Overview
Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance & 6-minute Walk Distance in Patients With Pulmonary Arterial Hypertension
Status:
Withdrawn
Withdrawn
Trial end date:
2017-02-01
2017-02-01
Target enrollment:
0
0
Participant gender:
All
All
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.Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
ActelionTreatments:
Endothelin Receptor Antagonists
Criteria
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