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

Pulmonary Arterial Hypertension Clinical Trial

— LONGACT  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02309463
• Other study ID #: AC-055-506
• Status: Withdrawn
• Phase: N/A
• First received: October 22, 2014
• Last updated: March 17, 2016
• Start date: January 2015
• Est. completion date: February 2017

Study information

• Verified date: March 2016
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Endothelin receptor antagonist therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity score measured with an electronic activity tracker and absolute 6MWD assessed at different time points during ERA treatment		Baseline to Week 54	No
Primary	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	No
Secondary	WHO Functional Class		Baseline to Week 54	No
Secondary	NT-ProBNP/BNP		Baseline to Week 54	No
Secondary	Echocardiography parameters	Tricuspid pressure gradient; TAPSE; Pulmonary outflow tract acceleration time; Right ventricular fractional area change; Pericardial effusion	Baseline to Week 54	Yes
Secondary	Number of hospitalization due to PAH (min. overnight)		Baseline to Week 54	Yes
Secondary	Quality of Life	Minnesota Living with Heart Failure Questionnaire (MLHFQ)	Baseline to Week 54	No