Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)

Study Overview
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Brief Summary
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The objectives of this study are to develop research methods and corresponding materials for a study of the effectiveness of sitaxentan sodium (Thelin) in real-world settings; to pilot test these methods at three study centers in Europe; and to refine and finalize research methods and corresponding materials for possible use in a follow-on, full-scale examination of the effectiveness of sitaxentan sodium (Thelin) in real-world settings.

Detailed Description
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At each centre, approximately 12-15 Pulmonary Arterial Hypertension (PAH) consecutive patients who have received Thelin and who meet all other study entry criteria.

Official Title
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NON-INTERVENTIONAL (NI) DRUG STUDY PROTOCOL: THREE-COUNTRY PILOT STUDY FOR RETROSPECTIVE CHART REVIEW OF EFFECTIVENESS OF THELIN® (SITAXSENTAN) IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Drug: Sitaxentan sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic PAH, or PAH secondary to connective tissue disease Receipt of Thelin for treatment of PAH 6 months of follow-up (except in the event of death) subsequent to initial receipt of Thelin Minimum of one clinic visit documented in the medical record during the 6-month period subsequent to initial receipt of Thelin Exclusion Criteria: Participation in any investigational study of Thelin or any other medication for the treatment of PAH during the period beginning 6 months prior to initial receipt of Thelin and ending 6 months subsequent to such receipt Receipt of Thelin prior to January 11, 2005 (i.e., the date following the last day on which patients could be enrolled in double-blind treatment in STRIDE-1, STRIDE-2, and/or STRIDE-6); or Known contraindications to Thelin therapy (i.e., known hypersensitivity to sitaxsentan or any of its excipients; mild-to-severe hepatic impairment [Child-Pugh Class A-C]; elevated aminotransferases prior to initiation of treatment, defined as aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] >3 times upper limit of normal [ULN]; concomitant use of cyclosporin A; lactation)

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 |
| --- | --- |
| PAH patients receiving Sitaxentan<br> | Drug: Sitaxentan sodium<br>* Sitaxentan sodium 100 mg / day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation | Participants still receiving Thelin with evidence of receipt of another PAH-related therapy (eg. bosentan, sildenafil) not previously received during the study period. Mean time in months to therapy augmentation. | Day 1 to Month 6 | 
| Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching | Participants with evidence of discontinuation of Thelin therapy and evidence of receipt of another PAH-related therapy not previously received during the study period. | Day 1 to Month 6 | 
| Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation | Participants were designated as having discontinued Thelin therapy if there was evidence in the medical records that treatment had been terminated. | Day 1 to Month 6 | 
| Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration | Duration of Thelin therapy based on time from index date (Day 1 of treatment) until the date of discontinuation of Thelin therapy. | Day 1 to Month 6 | 
| Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed | Duration of Thelin therapy from initial receipt until date of discontinuation of thelin therapy or the end of follow-up, whichever occurred first. | Day 1 to Month 6 | 
| Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage | Daily dosage of Thelin based on information in the medical record for the baseline visit and all follow-up clinic visits. | Day 1 to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications | Use of PAH-related medications other than Thelin described by class of agent received. | Day 1 to Month 6 | 
| Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension | Class I: no limitation of usual (usl) physical activity (PA); PA does not increase(d) (incr) dyspnea (dys), fatigue (ftg), chest pain (CP), or syncope (syn); Class II: mild limitation of usl PA; no discomfort at rest, but normal PA causes incr dys, ftg, CP, or presyncope (presyn); Class III: marked limitation of PA; no discomfort at rest but < ordinary activity causes incr dys, ftg, CP, or presyn; Class IV: unable to perform any PA at rest; may have signs of right ventricular failure; sys and/or ftg at rest and symptoms are incr by almost any PA. | Baseline to Month 6 | 
| Change From Baseline in Mean Right Atrial Pressure | Difference between pre-index and follow-up value. | Baseline to Month 6 | 
| Change From Baseline in Mean Pulmonary Artery Pressure | Difference between pre-index and follow-up value. | Baseline to Month 6 | 
| Change From Baseline in Pulmonary Capillary Wedge Pressure | Difference between pre-index and follow-up value. | Baseline to Month 6 | 
| Change From Baseline in Left Ventricular End Diastolic Pressure | Difference between pre-index and follow-up value. | Baseline to Month 6 | 
| Change From Baseline in Pulmonary Vascular Resistance | Difference between pre-index and follow-up value. | Baseline to Month 6 | 
| Change From Baseline in Cardiac Output | Difference between pre-index and follow-up value. | Baseline to Month 6 | 
| Change From Baseline in Tei Index | Difference between pre-index and follow-up value. Combined myocardial performance index calculated by adding isovolumic contraction time and isovolumic relaxation time and dividing the resulting sum by ejection time. | Baseline to Month 6 | 
| Change From Baseline in Tricuspid Regurgitant Velocity | Difference between pre-index and follow-up value. | Baseline to Month 6 | 
| Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT) | 6MWT 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. Continuous pulse oximetry was conducted during the test for safety. Difference between pre-index and follow-up value. | Baseline to Month 6 | 
| Change From Baseline in Borg Dyspnoea Score | Borg dyspnoea scale is a 10-point scale where following scores stands for severity of dyspnoea: 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 breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum] and 10 (maximum). Difference between pre-index and follow-up value. | Baseline to Month 6 | 
| Change From Baseline in Percent of Predicted Peak VO2 | Difference between pre-index and follow-up value. | Baseline to Month 6 | 
| Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening | Occurrence of any of the following: death, unplanned PAH-related hospitalization, initiation of epoprostenol, arterial septostomy, lung or heart/lung transplantation, ≥15% decrease from baseline in 6 minute walk test, signs/symptoms of right sided heart failure, and/or worsening WHO functional class. | Day 1 to Month 6 | 
| Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality | Number of participants who died during the follow-up period. | Day 1 to Month 6 | 
| Number of Hospitalizations | All hospitalizations during the follow-up period recorded in medical records. | Day 1 to Month 6 | 
| Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation | Number of participants who received an lung transplant during hospitalization. | Day 1 to Month 6 | 
| Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Heart/Lung Transplantation | Number of participants who received an heart/lung transplant during hospitalization. | Day 1 to Month 6 | 
| Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Atrial Septostomy | Number of participants who received an atrial septostomy (balloon or blade) during hospitalization. | Day 1 to Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary arterial hypertension, sitaxentan sodium, Thelin