Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost
Recruitment status was Not yet recruiting
Patients with pulmonary arterial hypertension (PAH) suffer from breathlessness, poor quality of life and inability to function, despite medical therapy Current consensus states that combination therapy with different classes of PAH-specific therapy is likely to bring additional benefit to PAH patients. In this study we plan to study how exercise performance changes when the phosphodiesterase inhibitor vardenafil is added to patients who remain symptomatic from PAH when treated with inhaled iloprost.
Following baseline assessment, all Patients will start vardenafil 10 mg bid. If the drug is tolerated by the patients, after a two week period, up titration to 20 mg bid will be permitted, at the discretion of the investigators.
According to treatment protocol up titration will be done carefully and whenever side effects will be reported up titration will be stopped or dosage will be decreased or stopped according to the investigator judgment.
Systemic BP will be measured at baseline assessment. The patient will attend the clinic for the first dose monitoring (10 mg) and after up titration of the study drug to 20 mg.
Systemic BP will be measured at baseline assessment. The patient will attend the clinic for the first dose monitoring (10 mg) and after up titration of the study drug to 20 mg. A fall in SBP of>30 mmHg will be considered significant or any smaller value at the discretion of the investigator. BP will be measured according to the following protocol.
Pre-dose Immediately before administration of vardenafil. This will be timed approximately one hour prior to the next planned dose of iloprost.
Pre-inhalation One hour post vardenafil dose, immediately prior to iloprost inhalation.
Post-inhalation Immediately following completion of iloprost inhalation and every fifteen minutes for one hour.
Prior to discharge Two hours following the iloprost.
Later monitoring At all follow-up visits, BP will be measured.
This is an open-label study to evaluate the safety and efficacy of adding higher doses of vardenafil to inhaled iloprost over 3 months.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Change in 6 minute walk or New York Heart Association functional class. [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Changes in Pulmonary artery pressure assessed (by echo), exercise test parameters, pro-NT BNP, quality of life. Clinical worsening during study, study drop-out and adverse events during the study. [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
There is 2 dosage:10mg Twice daily and 20mg Twice daily
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649739
|Contact: Mordechai R Kramer, MDfirstname.lastname@example.org|
|Contact: Dror Rosengarten, MDemail@example.com|
|Pulmonary Institute,Rabin Medical Center||Not yet recruiting|
|Petach Tikva, Israel, 49100|
|Contact: Mordechai R Kramer, MD 972-39377221 firstname.lastname@example.org|
|Principal Investigator: Mordechai R Kramer, MD|