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NCT07736846
TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends
Conditions: Pulmonary Arterial Hypertension (PAH)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 300
Sponsor: AOP Orphan Pharmaceuticals AG
Summary
TRESPECT is an international, multicenter, observational registry designed to describe the real-world use, effectiveness, and tolerability of parenteral treprostinil in adults with newly diagnosed pulmonary arterial hypertension (PAH). The registry will include patients who initiated subcutaneous or intravenous treprostinil within 12 months of PAH diagnosis.
Both retrospective and prospective data will be collected from routine clinical care. Data will include patient characteristics, PAH treatment patterns, treprostinil dosing and route of administration, functional status, exercise capacity, biomarkers, echocardiographic and hemodynamic parameters, clinical events, and adverse events. Participants will be followed for at least 36 months or until a registry termination criterion is met. The registry is expected to enroll approximately 100 to 300 patients across specialized PAH centers in several European countries.
Eligibility Criteria
Inclusion Criteria:
* Adult patient (≥18 years)
* Confirmed diagnosis of PAH (i.e. Group 1 as defined by ESC/ERS guidelines)
* Initiated on parenteral Treprostinil (SC or IV) anytime from 1/1/2024
* Informed consent (prospective data or retrospective chart review, per local regulations)
Exclusion Criteria:
* Participation in any interventional trials affecting PAH (including patients from TripleTRE study)
* Non-PAH forms of pulmonary hypertension (e.g., ESC-ERS Group 2-5)
Source: ClinicalTrials.gov (NCT07736846). StuddyBuddy aggregates publicly available trial information.