Hemodynamic Response After Six Months of Sildenafil
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|ClinicalTrials.gov Identifier: NCT00483626|
Recruitment Status : Unknown
Verified April 2007 by University of Chile.
Recruitment status was: Recruiting
First Posted : June 7, 2007
Last Update Posted : June 7, 2007
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: oral sildenafil||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hemodynamic Evaluation of Patients With Pulmonary Arterial Hypertension. Response to Sildenafil Treatment|
|Study Start Date :||August 2003|
|Estimated Study Completion Date :||June 2007|
U.S. FDA Resources
- Arterial pulmonary resistance index [ Time Frame: 6 months ]
- Mean pulmonary arterial pressure, Cardiac index, pulmonary saturation, walked distance, functional class. [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483626
|Contact: Monica M Zagolin, MD||056-2-3403505 ext email@example.com|
|Contact: Polentzi Uriarte, MD||056-2-3403505 ext firstname.lastname@example.org|
|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|