Pulmonary Arterial Hypertension Clinical Trial
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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