Oridispersible Minitablets of Enalapril in Children With Heart Failure due to Dilated Cardiomyopathy (WP08 Trial) - WP08 Trial

Ethicare GmbH0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•-Age 1 month to <12 years.
•-Male and female patients.
•-Diagnosis of heart failure due to 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 havingfulfilled these criteria before start of the ACE Inhibitor therapy.
•-Subjects may be naïve to ACEI.
•-Subjects already on ACEI willing to switch to enalapril Orodispersible Minitablets.
•-Patient and/or parent(s)/legal representative provided written informed consent and assent from the patient received according to national legislation and as far as achivable from the child. ;Permitted:
•Other DCM 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.

•-Severe HF and/or end stage heart failure requiring ICU support 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 a Serum creatinine >2x ULN
•-History of Angioedema.
•-Hypersensitivity to ACEI.
•-Concomittant medication:
•o Dual ACEI therapy
•o Renin inhibitors
•o Angiotensin II antagonists
•o NSAIDs (including ibuprofen) except acetylsalicylic acid only for antiplatelet therapy
•-Already enrolled in interventional trial with an investigational drug, unless no interference with current study can be shown.

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