TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends
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
- The protocol lists: treprostinil.
- Who it may be relevant to
- Registry conditions: Pulmonary Arterial Hypertension (PAH). 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
- Center list to be confirmed — check the primary protocol.
- 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
Multicenter Registry Evaluating Real-World Therapeutic Patterns and Outcomes in Newly Diagnosed Adult Patients With Pulmonary Arterial Hypertension (PAH) Treated With Parenteral Treprostinil
Overview
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.
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,
Primary outcome measures
- Mean Change From Baseline in 6-Minute Walk Distance at Month 12 [Time frame: Baseline and Month 12]
- Number and Percentage of Participants by Change in New York Heart Association Functional Class at Month 12 [Time frame: Baseline and Month 12]
- Number and Percentage of Participants With Local Administration-Site Reactions During the First 12 Months [Time frame: From baseline through Month 12]
- Mean Local Pain Score During the First 12 Months [Time frame: Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, and Month 12]
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)
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
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07736846 · TRESPECT