Hemodynamic Response After Six Months of Sildenafil

Hemodynamic Evaluation of Patients With Pulmonary Arterial Hypertension. Response to Sildenafil Treatment

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00483626

Enrollment

Registered

2007-06-07

Start date

2003-08-31

Completion date

2007-06-30

Last updated

2007-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Keywords

hemodynamic, pulmonary hypertension, sildenafil

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.

Interventions

DRUGoral sildenafil

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Arterial pulmonary resistance index	6 months

Secondary

Measure	Time frame
Mean pulmonary arterial pressure, Cardiac index, pulmonary saturation, walked distance, functional class.	6 months

Countries

Chile

Contacts

Primary ContactMonica M Zagolin, MD

monizagolin@hotmail.com056-2-3403505

Backup ContactPolentzi Uriarte, MD

puriarte@alemana.cl056-2-3403505

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026