Health TrialsbyHealthPanel

TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends

ConditionPulmonary Arterial Hypertension (PAH)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAOP Orphan Pharmaceuticals AG

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Patients Treated With Parenteral Treprostinil1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

Other outcomes

1

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

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

Time frame
Baseline and Month 12
2

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

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

Time frame
Baseline and Month 12
3

Overall survival

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

Time frame
From initiation of parenteral treprostinil until death from any cause, assessed up to 36 months
4

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

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.

Time frame
Baseline

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AOP Orphan Pharmaceuticals AG

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: