NCT06445673

A Prospective Non-interventional Observational Study to Observe Long-term Treatment and Outcomes in Pulmonary Arterial Hypertension (PAH) Patients

A Prospective, Multicenter, International Non-interventional, Observational Cohort Study to Observe Long-term Treatment Patterns and Real-word Outcomes in PAH Group I Patients Previously Participating in TripleTRE - TripleTRE-NIS

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: AOP Orphan Pharmaceuticals AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to learn about the long-term development and outcomes of different treatment patterns of patients who initially participated in the TripleTRE study. The primary objective of this non-interventional follow-up study is to assess the long-term real-world clinical outcomes, including disease progression and survival rates, in patients who initially participated in and completed the randomized TripleTRE trial. Planned observation duration per patient is a minimum of 3 years.

Conditions

• Pulmonary Arterial Hypertension

Timeline

• Start date: 2024-07-31
• Primary completion: 2030-06-01
• Completion: 2030-06-01
• First posted: 2024-06-06
• Last updated: 2024-08-07

Locations

18 sites across 9 countries: Austria, Czechia, France, Germany, Hungary, Italy, Poland, Romania, Spain