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

Withdrawn

• Conditions: Pulmonary Arterial Hypertension

• Registration Number: NCT02309463
• Lead Sponsor: Actelion

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-05
• Study Start: 2015-01
• Primary Completion: 2016-01
• Study Completion: 2017-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
WHO Functional Class	Baseline to Week 54
Number of hospitalization due to PAH (min. overnight)	Baseline to Week 54
Quality of Life	Baseline to Week 54	Minnesota Living with Heart Failure Questionnaire (MLHFQ)
NT-ProBNP/BNP	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