Hemodynamic Response After Six Months of Sildenafil
Primary Purpose
Pulmonary Arterial Hypertension
Status
Unknown status
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
oral sildenafil
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring hemodynamic, pulmonary hypertension, sildenafil
Eligibility 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.
Sites / Locations
- National Instiute of ThoraxRecruiting
Outcomes
Primary Outcome Measures
Arterial pulmonary resistance index
Secondary Outcome Measures
Mean pulmonary arterial pressure, Cardiac index, pulmonary saturation, walked distance, functional class.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00483626
Brief Title
Hemodynamic Response After Six Months of Sildenafil
Official Title
Hemodynamic Evaluation of Patients With Pulmonary Arterial Hypertension. Response to Sildenafil Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Chile
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
hemodynamic, pulmonary hypertension, sildenafil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
oral sildenafil
Primary Outcome Measure Information:
Title
Arterial pulmonary resistance index
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mean pulmonary arterial pressure, Cardiac index, pulmonary saturation, walked distance, functional class.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica M Zagolin, MD
Phone
056-2-3403505
Ext
504
Email
monizagolin@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Polentzi Uriarte, MD
Phone
056-2-3403505
Ext
504
Email
puriarte@alemana.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica M Zagolin, MD
Organizational Affiliation
National Institute of Thorax
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Instiute of Thorax
City
Santiago
State/Province
Metropolitanta
ZIP/Postal Code
7500691
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Polentzi Uriarte, MD
First Name & Middle Initial & Last Name & Degree
Monica M Zagolin, MD
First Name & Middle Initial & Last Name & Degree
Eduardo Wainsteiin, MD
First Name & Middle Initial & Last Name & Degree
Claudio Parra, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
16291984
Citation
Galie 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. doi: 10.1056/NEJMoa050010. Erratum In: N Engl J Med. 2006 Jun 1;354(22):2400-1.
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Hemodynamic Response After Six Months of Sildenafil
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