pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease
Conditions
Interventions
All groups:Bosentan therapy
Sponsors
Beijing Anzhen Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1) Signed informed consent prior to initiation of any study-mandated procedure2)Males or females =6 woods; 5) Congenital heart disease, including: VSD, ASD, PDA, CAVSD, and the combination of any of these conditions; 6) Didn't receive endothelin receptor antagonists, or prostanoids within 3 months prior to entering this study (except medication used for vaso-reaction test); 7) Patients received PDE-5 inhibitors should be in stable dosage at least 3 months prior to entering this study.
Exclusion criteria
Exclusion criteria: 1. Patient with Eisenmenger syndrome; 2. Patients with known pulmonary lung disease or idiopathic pulmonary arterial hypertension; 3. Patients with uncorrected hemorrhagic disease or severe liver disease; 4. Patients who have hemodynamic instability; 5. Participated or planed to participate in other clinical studies within 3 months prior to entering this study; 6. Received endothelin receptor antagonists, or prostanoids within 3 months prior to entering this study (excluding drugs used in acute drug studies).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PVR; | — |
Countries
China
Contacts
Public ContactHong Gu
Outcome results
None listed