Comparison between beta-adrenergic blockers and angiotensin II receptor antagonists for the treatment of late hypertension in patients with repaired aortic coarctation - Treatment of late hypertension in aortic coarctatio

Conditions: Aortic coarctation and late hypertension

Registration Number: EUCTR2006-006861-18-NL

Lead Sponsor: Department of Cardiology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 20

Inclusion Criteria

-Diagnosis of aortic coarctation (EPCC code 09.29.01)
-Previous repair of aortic coarctation
-Age 18-80 years
-Current use of anti-hypertensive medication (<3 different drugs), or untreated hypertension, defined as systolic =140 mmHg of diastolic =90 mmHg

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Known oversensitivity for candesartan or metoprolol
-Severe liver insufficiency (ASAT or ALAT >3ULN)
-Current use of =3 anti-hypertensive drugs
-Pregnancy or wish to become pregnant
-General contraindications for use of candesartan
-General contraindications for use of metoprolol (i.e. bradycardia, sick sinus syndrome etc)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether treatment with the ARB, candesartan, reduce 24-hours systolic BP more effectively than treatment with the betablocker metoprolol in patients with repaired aortic coarctation and late hypertension ;Secondary Objective: To investigate whether treatment with the ARB, candesartan, reduce arterial stiffness as assessed by aortic pulse wave velocity (PWV) more effectively than treatment with the betablocker metoprolol in patients with repaired aortic coarctation and late hypertension <br>To investigate the effects of the antihypertensive agents on several hormones, including components of the renin-angiotensin-aldosteron system, catecholamines and NT-proBNP.<br>;Primary end point(s): Reduction in 24-hours systolic blood pressure after 8 weeks of active treatment with either candesartan or metoprolol.

Secondary Outcome Measures