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Hemodynamic Response After Six Months of Sildenafil

NCT ID: NCT00483626

Last Updated: 2007-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2007-06-30

Brief Summary

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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

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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.

Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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oral sildenafil

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chile

OTHER

Sponsor Role lead

Principal Investigators

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Monica M Zagolin, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Thorax

Locations

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National Instiute of Thorax

Santiago, Metropolitanta, Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Monica M Zagolin, MD

Role: CONTACT

[email protected]
056-2-3403505 ext. 504

Polentzi Uriarte, MD

Role: CONTACT

[email protected]
056-2-3403505 ext. 504

References

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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.

Reference Type BACKGROUND
PMID: 16291984 (View on PubMed)

Other Identifiers

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Thorax-001-2003

Identifier Type: -

Identifier Source: org_study_id