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TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends

NCT07736846 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-07-30

No results posted yet for this study

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.

Conditions

  • Pulmonary Arterial Hypertension (PAH)

Interventions

DRUG

treprostinil

Parenteral treprostinil administered by continuous subcutaneous or intravenous infusion as part of routine clinical care. The decision to initiate treatment, route of administration, starting dose, dose titration, treatment duration, and use of concomitant PAH therapies are determined by the treating physician and are not assigned by the registry. Data on treatment initiation, doses at approximately 2 and 4 weeks, longitudinal dosing, route of administration, tolerability, local site reactions, pain, treatment changes, and clinical outcomes are collected during registry follow-up.

Sponsors & Collaborators

  • AOP Orphan Pharmaceuticals AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2029-12-31
Completion
2031-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07736846 on ClinicalTrials.gov