A Prospective Non-interventional Observational Study to Observe Long-term Treatment and Outcomes in Pulmonary Arterial Hypertension (PAH) Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pulmonary Arterial Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Czechia, France, Germany, Hungary +4
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Primary outcome measures
- Time to death or lung transplantation [Time frame: up to year 3]
- Time to first clinical worsening [Time frame: up to year 3]
- Total number of clinical worsenings [Time frame: up to year 3]
Secondary outcome measures (12)
- Long-term change in 6MWD [Time frame: up to year 3]
- Long-term change in PAH treatment regimens [Time frame: up to year 3]
- Long-term change in risk status [Time frame: up to year 3]
- Long-term change in WHO FC [Time frame: up to year 3]
- Long-term change in BDS [Time frame: up to year 3]
- Long-term change in NT-proBNP/BNP [Time frame: up to year 3]
- Long-term change in Pulmonary Vascular Resistance (PVR) [Time frame: up to year 3]
- Long-term change in mean Pulmonary Arterial Pressure (mPAP) [Time frame: up to year 3]
- Long-term change in Right Atrial Pressure (RAP) [Time frame: up to year 3]
- Long-term change in mean Right Atrial Pressure (mRAP) [Time frame: up to year 3]
- Long-term change in Cardiac Index (CI) [Time frame: up to year 3]
- Long-term change in Cardiac Output (CO) [Time frame: up to year 3]
Eligibility criteria
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
- Lost to follow-up patients of TripleTRE study
- Patients who discontinued all medicinal PAH treatments (e.g. after successful lung transplantation)
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 3 centers
- DRK Kliniken Berlin Westend — Berlin
- University Hospital Carl Gustav Carus of Technical University Dresden — Dresden
- Universitätsmedizin Greifswald — Greifswald
Austria · 2 centers
- Ordensklinikum Linz — Linz
- Medical University Vienna — Vienna
Czechia · 2 centers
- Fakultní Nemocnice Olomouc — Olomouc
- Všeobecná fakultní nemocnice v Praze — Prague
France · 2 centers
- Hôpital Bicêtre-- Assistance Publique Hopitaux de Paris — Paris
- Hôpitaux Universitaires de Strasbourg — Strasbourg
Hungary · 2 centers
- Gottsegen National Cardiovascular lnstitute — Budapest
- Medical University of Szeged — Szeged
Poland · 2 centers
- John Paul II Hospital Krakow — Krakow
- Fryderyk Chopin Hospital in European Health Centre Otwock — Otwock
Romania · 2 centers
- Emergency Institute for Cardiovascular Diseases Prof. Dr. C.C.Iliescu — Bucharest
- Emergency Clinical County Hospital of Targu Mures — Târgu Mureş
Spain · 2 centers
- Hospital Clinic of Barcelona — Barcelona
- Hospital Ramon y Cajal — Madrid
Italy · 1 center
- Sapienza University of Rome — Rome
Identifiers
NCT: NCT06445673 · TREV1-10P.NIS