Pulmonary hypertension Circulatory System Pulmonary hypertension
Conditions
Interventions
Power calculations:
60% of patients reduce at least 20% the mean pulmonary arterial pressure after using powder papers of Sildenafil citrate (SC). To demonstrate that at least 80% of patients would pr
Sponsors
National Institute of Quality Control in Health - Oswaldo Cruz Foundation (Brazil)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children from 0 to 18 years old, either sex 2. Diagnosed as having PH associated with congenital heart disease 3. Needing cardiac catheterisation with sildenafil to evaluate the response to the drug as a decision criteria to cardiac surgery
Exclusion criteria
Exclusion criteria: Children will be excluded if: 1. The clinician believes that sildenafil represents an additional risk for the patient 2. The carrier refuses to sign the informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients in each group that reduce pulmonary arterial hypertension in at least 20% twenty minutes after the administration of sildenafil citrate 0.2 mg/kg, during cardiac catheterisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. At 20 minutes measured by cardiac catheterisation after administration of sildenafil citrate: 1.1. Pulmonary vascular resistance 1.2. Pulmonary vascular resistance/systemic vascular resistance 1.3. Oxygenation index or oxygen requirement 1.4. Cardiac output 1.5. Mean systemic arterial pressure and surgery indication based on the response to sildenafil 2. At 24 hours: any adverse events 3. At 2 months: cardiac surgery and death | — |
Countries
Brazil
Outcome results
None listed