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

NCT07495774 | Recruiting

• 1 other identifier: INSPIRE-PPH-Registry
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pulmonary Hypertension

Keywords

pediatric; pulmonary hypertension; real-world; epidemiology; outcome

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (5)

• 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

  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)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This registry includes children and adolescents diagnosed with PH who are enrolled at participating centers. Patients are followed longitudinally with standardized collection of clinical, functional, imaging and hemodynamic data, with treatment strategies in a real-world setting, allowing evaluation of epidemiology, disease progression, and long-term outcomes.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zhi-Cheng Jing, Prof.

  Guangdong Provincial People's Hospital

  STUDY CHAIR

• Shu-Shui Wang, Prof.

  Guangdong Provincial People's Hospital

  STUDY DIRECTOR

• Jie-Xin Zhang, Dr.

  Guangdong Provincial People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Jie-Xin Zhang, Dr.

CONTACT

+86-18629534652; jx_zhang_vip@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start: January 4, 2006
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2035
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CN (1)