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

NCT06445673 · tracked via the Priya Life Science Germany tracker

Sponsor

AOP Orphan Pharmaceuticals AG

Phase

Observational

Started

2024-07-31

Last updated

2024-08-07

Condition(s) studied

Pulmonary Arterial Hypertension

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1\. Patients previously participating in the randomized TripleTRE trial who are able and willing to provide a signed informed consent for study participation in NIS Exclusion Criteria: 1. Lost to follow-up patients of TripleTRE study 2. Patients who discontinued all medicinal PAH treatments (e.g. after successful lung transplantation) 3. Patients who withdrew from the initial TripleTRE trial due to significant non-compliance with trial requirements (not adhering to therapy, not coming to hospital visits)

Primary outcome measure(s)

Time to death or lung transplantation — up to year 3
Time to first clinical worsening — up to year 3
clinical worsening is defined as fulfilling on of the following criteria: * PAH related death (including all deaths where PAH cannot be excluded as cause) * Lung transplantation due to PAH * PAH-related hospitalization * Post baseline decrease in 6MWD by 15% * Post baseline worsening of WHO FC
Total number of clinical worsenings — up to year 3
clinical worsening is defined as fulfilling on of the following criteria: * PAH related death (including all deaths where PAH cannot be excluded as cause) * Lung transplantation due to PAH * PH-related hospitalization * Post baseline decrease in 6MWD by 15% * Post baseline worsening of WHO FC

Trial sites (18)

Facility	City	Region
Ordensklinikum Linz	Linz	Austria
Medical University Vienna	Vienna	Austria
Fakultní Nemocnice Olomouc	Olomouc	Czechia
Všeobecná fakultní nemocnice v Praze	Prague	Czechia
Hôpital Bicêtre-- Assistance Publique Hopitaux de Paris	Paris	France
Hôpitaux Universitaires de Strasbourg	Strasbourg	France
DRK Kliniken Berlin Westend	Berlin	Germany
University Hospital Carl Gustav Carus of Technical University Dresden	Dresden	Germany
Universitätsmedizin Greifswald	Greifswald	Germany
Gottsegen National Cardiovascular lnstitute	Budapest	Hungary
Medical University of Szeged	Szeged	Hungary
Sapienza University of Rome	Rome	Italy
John Paul II Hospital Krakow	Krakow	Poland
Fryderyk Chopin Hospital in European Health Centre Otwock	Otwock	Poland
Emergency Institute for Cardiovascular Diseases Prof. Dr. C.C.Iliescu	Bucharest	Romania
Emergency Clinical County Hospital of Targu Mures	Târgu Mureş	Romania
Hospital Clinic of Barcelona	Barcelona	Spain
Hospital Ramon y Cajal	Madrid	Spain

More AOP Orphan Pharmaceuticals AG trials in Germany

A Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Essential Thrombocythaemia Patients Active, not recruiting

Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients Recruiting

Other trials for the same condition

Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH) Active, not recruiting

An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH) Recruiting

A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Enrolling by invitation

Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT) Recruiting

Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06445673 on ClinicalTrials.gov ↗ ← All trials in Germany