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Идёт набор NCT07495774

Insights Into Pediatric Pulmonary Hypertension: A Real-World Registry of Epidemiology and Outcomes

— Наблюдательное Pulmonary Hypertension

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Pulmonary Hypertension. Базовые параметры: до 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Insights Into Epidemiology, Management, and Outcomes of Pediatric Pulmonary Hypertension: The INSPIRE-PH Multicenter Real-World Registry

Обзор

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 is a multicenter, observational, real-world registry designed to systematically collect longitudinal clinical data on children and adolescents with PH. Patients enrolled in the registry receive standard clinical care determined by their treating physicians. No study-mandated interventions are imposed. Longitudinal observation of this cohort aims to provide important insights into disease progression, treatment effectiveness, and long-term prognosis in pediatric PH. The cohort was initially established prospectively in 2006, with all cases reclassified according to the 7th World Symposium for Pulmonary Hypertension (WSPH) criteria in 2024, and new patients continue to be prospectively enrolled. The registry is supervised by the principal investigator, independently from the financial sponsors.

Первичные конечные точки

  • death [Срок оценки: From enrollment to the event, assessed through study completion (target follow-up duration of 10 years; extended follow-up available for earlier enrollees)]
  • transplantation [Срок оценки: From enrollment to the event, assessed through study completion (target follow-up duration of 10 years; extended follow-up available for earlier enrollees)]
Вторичные конечные точки (5)
  • PH-related hospitalization [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • Inability to confirm PH diagnosis due to insufficient clinical or hemodynamic data
  • Refusal or inability to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Guangdong Provincial People's Hospital — Гуанчжоу

Идентификаторы

NCT: NCT07495774 · INSPIRE-PPH-Registry

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗