Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07736846

TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pulmonary Arterial Hypertension (PAH) Hypertension, Pulmonary Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Parenteral Treprostinil, Subcutaneous Treprostinil, Intravenous Treprostinil

Primary outcomes

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

    Time frame: Baseline and 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.

  2. 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 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.

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

    Time frame: From baseline through Month 12

    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.

  4. 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

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

Other outcomes

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

    Time frame: Baseline and Month 12

    Mean change in N-terminal pro-B-type natriuretic peptide concentration from baseline to Month 12.

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

    Time frame: Baseline and Month 12

    Mean change in B-type natriuretic peptide concentration from baseline to Month 12.

  3. Overall survival

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

    Overall survival is defined as the time from initiation of parenteral treprostinil to death from any cause.

  4. Number and Percentage of Participants by Reason for Early Initiation of Parenteral Treprostinil

    Time frame: Baseline

    Number and percentage of participants in each documented category of clinical reason for initiating parenteral treprostinil within 12 months of PAH diagnosis, irrespective of baseline risk category.

  5. Mean Parenteral Treprostinil Dose at each visit

    Time frame: Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36

    Parenteral treprostinil dose will be summarized at each visit. Dose will be reported in the unit ng/kg/min.

  6. Number and Percentage of Participants by Route of Parenteral Treprostinil Administration

    Time frame: Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36

    Number and percentage of participants receiving parenteral treprostinil by subcutaneous or intravenous administration at each visit.

  7. Number and Percentage of Participants Receiving Concomitant Pulmonary Arterial Hypertension Therapy

    Time frame: Baseline, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36

    Number and percentage of participants receiving each recorded category of concomitant pulmonary arterial hypertension therapy.

  8. Time to First Composite Clinical Worsening Event

    Time frame: From initiation of parenteral treprostinil until the first composite clinical worsening event, assessed up to 36 months

    Time from initiation of parenteral treprostinil to the first occurrence of death from any cause, PAH-related hospitalization, or lung transplantation.

  9. Number and Percentage of Participants With Adverse Events

    Time frame: From baseline through Month 36

    Number and percentage of participants experiencing at least one adverse event during registry follow-up. Adverse events will be summarized by seriousness, severity, outcome, causal relationship to treprostinil, and action taken with treatment.

Sponsors and collaborators

Lead sponsor

AOP Orphan Pharmaceuticals AG

Industry

Registry information

Official study title

Multicenter Registry Evaluating Real-World Therapeutic Patterns and Outcomes in Newly Diagnosed Adult Patients With Pulmonary Arterial Hypertension (PAH) Treated With Parenteral Treprostinil

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.