Aortic coarctation and hypertensive patients MedDRA version: 9.1 Level: SOC Classification code 10007541
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Atenolol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical Form: Tablet
INN or Proposed INN: Ena
Sponsors
AZIENDA OSPEDALIERA VINCENZO MONALDI DI NAPOLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: eligible patients will be aortic coarctation hypertensive pediatric patients aged between 6 and 16 years, BMI 12 months from coarctation reapair major associated cardiovascular abnormalities, such as ventricular septal defect and aortic and mitral valve functional abnormalities, without evidence of recoarctation (>20 mmHg pressure gradient at continuous Doppler in the aortic arch and the presence of a diastolic tail), and no evidence of aortic aneurysms at the last outpatient visit. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: major associated cardiovascular abnormalities, such as ventricular septal defect and aortic and mitral valve functional abnormalities (more than mild), evidence of recoarctation (>20 mmHg pressure gradient at continuous Doppler in the aortic arch and the presence of a diastolic tail), and no evidence of aortic aneurysms at the last outpatient visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the tolerability and efficacy, in terms of lowering blood pressure and reducing target organ damage, of oral administration of atenolol vs enalapril, in hypertensive pediatric patients or young adult late after successful decoarctation.;Secondary Objective: To assess if the different RAS genetic polymorphism may influence the pathogenesis of late hypertension and the response to different medical treatments.;Primary end point(s): Lowering blood pressure Lowering target organ damages. | — |
Countries
Italy
Outcome results
None listed