Subjects in children with congenital heart disease surgery or not, with echocardiographic signs of pulmonary hypertension followed at the Pediatric Cardiology Centre of the Mediterranean or reported by other centers I and Level II. MedDRA version: 14.1 Level: SOC Classification code 10047065 Term: Vascular disorders System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: REVATIO*EV 1FL 20ML 0,8MG/ML
Pharmaceutical Form: Solution for injection
CAS Number: 139755-83-
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: up to
Concentration numb
Sponsors
OSPEDALE PEDIATRICO BAMBINO GESU' DI ROMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: subjects in children with congenital heart disease surgery or not, with echocardiographic signs of pulmonary hypertension followed at the Pediatric Cardiology Centre of the Mediterranean or reported by other centers I and Level II. Are the trial subjects under 18? yes Number of subjects for this age range: 13 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: NA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: reducing the invasiveness of the procedure, with less intubation / sedation, which is necessary for proper administration of nitric oxide, especially in adolescent patients; - Significant reduction of costs; - Assessing the effectiveness of all, useful prognostic sense and proper therapeutic management in the future.;Main Objective: assess the appropriateness, sensitivity and specificity of sildenafil ev in reducing pulmonary hypertension and its possible superiority in terms of results / costs / organizational aspects than nitric oxide during the execution of the test vessel pulmonary artery reactivity.;Primary end point(s): assessment in cardiac patients with pulmonary hypertension tested for pulmonary vessel reactivity in absolute terms and compared the effectiveness of nitric oxide, sildenafil ev in determining improvement of: - Blood pressure in the pulmonary artery; - Pulmonary capillary pressure; - Transpulmonary gradient; - Flow rate (measured by the method of thermodilution or the Fick principle); - Heating lung total arteriolar and venous capillaries.;Timepoint(s) of evaluation of this end point: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Reducing the invasiveness of the procedure, with less intubation / sedation, which is necessary for proper administration of nitric oxide, especially in adolescent patients; - Significant reduction of costs; - Assessing the effectiveness of all, useful prognostic sense and proper therapeutic management in the future.;Timepoint(s) of evaluation of this end point: na | — |
Countries
Italy
Contacts
Public ContactCardiologia
Ospedale Pediatrico Bambino Gesù
Outcome results
None listed