TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends

NCT07736846 | Not Yet Recruiting

• 1 other identifier: TRESPECT
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

Pulmonary Arterial Hypertension; Treprostinil; Parenteral Treprostinil; Subcutaneous Treprostinil; Observational Registry

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, and Month 12

Other Outcomes (9)

• Mean Change From Baseline in N-Terminal Pro-B-Type Natriuretic Peptide at Month 12

  Baseline and Month 12

• Mean Change From Baseline in B-Type Natriuretic Peptide at Month 12

  Baseline and Month 12

• Overall survival

  From initiation of parenteral treprostinil until death from any cause, assessed up to 36 months

Study Arms (1)

Patients Treated With Parenteral Treprostinil

Adult patients with confirmed pulmonary arterial hypertension who initiated parenteral treprostinil administered by the subcutaneous or intravenous route within 12 months of PAH diagnosis. Treatment selection, route of administration, dosing, titration, concomitant PAH therapy, and clinical management are determined by the treating physician according to routine clinical practice. Clinical, treatment, safety, and outcome data are collected retrospectively and/or prospectively as part of this observational registry.

Drug: treprostinil

Interventions

treprostinil DRUG

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.

Also known as: Parenteral Treprostinil, Subcutaneous Treprostinil, Intravenous Treprostinil

Patients Treated With Parenteral Treprostinil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The registry will include approximately 100-300 adult patients (≥18 years of age) with confirmed pulmonary arterial hypertension (PAH), classified as Group 1 according to the prevailing ESC/ERS guidelines, who initiated parenteral treprostinil administered subcutaneously or intravenously on or after January 1, 2024. Written informed consent will be required for prospective data collection and for retrospective medical chart review, as applicable under local regulations.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• AOP Orphan Pharmaceuticals AG: lead

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2031
• Last Updated: July 30, 2026

Record last verified: 2026-07