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

Официальное название

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

Обзор

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.

Первичные конечные точки

• Time to death or lung transplantation [Срок оценки: up to year 3]
• Time to first clinical worsening [Срок оценки: up to year 3]
• Total number of clinical worsenings [Срок оценки: up to year 3]

Вторичные конечные точки (12)

• Long-term change in 6MWD [Срок оценки: up to year 3]
• Long-term change in PAH treatment regimens [Срок оценки: up to year 3]
• Long-term change in risk status [Срок оценки: up to year 3]
• Long-term change in WHO FC [Срок оценки: up to year 3]
• Long-term change in BDS [Срок оценки: up to year 3]
• Long-term change in NT-proBNP/BNP [Срок оценки: up to year 3]
• Long-term change in Pulmonary Vascular Resistance (PVR) [Срок оценки: up to year 3]
• Long-term change in mean Pulmonary Arterial Pressure (mPAP) [Срок оценки: up to year 3]
• Long-term change in Right Atrial Pressure (RAP) [Срок оценки: up to year 3]
• Long-term change in mean Right Atrial Pressure (mRAP) [Срок оценки: up to year 3]
• Long-term change in Cardiac Index (CI) [Срок оценки: up to year 3]
• Long-term change in Cardiac Output (CO) [Срок оценки: up to year 3]

Критерии участия

Критерии включения

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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 3 центра

• DRK Kliniken Berlin Westend — Berlin
• University Hospital Carl Gustav Carus of Technical University Dresden — Dresden
• Universitätsmedizin Greifswald — Greifswald

Австрия · 2 центра

• Ordensklinikum Linz — Linz
• Medical University Vienna — Vienna

Чехия · 2 центра

• Fakultní Nemocnice Olomouc — Olomouc
• Všeobecná fakultní nemocnice v Praze — Prague

Франция · 2 центра

• Hôpital Bicêtre-- Assistance Publique Hopitaux de Paris — Paris
• Hôpitaux Universitaires de Strasbourg — Strasbourg

Венгрия · 2 центра

• Gottsegen National Cardiovascular lnstitute — Budapest
• Medical University of Szeged — Szeged

Польша · 2 центра

• John Paul II Hospital Krakow — Krakow
• Fryderyk Chopin Hospital in European Health Centre Otwock — Otwock

Румыния · 2 центра

• Emergency Institute for Cardiovascular Diseases Prof. Dr. C.C.Iliescu — Bucharest
• Emergency Clinical County Hospital of Targu Mures — Târgu Mureş

Испания · 2 центра

• Hospital Clinic of Barcelona — Barcelona
• Hospital Ramon y Cajal — Madrid

Италия · 1 центр

• Sapienza University of Rome — Rome

Идентификаторы

NCT: NCT06445673 · TREV1-10P.NIS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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