Trial Radar IA | ||
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Lo studio clinico NCT07495774 (INSPIRE-PPH) per Ipertensione polmonare è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Insights Into Pediatric Pulmonary Hypertension: A Real-World Registry of Epidemiology and Outcomes (INSPIRE-PPH) 450 Dati real-world Pediatrico Adolescenti Osservazionale
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La sperimentazione clinica NCT07495774 (INSPIRE-PPH) è uno studio osservazionale per Ipertensione polmonare, attualmente in arruolamento. Avviato il 4 gennaio 2006, prevede di arruolare 450 partecipanti. Sotto la guida di Guangdong Provincial People's Hospital, dovrebbe concludersi entro il 31 dicembre 2035. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 marzo 2026.
Sommario breve
Pediatric pulmonary hypertension (PH) shares similarities with PH in adulthood, but specific differences still require unique approaches. Despite major advances, risk scores for pediatric PH still need to be validated, and targeted drug therapies in pediatric populations remain under-studied. Consequently, there is a great need for comprehensive real-world longitudinal data of pediatric PH.
The INSPIRE-PH registry i...
Mostra di piùTitolo ufficiale
Insights Into Epidemiology, Management, and Outcomes of Pediatric Pulmonary Hypertension: The INSPIRE-PH Multicenter Real-World Registry
Patologie
Ipertensione polmonareAltri ID dello studio
- INSPIRE-PPH
- INSPIRE-PPH-Registry
Numero NCT
Data di inizio (effettiva)
2006-01-04
Ultimo aggiornamento pubblicato
2026-03-27
Data di completamento (stimata)
2035-12-31
Arruolamento (previsto)
450
Tipo di studio
Osservazionale
Stato
In arruolamento
Parole chiave
pediatric
pulmonary hypertension
real-world
epidemiology
outcome
pulmonary hypertension
real-world
epidemiology
outcome
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
death | From enrollment to the event, assessed through study completion (target follow-up duration of 10 years; extended follow-up available for earlier enrollees) | |
transplantation | From enrollment to the event, assessed through study completion (target follow-up duration of 10 years; extended follow-up available for earlier enrollees) |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
PH-related hospitalization | From enrollment to first occurrence of the event, assessed through study completion (continue to be followed after event occurrence until primary outcome or study completion) | |
atrial septostomy | From enrollment to first occurrence of the event, assessed through study completion (continue to be followed after event occurrence until primary outcome or study completion) | |
Potts shunt | From enrollment to first occurrence of the event, assessed through study completion (continue to be followed after event occurrence until primary outcome or study completion) | |
clinical worsening | Clinical worsening is defined as the first occurrence of death, transplantation, hospitalization for PH, atrial septostomy or Potts shunt, with need for escalation of PH-targeted therapy, or worsening functional status. | From enrollment to first occurrence of the event, assessed through study completion (continue to be followed after event occurrence until primary outcome or study completion) |
decline in WHO functional class | From enrollment to first occurrence of the event, assessed through study completion (continue to be followed after event occurrence until primary outcome or study completion) |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Bambino, Adulto
Sessi idonei
Tutti
- Children and adolescents aged <18 years at diagnosis
- Diagnosed pulmonary hypertension (PH) according to the prevailing diagnostic criteria at the time of enrollment
- Enrollment in the registry at participating centers
- Provision of informed consent by patients and/or legal guardians
- Availability for longitudinal follow-up
- Inability to confirm PH diagnosis due to insufficient clinical or hemodynamic data
- Refusal or inability to provide informed consent
Guangdong Provincial People's HospitalParte responsabile dello studio
Zhi-Cheng Jing, MD, Investigatore principale, Prof., Guangdong Provincial People's Hospital
Contatti principali dello studio
Contatto: Jie-Xin Zhang, Dr., +86-18629534652, [email protected]
1 Centri dello studio in 1 paesi
Guangdong
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510080, China
In arruolamento