TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends
26 de julio de 2026 actualizado por: AOP Orphan Pharmaceuticals AG
Multicenter Registry Evaluating Real-World Therapeutic Patterns and Outcomes in Newly Diagnosed Adult Patients With Pulmonary Arterial Hypertension (PAH) Treated With Parenteral Treprostinil
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
300
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra de probabilidad
Población de estudio
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.
Descripción
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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean Change From Baseline in 6-Minute Walk Distance at Month 12
Periodo de tiempo: 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.
|
Baseline and Month 12
|
|
Number and Percentage of Participants by Change in New York Heart Association Functional Class at Month 12
Periodo de tiempo: 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.
|
Baseline and Month 12
|
|
Number and Percentage of Participants With Local Administration-Site Reactions During the First 12 Months
Periodo de tiempo: 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.
|
From baseline through Month 12
|
|
Mean Local Pain Score During the First 12 Months
Periodo de tiempo: 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.
|
Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, and Month 12
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean Change From Baseline in N-Terminal Pro-B-Type Natriuretic Peptide at Month 12
Periodo de tiempo: Baseline and Month 12
|
Mean change in N-terminal pro-B-type natriuretic peptide concentration from baseline to Month 12.
|
Baseline and Month 12
|
|
Mean Change From Baseline in B-Type Natriuretic Peptide at Month 12
Periodo de tiempo: Baseline and Month 12
|
Mean change in B-type natriuretic peptide concentration from baseline to Month 12.
|
Baseline and Month 12
|
|
Overall survival
Periodo de tiempo: 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.
|
From initiation of parenteral treprostinil until death from any cause, assessed up to 36 months
|
|
Number and Percentage of Participants by Reason for Early Initiation of Parenteral Treprostinil
Periodo de tiempo: 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.
|
Baseline
|
|
Mean Parenteral Treprostinil Dose at each visit
Periodo de tiempo: 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.
|
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 by Route of Parenteral Treprostinil Administration
Periodo de tiempo: 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.
|
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 Concomitant Pulmonary Arterial Hypertension Therapy
Periodo de tiempo: 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.
|
Baseline, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
|
|
Time to First Composite Clinical Worsening Event
Periodo de tiempo: 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.
|
From initiation of parenteral treprostinil until the first composite clinical worsening event, assessed up to 36 months
|
|
Number and Percentage of Participants With Adverse Events
Periodo de tiempo: 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.
|
From baseline through Month 36
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de diciembre de 2029
Finalización del estudio (Estimado)
1 de diciembre de 2031
Fechas de registro del estudio
Enviado por primera vez
20 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de julio de 2026
Publicado por primera vez (Actual)
30 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TRESPECT
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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