Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension

Study Overview
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Brief Summary
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The objective of this observational study is to gain clinical insight on the actual use of sildenafil citrate (Revatio™) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of sildenafil at doses ≥20mg three times daily for the treatment of PAH.

Detailed Description
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The study design proposed is a retrospective chart review going back five years (01 April 2006 estimate) from the time of study initiation (31 March 2011 estimate). Within this five-year period, study index will occur the first time an adult patient begins sildenafil for the treatment of PAH for a period of at least three months. The patient has to be taking sildenafil at doses ≥ 20mg tid for the treatment of PAH.

Official Title
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Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Drug: sildenafil citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be at least 18 years of age at study index; Patients must have a diagnosis of PAH. PAH is conventionally defined as a mean pulmonary arterial pressure (PAP) of > 25 mmHg and a pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg and a pulmonary vascular resistance (PVR) ≥ 240 dynes/s/cm-5 at right heart catheterization; Patients must have initiated sildenafil for the treatment of their PAH; at dose ≥ 20 mg tid within 5 years prior to study initiation Exclusion Criteria: Patient has known contraindications to sildenafil at study index; Patient participated in an investigational study of sildenafil treatment for PAH during the period beginning 6 months prior to study index

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sildenafil ≥20mg three times daily<br>Subjects receiving sildenafil ≥20mg three times daily for the treatment of PAH | Drug: sildenafil citrate<br>* Sildenafil citrate, 20mg oral tablets, taken at least three times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1 | 6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Baseline, Year 1 | 
| Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 2 | 6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Baseline, Year 2 | 
| Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 3 | 6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Baseline, Year 3 | 
| Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 4 | 6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Baseline, Year 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in New York Heart Association, World Health Organization (NYHA/WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Year 1, 2, 3 and 4 | NYHA/WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class, deterioration = increase in functional class, no change = no change in functional class. Number of participants in each functional class was reported. | Baseline, Year 1, 2, 3, 4 | 
| Change From Baseline in Right Atrial Pressure (RAP) at Year 1, 2, 3 and 4 | RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. | Baseline, Year 1, 2, 3, 4 | 
| Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Rest at Year 1, 2, 3 and 4 | mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. | Baseline, Year 1, 2, 3, 4 | 
| Change From Baseline in Pulmonary Vascular Resistance (PVR) at Year 1, 2, 3 and 4 | PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm). | Baseline, Year 1, 2, 3, 4 | 
| Change From Baseline in Cardiac Index (CI) at Year 1, 2, 3 and 4 | CI: calculated as COsys divided by BSA. | Baseline, Year 1, 2, 3, 4 | 
| Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Year 1, 2, 3 and 4 | PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure. | Baseline, Year 1, 2, 3, 4 | 
| Change From Baseline in Borg Dyspnea Index at Year 1, 2, 3 and 4 | Borg dyspnea scale: 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all;0.5=very very slight (just noticeable); 1=very slight; 2=slight breathlessness; 3=moderate; 4=some what severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum. | Baseline, Year 1, 2, 3, 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary arterial hypertension, sildenafil citrate, Revatio