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

NCT ID: NCT02309463

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-02-28

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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Endothelin receptor antagonist therapy

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

AC-055-506

Identifier Type: -

Identifier Source: org_study_id