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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

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring hemodynamic, pulmonary hypertension, sildenafil

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT00483626

First Posted

June 6, 2007

Last Updated

June 6, 2007

Sponsor

University of Chile

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

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

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

monizagolin@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Polentzi Uriarte, MD

Phone

056-2-3403505

Ext

504

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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