Trial of beta blocker therapy (atenolol) vs. angiotensin II receptor blocker therapy (losartan) in individuals with Marfan syndrome - Marfan Trial

niversity Hospital Gent0 个研究点目标入组 600 人开始时间: 2006年12月6日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•To be eligible for this trial the subjects must meet all of the following inclusion criteria at the time of enrollment:
•1) Diagnosis of MFS according to Ghent criteria
•2) Age 6 months to 25 years.
•3) Aortic root Z-score > 3.0.
•4) Informed consent of parent(s) or legal guardian; informed consent or assent of subject as applicable.
•Are the trial subjects under 18? yes
•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) no
•F.1.3.1 Number of subjects for this age range

•To be eligible for this trial, the subjects must meet none of the following exclusion criteria at the time of enrollment:
•1) Prior aortic surgery.
•2) Aortic root dimension at the sinuses of Valsalva > 5 cm.
•3) Planned aortic surgery within 6 months of enrollment.
•4) Aortic dissection.
•5) Shprintzen-Goldberg syndrome
•6) Loeys-Dietz syndrome
•7) Therapeutic (e.g. for arrhythmia, ventricular dysfunction or valve regurgitation) rather than prophylactic use of ACE inhibitor, BB, or calcium channel blocker.
•8) History of angioedema while taking an ACE inhibitor or BB.
•9) Intolerance to losartan or other ARB that resulted in termination of therapy.
•10) Intolerance to atenolol or other BB that resulted in termination of therapy.
•11) Renal dysfunction (Creatinine >upper limit of age-related normal values).
•12) Asthma of sufficient severity to preclude the use of a BB: Chronic use of steroids and/or beta-adrenergic agents with exacerbations of asthma that are frequent (averaging three or more per year) or severe (requiring hospitalization).
•13) Diabetes mellitus.
•14) Pregnancy or planned pregnancy within 36 months of enrollment.
•15) Inability to complete study procedures including history of poor acoustic windows (inability to obtain accurate measurement of aortic root).

发起方

niversity Hospital Gent