Pulmonary Arterial Hypertension
Conditions
Brief summary
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.
Interventions
DRUGEndothelin receptor antagonist therapy
Sponsors
Actelion
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients with right heart catheter (RHC)-confirmed PAH (WHO PH group I) * Age ≥18 year * Not receiving ERA therapy in the 30 days prior to the enrolment visit * Signed patient informed consent form
Exclusion criteria
* Patient with conditions that prevent compliance with the protocol or to adhere to therapy and use of the device
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NT-ProBNP/BNP | Baseline to Week 54 | — |
| Quality of Life | Baseline to Week 54 | Minnesota Living with Heart Failure Questionnaire (MLHFQ) |
| Number of hospitalization due to PAH (min. overnight) | Baseline to Week 54 | — |
| Echocardiography parameters | Baseline to Week 54 | * Tricuspid pressure gradient * TAPSE * Pulmonary outflow tract acceleration time * Right ventricular fractional area change * Pericardial effusion |
| WHO Functional Class | Baseline to Week 54 | — |
Outcome results
None listed