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El ensayo clínico NCT07495774 (INSPIRE-PPH) para Hipertensión pulmonar está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Insights Into Pediatric Pulmonary Hypertension: A Real-World Registry of Epidemiology and Outcomes (INSPIRE-PPH) 450 Evidencia mundo real Pediátrico Adolescentes Observacional
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07495774 (INSPIRE-PPH) es un estudio observacional para Hipertensión pulmonar. Su estado actual es: reclutando. El estudio se inició el 4 de enero de 2006, con el objetivo de reclutar a 450 participantes. Dirigido por Guangdong Provincial People's Hospital, se espera que finalice el 31 de diciembre de 2035. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de marzo de 2026.
Resumen
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...
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Insights Into Epidemiology, Management, and Outcomes of Pediatric Pulmonary Hypertension: The INSPIRE-PH Multicenter Real-World Registry
Condiciones médicas
Hipertensión pulmonarOtros ID del estudio
- INSPIRE-PPH
- INSPIRE-PPH-Registry
Número del NCT
Inicio del estudio (real)
2006-01-04
Última actualización
2026-03-27
Fecha de finalización (estimada)
2035-12-31
Inscripción (prevista)
450
Tipo de estudio
Observacional
Estado general
Reclutando
Palabras clave
pediatric
pulmonary hypertension
real-world
epidemiology
outcome
pulmonary hypertension
real-world
epidemiology
outcome
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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) |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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) |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Niño, Adulto
Criterios de sexo
Todos
- 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 responsable del estudio
Zhi-Cheng Jing, MD, Investigador principal, Prof., Guangdong Provincial People's Hospital
Contactos centrales del estudio
Contacto: Jie-Xin Zhang, Dr., +86-18629534652, [email protected]
1 Centros del estudio en 1 países
Guangdong
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510080, China
Reclutando