Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.
Recruitment status was Not yet recruiting
Pulmonary arterial hypertension is a chronic disease of the lung blood vessels resulting in constriction and high pressures. Treatment is given with a variety of drugs including the prostanoid class (e.g. epoprostenol, iloprost and the phosphodiesterase 5 (PDE-5) inhibitors (e.g. sildenafil).
Although these drugs are known to be effective alone, little is known about combining them together in various combinations.
In this trial we will add a long-acting PDE-5 inhibitor to the treatment of patients with pulmonary arterial hypertension who currently are receiving only a prostanoid drug.
Pulmonary Arterial Hypertension
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Six minute walking distance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Level of pro-NT BNP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Echo-derived parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Cardiopulmonary exercise test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Patients treated with epoprostenol (Flolan) will be given tadalafil (Cialis).
Orally, titrated to maximum 20mg od
Other Name: Cialis
Patients receiving iloprost (Ventavis) will receive vardenafil (Levitra)
Orally, titrated to 10 mg bid
Other Name: Levitra
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705588
|Contact: Mordechai R Kramer, MDfirstname.lastname@example.org|
|Pulmonary Institute, Rabin Medical Center||Not yet recruiting|
|Petach Tikva, Israel, 49100|
|Sub-Investigator: Benjamin D Fox, BM BCh MRCP|
|Principal Investigator:||Mordechai R Kramer, MD||Rabin Medical Center|