TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends

N/ANot Yet RecruitingNCT07736846

AOP Orphan Pharmaceuticals AG300 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Pulmonary Arterial Hypertension (PAH)

Interventions

treprostinilDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Mean Change From Baseline in 6-Minute Walk Distance at Month 12

Mean change in 6-minute walk distance from baseline to Month 12. The 6-minute walk distance is measured in meters. A positive change indicates improvement in exercise capacity.

Time frame: Baseline and Month 12

Number and Percentage of Participants by Change in New York Heart Association Functional Class at Month 12

Number and percentage of participants whose New York Heart Association Functional Class improved, remained unchanged, or worsened from baseline to Month 12. Functional Class ranges from Class I to Class IV, with a higher class indicating greater functional limitation.

Time frame: Baseline and Month 12

Number and Percentage of Participants With Local Administration-Site Reactions During the First 12 Months

Number and percentage of participants experiencing at least one local administration-site reaction associated with subcutaneous or intravenous treprostinil application during the first 12 months after treatment initiation.

Time frame: From baseline through Month 12

Mean Local Pain Score During the First 12 Months

Local pain associated with parenteral treprostinil application will be assessed on a numerical rating scale from 0 to 10. Higher scores indicate greater pain.

Time frame: Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, and Month 12