Ignite Creation Date:
2024-05-06 @ 3:28 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02309463
Status:
WITHDRAWN
Last Update Posted:
2016-03-18
First Post:
2014-10-22
Brief Title:
Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance 6-minute Walk Distance in Patients With Pulmonary Arterial Hypertension
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Prospective Multicenter Study to Assess the Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance and 6-minute Walk Distance in Patients With Pulmonary Arterial Hypertension Newly Initiating Endothelin Receptor Antagonist Therapy
Status:
WITHDRAWN
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
EC did not accept measurement of patients activity for the primary end-point with a non-validated activity tracking device
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LONGACT
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 ie 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None