NCT02610660

Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 388 (actual)
• Sponsor: Association for Pediatric Pulmonary Hypertension · Academic / Other
• Sex: All
• Age: 3 Months – 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2015-08-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2015-11-20
• Last updated: 2023-04-13

Locations

32 sites across 18 countries: United States, Australia, Brazil, Canada, China, Colombia, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Saudi Arabia, Sweden, Switzerland