Pulmonary arterial hypertension associated with congenital heart disease
Conditions
Interventions
Group-iNO:NO inhalation
Group-controll:conventional therapy
Sponsors
Shanghai Children’s Medical Center, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: (1) Age = 0.75 measured by cardiac catheter before operation or Pp/Ps >= 0.5 after operation (5) Informed consent signed by the legally recognized representative (parent or guardian) of the child according to local regulations
Exclusion criteria
Exclusion criteria: Exclusion criteria (1) Allergy to iNO or its analogues (2) Pulmonary venous obstruction, severe mitral stenosis (3) Severe left ventricular insufficiency, acute pulmonary edema (4) Active bleeding that increases the risk of bleeding (hemorrhagic diseases such as hemophilia, vascular hemophilia, arteriovenous malformations, aneurysms) or previous intracranial bleeding or life-threatening bleeding (5) Currently, there is clinically significant or persistent thrombocytopenia (PLT<50 × 109/L) (6) Failure to follow the study procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the incidence of malignant clinical events (including death, pulmonary hypertension crisis, and severe reactive pulmonary hypertension) between the two groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| pulmonary arterial pressure;Arterial blood gas analasys; | — |
Countries
China
Contacts
Public ContactHao Zhang
Shanghai Children’s Medical Center, Shanghai Jiaotong University School of Medicine
Outcome results
None listed