TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends
26 de julho de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Observacional
Inscrição (Estimado)
300
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra de Probabilidade
População do estudo
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.
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean Change From Baseline in 6-Minute Walk Distance at Month 12
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean Change From Baseline in N-Terminal Pro-B-Type Natriuretic Peptide at Month 12
Prazo: 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
Prazo: Baseline and Month 12
|
Mean change in B-type natriuretic peptide concentration from baseline to Month 12.
|
Baseline and Month 12
|
|
Overall survival
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de julho de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2029
Conclusão do estudo (Estimado)
1 de dezembro de 2031
Datas de inscrição no estudo
Enviado pela primeira vez
20 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de julho de 2026
Primeira postagem (Real)
30 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TRESPECT
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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