Arterial Hypertension After Successful Aortic Decoarctation: Atenolol vs Enalapril Comparison of Efficacy and Tolerability in Pediatric Age. - Antihypertensive treatment and aortic coarctatio

Conditions: Aortic coarctation and hypertensive patients
MedDRA version: 9.1Level: SOCClassification code 10007541

Registration Number: EUCTR2010-023206-12-IT

Lead Sponsor: AZIENDA OSPEDALIERA VINCENZO MONALDI DI NAPOLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

eligible patients will be aortic coarctation hypertensive pediatric patients aged between 6 and 16 years, BMI < 90? pc for age and sex, > 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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures