Hemodynamic Response After Six Months of Sildenafil
Hemodynamic Evaluation of Patients With Pulmonary Arterial Hypertension. Response to Sildenafil Treatment
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2003
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 6, 2007
CompletedFirst Posted
Study publicly available on registry
June 7, 2007
CompletedJune 7, 2007
April 1, 2007
June 6, 2007
June 6, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Arterial pulmonary resistance index
6 months
Secondary Outcomes (1)
Mean pulmonary arterial pressure, Cardiac index, pulmonary saturation, walked distance, functional class.
6 months
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Instiute of Thorax
Santiago, Metropolitanta, 7500691, Chile
Related Publications (1)
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.
PMID: 16291984BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monica M Zagolin, MD
National Institute of Thorax
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 6, 2007
First Posted
June 7, 2007
Study Start
August 1, 2003
Study Completion
June 1, 2007
Last Updated
June 7, 2007
Record last verified: 2007-04