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Clinical Trials in France / NCT06445673
Enrolling by invitation Observational

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 France 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
No
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)

FacilityCityRegionStatus
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 France

Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients Recruiting
A Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Essential Thrombocythaemia Patients Active, not recruiting
Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH Recruiting

Other trials for the same condition

Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients Recruiting
Evolution of Hypoxic Burden and Sympathetic/Parasympathetic Balance in Patients With Pulmonary Hypertension Starting soon
A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension Active, not recruiting
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION) Active, not recruiting
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Enrolling by invitation
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 France