Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)
- Registration Number
- NCT01445873
- Lead Sponsor
- Pfizer
- Brief Summary
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
At each centre, approximately 12-15 Pulmonary Arterial Hypertension (PAH) consecutive patients who have received Thelin and who meet all other study entry criteria.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PAH patients receiving Sitaxentan Sitaxentan sodium -
- Primary Outcome Measures
Name Time Method Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed Day 1 to Month 6 Duration of Thelin therapy from initial receipt until date of discontinuation of thelin therapy or the end of follow-up, whichever occurred first.
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation Day 1 to Month 6 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.
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching Day 1 to Month 6 Participants with evidence of discontinuation of Thelin therapy and evidence of receipt of another PAH-related therapy not previously received during the study period.
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage Day 1 to Month 6 Daily dosage of Thelin based on information in the medical record for the baseline visit and all follow-up clinic visits.
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation Day 1 to Month 6 Participants were designated as having discontinued Thelin therapy if there was evidence in the medical records that treatment had been terminated.
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration Day 1 to Month 6 Duration of Thelin therapy based on time from index date (Day 1 of treatment) until the date of discontinuation of Thelin therapy.
- Secondary Outcome Measures
Name Time Method Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications Day 1 to Month 6 Use of PAH-related medications other than Thelin described by class of agent received.
Change From Baseline in Mean Right Atrial Pressure Baseline to Month 6 Difference between pre-index and follow-up value.
Change From Baseline in Borg Dyspnoea Score Baseline to Month 6 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.
Change From Baseline in Percent of Predicted Peak VO2 Baseline to Month 6 Difference between pre-index and follow-up value.
Number of Hospitalizations Day 1 to Month 6 All hospitalizations during the follow-up period recorded in medical records.
Change From Baseline in Mean Pulmonary Artery Pressure Baseline to Month 6 Difference between pre-index and follow-up value.
Change From Baseline in Pulmonary Vascular Resistance Baseline to Month 6 Difference between pre-index and follow-up value.
Change From Baseline in Tricuspid Regurgitant Velocity Baseline to Month 6 Difference between pre-index and follow-up value.
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Atrial Septostomy Day 1 to Month 6 Number of participants who received an atrial septostomy (balloon or blade) during hospitalization.
Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension Baseline to Month 6 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.
Change From Baseline in Pulmonary Capillary Wedge Pressure Baseline to Month 6 Difference between pre-index and follow-up value.
Change From Baseline in Tei Index Baseline to Month 6 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.
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality Day 1 to Month 6 Number of participants who died during the follow-up period.
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation Day 1 to Month 6 Number of participants who received an lung transplant during hospitalization.
Change From Baseline in Left Ventricular End Diastolic Pressure Baseline to Month 6 Difference between pre-index and follow-up value.
Change From Baseline in Cardiac Output Baseline to Month 6 Difference between pre-index and follow-up value.
Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT) Baseline to Month 6 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.
Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening Day 1 to Month 6 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.
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Heart/Lung Transplantation Day 1 to Month 6 Number of participants who received an heart/lung transplant during hospitalization.