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

NCT02309463 | Withdrawn

• 1 other identifier: AC-055-506
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• WHO Functional Class

  Baseline to Week 54

• NT-ProBNP/BNP

  Baseline to Week 54

• Echocardiography parameters

  Baseline to Week 54

• Number of hospitalization due to PAH (min. overnight)

  Baseline to Week 54

• Quality of Life

  Baseline to Week 54

Interventions

Endothelin receptor antagonist therapy DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with PAH, and not receiving ERA therapy in the 30 days prior to the enrolment visit, are eligible for inclusion in this study. Patients in need of ERA therapy will receive ERA treatment according to the physician's decision

You may qualify if:

• 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

You may not qualify if:

• Patient with conditions that prevent compliance with the protocol or to adhere to therapy and use of the device

Sponsors & Collaborators

• Actelion: lead

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: December 5, 2014
• Study Start: January 31, 2015
• Primary Completion: January 31, 2016
• Study Completion: February 28, 2017
• Last Updated: June 22, 2025

Record last verified: 2025-06