Orodispersible Minitablets of Enalapril in young children with Heart Failure due to Congenital Heart Disease (WP09 Trial) - WP09 Trial

Ethicare GmbH0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•- Age from birth to 6 years.
•- Male and female patients.
•- Weight greater than 2.5 Kg.
•- Diagnosis of heart failure due to congenital heart disease requiring after load reduction by drug therapy.
•- 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 and assent from the patient received according to national legislation and as far as achievable from the child.
•- Permitted: other CHF medications are allowed, at the discretion of the investigator. These include but are not limited to diuretics, beta-blockers, digoxin, mineralocorticoid receptor antagonist, aspirin and paracetamol.

•- Neonates if born < 37 weeks gestation.
•- Severe HF and/or end stage heart failure requiring ICU support precluding introduction or continuation of ACEI.
•- Too low blood pressure, e.g. - Uncorrected primary obstructive valvular disease, or significant systemic ventricular outflow obstruction, dilated restrictive or hypertrophic cardiomyopathy.
•- Uncorrected severe peripheral stenosis of large arteries including severe coarctation of the aorta.
•- Severe renal impairment with 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 an interventional trial with an investigational drug, unless no interference with the current study can be shown.

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