Hemodynamic Response After Six Months of Sildenafil
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Hemodynamic Evaluation of Patients With Pulmonary Arterial Hypertension. Response to Sildenafil Treatment|
- Arterial pulmonary resistance index [ Time Frame: 6 months ]
- Mean pulmonary arterial pressure, Cardiac index, pulmonary saturation, walked distance, functional class. [ Time Frame: 6 months ]
|Study Start Date:||August 2003|
|Estimated Study Completion Date:||June 2007|
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.
|Contact: Monica M Zagolin, MD||056-2-3403505 ext firstname.lastname@example.org|
|Contact: Polentzi Uriarte, MD||056-2-3403505 ext email@example.com|
|National Instiute of Thorax||Recruiting|
|Santiago, Metropolitanta, Chile, 7500691|
|Sub-Investigator: Polentzi Uriarte, MD|
|Principal Investigator: Monica M Zagolin, MD|
|Sub-Investigator: Eduardo Wainsteiin, MD|
|Sub-Investigator: Claudio Parra, MD|
|Principal Investigator:||Monica M Zagolin, MD||National Institute of Thorax|