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NCT Number: NCT07495774

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

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. death

    Time frame: From enrollment to the event, assessed through study completion (target follow-up duration of 10 years; extended follow-up available for earlier enrollees)

  2. transplantation

    Time frame: 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

  1. PH-related hospitalization

    Time frame: 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)

  2. atrial septostomy

    Time frame: 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)

  3. Potts shunt

    Time frame: 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)

  4. clinical worsening

    Time frame: 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 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.

  5. decline in WHO functional class

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jie-Xin Zhang, Dr.

CONTACT

[email protected]

+86-18629534652

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

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

Acronym: INSPIRE-PPH

Important dates

Study start
2006
Primary completion
2032
Study completion
2035
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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