double Blind Controlled Clinical Investigation Into the Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Inoperable) Chronic Thromboembolic Pulmonary Hypertension|
- To determine the effect on 6 minute walking test (6MWT) distance after 24 weeks following subcutaneous (sc) Treprostinil Sodium or Control in patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension
- To assess the time to clinical worsening of CTEPH, defined as hospitalization with requirement for additional pulmonary hypertension treatment for worsening CTEPH, loss in functional NYHA class and/or death/transplantation due to worsening CTEPH.
- To assess the effect on maximal Borg score during 6 minute walking test (6MWT)
- To assess the effect on WHO functional class
- To assess the effect on QOL by the MINNESOTA questionnaire
- To assess the effect on brain natriuretic peptide (BNP) and N-terminal pro-BNP levels
- To assess the effect on asymmetric dimethylarginine (ADMA) levels
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||September 2012|
|Active Comparator: Treprostinil, prostaglandine, subcutaneous infusion||Drug: Treprostinil natrium|
Chronic thromboembolic pulmonary hypertension (CTEPH) is characterized by non-resolving organized thromboembolic obstructing the pulmonary vascular bed (Lang, 1994). These thrombi are resistant to thrombolytic therapy and chronic plasmatic anticoagulation. An increase in pulmonary vascular resistance (PVR), right ventricular overload, and eventually right ventricular failure ensue.
The treatment of choice for CTEPH is pulmonary endarterectomy (PEA), providing a potential cure for the disease (Klepetko, 2004)). However, about 50 % of patients are not candidates for surgery, mainly because of distal location of thromboemboli. Despite recent advances in the treatment of pulmonary arterial hypertension (PAH) (McLaughlin, 2004), medical treatments have not been recommended for inoperable CTEPH, because of the concept that a predominantly major vessel obstructive arteriopathy would not be suitable for vasodilators. Furthermore, a major drawback of i.v. prostacyclin therapy is the need for a permanent central venous access that increases the risk of infection (0.22-0.68 per patient per year) (Kuhn, 2003), thrombosis and new major vessel thromboembolism.
|Medical University of Vienna AKH - Division Cardiology|
|II. interní klinika Všeobecná fakultní nemocnice|
|Prague, Czech Republic|
|Medical University Carl Gustav Carus Medizinische Klinik und Poliklinik I Medizinische Fakultät der Technischen Universität Dresden|
|NZOZ Europejskie Centrum Zdrowia Otwock|
|Otwock, Poland, 05-400|