ORODISPERSIBLE MINITABLETS OF ENALAPRIL IN CHILDREN WITH HEARTFAILURE DUE TO DILATED CARDIOMYOPATHY - ENADCM

Ethicare GmbH0 个研究点目标入组 50 人开始时间: 2015年10月5日最近更新: 2018年9月3日

适应症

试验速览

暂无简介。

•Age 1 month to <12 years.
•Male and female patients.
•Diagnosis of DCM presenting with LV end-diastolic dimension >? P95 and/or LV shortening fraction (SF) 25% in patients without ACE Inhibitor treatment; patients with ACE Inhibitor pre-treatment must have documented evidence of having fulfilled these criteria before start of the ACE Inhibitor therapy<br•Subjects may be naïve to ACEI.
•Subjects already on ACEI willing to switch to enalapril Orodispersable Minitablets.
•Patient and/or parent(s)/legal representative provided written informed consent.
•Other CHF medications will be allowed, at the discretion of the treating physician. These include but are not limited to diuretics, beta-blockers, digoxin, mineralocorticoid receptor antagonist, aspirin and paracetamol.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 50
•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

•Severe HF and/or end stage heart failure precluding introduction or continuation of ACEI.
•Too low blood pressure, e.g. ?P5.
•Restrictive and hypertrophic cardiomyopathies.
•Obstructive valvular disease (peak echocardiographic gradient more than 30 mm Hg).
•Uncorrected severe peripheral stenosis of large arteries including severe coarctation of the aorta.
•Severe renal impairment with serum creatinine >2x ULN (Upper Limit of Normal) according to the hospital’s test methodology).
•History of angioedema.
•Hypersensitivity to ACEI.
•Concomittant medication:
•oDual ACEI therapy
•oRenin inhibitors
•oAngiotensin II antagonists
•oNSAIDs except acetylsalicylic acid only for antiplatelet therapy
•Already enrolled in an interventional trial with an investigational drug, unless no interference with the current study can be shown.

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