Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance & 6-minute Walk Distance in Patients With Pulmonary Arterial Hypertension (LONGACT)

Actelion Pharmaceuticals

Status: Withdrawn

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Endothelin receptor antagonist therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT02309463

AC-055-506

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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