A multicenter observational study on the efficacy and safety of selexipag in pediatric pulmonary arterial hypertension

A multicenter observational study on the efficacy and safety of selexipag in pediatric pulmonary arterial hypertension - A multicenter observational study of selexipag in pediatric PAH

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060071

Enrollment

Registered

2025-12-12

Start date

2025-05-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric pulmonary arterial hypertension

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following inclusion criteria 1. Patients aged 2 years or older but younger than 15 years 2. Patients who have undergone cardiac catheterization and have been diagnosed with pulmonary arterial hypertension 3. Patients who are newly initiated on selexipag therapy following its regulatory approval

Exclusion criteria

Exclusion criteria: Patients who meet at least one of the following criteria 1. Patients scheduled to undergo surgical repair during the observation period 2. Patients with Fontan circulation

Design outcomes

Primary

Measure	Time frame
1. Efficacy outcomes: changes in the following parameters from achievement of the maximum tolerated dose of selexipag through 24 weeks of follow-up - Hemodynamic data from catheterization (heart rate, pulmonary vascular resistance index, pulmonary artery pressure (mean, systolic, diastolic), wedge pressure, cardiac index, stroke volume index, mean right atrial pressure, mixed venous oxygen saturation, pulmonary to systemic resistance ratio, pulmonary to systemic flow ratio, arterial pressure (mean, systolic, diastolic), presence and type of sedation/anesthesia, oxygen level) - Echocardiographic parameters (tricuspid regurgitation velocity, tricuspid regurgitation pressure gradient, right ventricular systolic pressure, presence of pericardial fluid) - Exercise capacity (NYHA/WHO functional class, 6-minute walk distance) - Other clinical laboratory parameters (brain natriuretic peptide, N-terminal pro-brain natriuretic peptide) 2. Safety outcomes - Adverse events (headache, diarrhea, jaw pain, nausea, vomiting, flushing, others) - Serious adverse events	—

Measure

Time frame

1. Efficacy outcomes: changes in the following parameters from achievement of the maximum tolerated dose of selexipag through 24 weeks of follow-up - Hemodynamic data from catheterization (heart rate, pulmonary vascular resistance index, pulmonary artery pressure (mean, systolic, diastolic), wedge pressure, cardiac index, stroke volume index, mean right atrial pressure, mixed venous oxygen saturation, pulmonary to systemic resistance ratio, pulmonary to systemic flow ratio, arterial pressure (mean, systolic, diastolic), presence and type of sedation/anesthesia, oxygen level) - Echocardiographic parameters (tricuspid regurgitation velocity, tricuspid regurgitation pressure gradient, right ventricular systolic pressure, presence of pericardial fluid) - Exercise capacity (NYHA/WHO functional class, 6-minute walk distance) - Other clinical laboratory parameters (brain natriuretic peptide, N-terminal pro-brain natriuretic peptide) 2. Safety outcomes - Adverse events (headache, diarrhea, jaw pain, nausea, vomiting, flushing, others) - Serious adverse events

—

Countries

Japan

Contacts

Public ContactShinichi Takatsuki

Toho University Omori Medical Center Pediatrics Center (pediatrics)

s-taka@med.toho-u.ac.jp03-3762-4151

Outcome results