A Prospective Non-interventional Observational Study to Observe Long-term Treatment and Outcomes in Pulmonary Arterial Hypertension (PAH) Patients
NCT ID: NCT06445673
Last Updated: 2024-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
110 participants
OBSERVATIONAL
2024-07-31
2030-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TripleTRE NIS patients
all patients previously treated within the TripleTRE trial who are willing to participate in this NIS
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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)
18 Years
ALL
No
Sponsors
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AOP Orphan Pharmaceuticals AG
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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TREV1-10P.NIS
Identifier Type: -
Identifier Source: org_study_id
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