Efficacy and safety of sildenafil in the treatment of pulmonary arterial hypertension (PAH) after cardiac surgery in Japanese pediatric population - a PAH management
- Conditions
- pulmonary hypertension
- Registration Number
- JPRN-UMIN000012669
- Lead Sponsor
- Osaka Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
Patients with opened chest Patients with ventricular assist device Patients with extracorporeal membrane oxygenation Patients who are judged as inappropriate to include in this study. Patients with chronic lung disease, retinopathy, or gastrointestinal problems Patients who are received Nitrates or nitric oxide donors in non-intravenous form (oral, sublingual, buccal, transdermal, inhalation or aerosol) within 48 hours prior to receiving study drug treatment or intravenous forms within 2 hours prior to receiving study drug treatment (sildenafil is known to potentiate the hypotensive effects of nitrates; its concurrent use is contraindicated) Patients who are received endothelin antagonists(eg, bosentan) Patients who are received potent cytochrome P450 3A4 inhibitors (eg, erythromycin, ketoconazole, itraconazole, and protease inhibitors) (Use of aprotinin will be allowed; aprotinin does not inhibit cytochrome P450 enzymes) Patients who are received ritonavir or nicorandil.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in mean pulmonary arterial pressure after 4 hour administration from baseline
- Secondary Outcome Measures
Name Time Method PAH crisis disappears Additional medication for PAH Successful wean from inhaled nitric oxide or other vasodilators Rebound PAH Duration of mechanical ventilation ICU stay