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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Drug: Endothelin receptor antagonist therapy

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
WHO Functional Class		Baseline to Week 54
NT-ProBNP/BNP		Baseline to Week 54
Echocardiography parameters	Tricuspid pressure gradient; TAPSE; Pulmonary outflow tract acceleration time; Right ventricular fractional area change; Pericardial effusion	Baseline to Week 54
Number of hospitalization due to PAH (min. overnight)		Baseline to Week 54
Quality of Life	Minnesota Living with Heart Failure Questionnaire (MLHFQ)	Baseline to Week 54

Collaborators and Investigators

• Sponsor: Actelion

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2015
• Primary Completion (Estimated): January 31, 2016
• Study Completion (Estimated): February 28, 2017

Study Registration Dates

• First Submitted: October 22, 2014
• First Submitted That Met QC Criteria: December 4, 2014
• First Posted (Estimated): December 5, 2014

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 20, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension; Familial Primary Pulmonary Hypertension; Molecular Mechanisms of Pharmacological Action; Endothelin Receptor Antagonists
• Other Study ID Numbers: AC-055-506