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Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension

NCT02610660 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 388

Last updated 2023-04-13

No results posted yet for this study

Summary

The TOPP-2 registry is an international, non-interventional, prospective registry including children and adolescents newly diagnosed with pulmonary hypertension (PH) to gain further insights in the disease course and long-term outcome of PH in childhood.

Patients will undergo clinical assessments and receive standard medical care, as determined by treating physicians in their daily clinical practice. The TOPP-2 registry is specifically designed to capture the variables that have been proposed as treatment goals in PePH and the reasons for changes in treatment strategy.

The TOPP-2 registry uses the new clinical classification of PH as outlined at the 5th World Symposium for Pulmonary Hypertension (WSPH) in Nice 2013 and includes new characterizations for children with PH.

The registry is planned and implemented under the scientific leadership of the Association for Pediatric Pulmonary Hypertension (PePH), independently from the financial sponsors.

All enrolled patients will have a follow-up period of 18 months.

Conditions

  • Hypertension, Pulmonary

Sponsors & Collaborators

  • Association for Pediatric Pulmonary Hypertension

    lead OTHER

Principal Investigators

  • Dunbar Ivy, Prof · Association for Pediatric Pulmonary Hypertension

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • China
  • Colombia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Saudi Arabia
  • Sweden
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02610660 on ClinicalTrials.gov