EUCTR2015-002335-17-DE进行中（未招募）1 期
ORODISPERSIBLE MINITABLETS OF ENALAPRIL IN CHILDREN WITH HEARTFAILURE DUE TO DILATED CARDIOMYOPATHY - WP8
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 ? 25% in patients, resulting from different types of underlying cardiac diseases with signs of decreased systolic LV function, and 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.
- •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: 25
- •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
排除标准
- •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.
研究者
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