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Clinical Trial NCT07495774 (INSPIRE-PPH) for Pulmonary Hypertension is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Insights Into Pediatric Pulmonary Hypertension: A Real-World Registry of Epidemiology and Outcomes (INSPIRE-PPH) 450 Real-World Evidence Pediatric Adolescent Observational
Clinical Trial NCT07495774 (INSPIRE-PPH) is an observational study for Pulmonary Hypertension that is recruiting. It started on January 4, 2006 with plans to enroll 450 participants. Led by Guangdong Provincial People's Hospital, it is expected to complete by December 31, 2035. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
Brief Summary
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...
Show MoreOfficial Title
Insights Into Epidemiology, Management, and Outcomes of Pediatric Pulmonary Hypertension: The INSPIRE-PH Multicenter Real-World Registry
Conditions
Pulmonary HypertensionOther Study IDs
- INSPIRE-PPH
- INSPIRE-PPH-Registry
NCT ID Number
Start Date (Actual)
2006-01-04
Last Update Posted
2026-03-27
Completion Date (Estimated)
2035-12-31
Enrollment (Estimated)
450
Study Type
Observational
Status
Recruiting
Keywords
pediatric
pulmonary hypertension
real-world
epidemiology
outcome
pulmonary hypertension
real-world
epidemiology
outcome
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult
Eligible Sexes
All
- 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 HospitalStudy Responsible Party
Zhi-Cheng Jing, MD, Principal Investigator, Prof., Guangdong Provincial People's Hospital
Study Central Contact
Contact: Jie-Xin Zhang, Dr., +86-18629534652, [email protected]
1 Study Locations in 1 Countries
Guangdong
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510080, China
Recruiting