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治験 NCT07495774 (INSPIRE-PPH)(対象:肺高血圧症)は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
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Insights Into Pediatric Pulmonary Hypertension: A Real-World Registry of Epidemiology and Outcomes (INSPIRE-PPH) 450 RWE 小児 思春期 観察研究

募集中
治験(臨床試験)の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします!「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07495774 (INSPIRE-PPH) は 観察研究 臨床試験 で、肺高血圧症 に関するものです。現在は 募集中 で、2006年1月4日 から開始しています。450 名の参加者 の募集が計画されています。この試験は Guangdong Provincial People's Hospital によって主導され、2035年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月27日 です。
概要
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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公式タイトル

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

疾患名
肺高血圧症
その他の研究識別子
  • INSPIRE-PPH
  • INSPIRE-PPH-Registry
NCT番号
開始日
2006-01-04
最終更新日
2026-03-27
終了予定日
2035-12-31
目標参加者数
450
試験の種類
観察研究
状況
募集中
キーワード
pediatric
pulmonary hypertension
real-world
epidemiology
outcome
主要評価項目
評価指標指標の説明時間枠
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)
副次評価項目
評価指標指標の説明時間枠
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)
参加アシスタント
適格基準

対象年齢
小児, 成人
対象性別
全て
  • 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 Hospital logoGuangdong Provincial People's Hospital
責任者
Zhi-Cheng Jing, MD, 主任研究者, Prof., Guangdong Provincial People's Hospital
試験中央連絡先
連絡先: Jie-Xin Zhang, Dr., +86-18629534652, [email protected]
1 1カ国の場所

Guangdong

Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510080, China
募集中