Hemodynamic Response After Six Months of Sildenafil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
University of Chile

Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: oral sildenafil Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Primary Outcome Measures :
  1. Arterial pulmonary resistance index [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Mean pulmonary arterial pressure, Cardiac index, pulmonary saturation, walked distance, functional class. [ Time Frame: 6 months ]

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00483626

Contact: Monica M Zagolin, MD 056-2-3403505 ext 504
Contact: Polentzi Uriarte, MD 056-2-3403505 ext 504

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         
Sponsors and Collaborators
University of Chile
Principal Investigator: Monica M Zagolin, MD National Institute of Thorax

Publications: Identifier: NCT00483626     History of Changes
Other Study ID Numbers: Thorax-001-2003
First Posted: June 7, 2007    Key Record Dates
Last Update Posted: June 7, 2007
Last Verified: April 2007

Keywords provided by University of Chile:
pulmonary hypertension

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents