Hemodynamic Response After Six Months of Sildenafil

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00483626
• Other study ID #: Thorax-001-2003
• Status: Recruiting
• Phase: Phase 4
• First received: June 6, 2007
• Last updated: June 6, 2007
• Start date: August 2003
• Est. completion date: June 2007

Study information

• Verified date: April 2007
• Source: University of Chile
• Contact: Monica M Zagolin, MD
• Phone: 056-2-3403505
• Email: monizagolin[@]hotmail.com
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de Chile
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients older than 15 years old with Pulmonary arterial hypertension according with WHO hemodynamic definition,

• Who signed informed consent,

• Able to swallow tablets and follow instructions.

Exclusion Criteria:

• Patients with pulmonary hypertension with other categories than pulmonary arterial hypertension (associated to COPD, lund diseases, sleep apnea, thromboembolic disease, hight altitude), patients asymptomatic, patients who were responders to adenosine during hemodynamic test, patients treated with specific treatments for pulmonary arterial hypertension before started the study such as sildenafil, prostanoids, endothelin receptors blockers.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• oral sildenafil

Locations

Country	Name	City	State
Chile	National Instiute of Thorax	Santiago	Metropolitanta

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (1)

Galiè N, Ghofrani HA, Torbicki A, Barst RJ, Rubin LJ, Badesch D, Fleming T, Parpia T, Burgess G, Branzi A, Grimminger F, Kurzyna M, Simonneau G; Sildenafil Use in Pulmonary Arterial Hypertension (SUPER) Study Group. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med. 2005 Nov 17;353(20):2148-57. Erratum in: N Engl J Med. 2006 Jun 1;354(22):2400-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial pulmonary resistance index		6 months
Secondary	Mean pulmonary arterial pressure, Cardiac index, pulmonary saturation, walked distance, functional class.		6 months