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TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends

26 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Stimato)

300

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Droga: treprostinil
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.
Altri nomi:
  • Parenteral Treprostinil
  • Subcutaneous Treprostinil
  • Intravenous Treprostinil

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change From Baseline in 6-Minute Walk Distance at Month 12
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change From Baseline in N-Terminal Pro-B-Type Natriuretic Peptide at Month 12
Lasso di tempo: 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
Lasso di tempo: Baseline and Month 12
Mean change in B-type natriuretic peptide concentration from baseline to Month 12.
Baseline and Month 12
Overall survival
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AOP Orphan Pharmaceuticals AG

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 dicembre 2029

Completamento dello studio (Stimato)

1 dicembre 2031

Date di iscrizione allo studio

Primo inviato

20 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 luglio 2026

Primo Inserito (Effettivo)

30 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TRESPECT

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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