NCT00483626

Hemodynamic Response After Six Months of Sildenafil

Hemodynamic Evaluation of Patients With Pulmonary Arterial Hypertension. Response to Sildenafil Treatment

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: University of Chile · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the clinical, functional and hemodynamic response after six months of sildenafil 50 mg TID in patients with pulmonary arterial hypertension.

Detailed description

Pulmonary arterial hypertension is a chronic devastating disease. There are few approval oral treatments. Sildenafil, a phosphodiesterase 5 inhibitors, has been recently approved for patients on functional class II and III showing hemodynamic benefits after 12 weeks of treatment. Long term hemodynamic evaluation after sildenafil treatment has not been evaluating in pulmonary arterial patients on functional class II to IV. The protocol has been designed to evaluate patients on functional class II to IV from baseline conditions and after 6 months of sildenafil treatment (50 mg po TID). Clinical (functional class), functional (walked distance-6 minute walking test) and Hemodynamic evaluation is planned to be performed at baseline and after 6 months of treatment.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	oral sildenafil

Timeline

• Start date: 2003-08-01
• Completion: 2007-06-01
• First posted: 2007-06-07
• Last updated: 2007-06-07

Locations

1 site across 1 country: Chile