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EC did not accept measurement of patient's activity for the primary end-point with a non-validated activity tracking device
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The objective of the study is to monitor physical activity longitudinally with a wrist activity tracker specifically in PAH patients newly initiating ERA therapy and to assess the correlation with the 6MWD at different time points. Further objectives are to assess the correlation of physical activity measured with the tracker and other parameters for clinical evaluation and right ventricular function assessment (i.e. Biomarkers, WHO Functional class, hospitalization due to PAH, Echochardiography and Quality of Life) as well as sleep efficacy in PAH patients newly initiating ERA therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endothelin receptor antagonist therapy | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Activity score measured with an electronic activity tracker and absolute 6MWD assessed at different time points during ERA treatment | Baseline to Week 54 | |
| Change of physical activity measured with an electronic activity tracker and 6MWD in PAH patients newly initiating ERA therapy between visit 0 and end of observation | baseline to week 54 |
| Measure | Description | Time Frame |
|---|---|---|
| WHO Functional Class | Baseline to Week 54 | |
| NT-ProBNP/BNP | Baseline to Week 54 | |
| Echocardiography parameters |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with PAH, and not receiving ERA therapy in the 30 days prior to the enrolment visit, are eligible for inclusion in this study. Patients in need of ERA therapy will receive ERA treatment according to the physician's decision
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|
| Baseline to Week 54 |
| Number of hospitalization due to PAH (min. overnight) | Baseline to Week 54 |
| Quality of Life | Minnesota Living with Heart Failure Questionnaire (MLHFQ) | Baseline to Week 54 |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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