NCT04955990

A Study of Real-world Cohort of Pulmonary Arterial Hypertension (PAH) Participants

An International, Non-Drug Interventional, Real-world Cohort of PAH Patients Newly Initiating PAH Therapy With Guideline-directed Assessments of Disease Severity

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to describe pulmonary arterial hypertension (PAH) participants in terms of their clinical characteristics, therapies used, disease progression, and outcomes (example, death, hospitalization, risk category for predicted mortality risk, and patient-reported outcomes \[PROs\]) in real-world clinical practice. This study will collect high-quality real-world data that may be used as a stand-alone dataset or in combination with other studies to address relevant research questions (example, serve as an external control dataset to another study) to support development and access to PAH therapies, as well as to contribute to the knowledge base of PAH through publications.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
OTHER	PAH Therapies	No Drug will be administered as part of this study. Real world data will be collected in participants who newly initiate PAH therapies in routine clinical setting or have already been receiving macitentan 10 mg for at least 3 months prior to the index date.

Timeline

• Start date: 2021-10-14
• Primary completion: 2022-12-20
• Completion: 2022-12-20
• First posted: 2021-07-09
• Last updated: 2025-02-03

Locations

54 sites across 17 countries: United States, Argentina, Brazil, Canada, China, Germany, Italy, Japan, Malaysia, Netherlands, Poland, Puerto Rico, Singapore, South Korea, Spain, Sweden, United Kingdom