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Hemodynamic Response After Six Months of Sildenafil

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University of Chile.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Chile
ClinicalTrials.gov Identifier:
NCT00483626
First received: June 6, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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 Intervention Phase
Pulmonary Arterial Hypertension
 Drug: oral sildenafil
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chile:

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

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

Estimated Enrollment: 27
Study Start Date: August 2003
Estimated Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483626

Contacts
Contact: Monica M Zagolin, MD 056-2-3403505 ext 504 monizagolin@hotmail.com
Contact: Polentzi Uriarte, MD 056-2-3403505 ext 504 puriarte@alemana.cl

Locations
Chile
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
Investigators
Principal Investigator: Monica M Zagolin, MD National Institute of Thorax
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00483626     History of Changes
Other Study ID Numbers: Thorax-001-2003
Study First Received: June 6, 2007
Last Updated: June 6, 2007
Health Authority: Chile: Instituto de Salud Publica de Chile

Keywords provided by University of Chile:
hemodynamic
pulmonary hypertension
sildenafil

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Sildenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013