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

Phase 2

Completed

Conditions: Dilated cardiomyopathy
heart failure
10028593

Registration Number: NL-OMON43626

Lead Sponsor: Ethicare GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

-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.

Exclusion Criteria

-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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The bioavailability of enalapril and its active metabolite enalaprilat in the<br /><br>paediatric population (AUC from 0 to time of last sampling point, Cmax and<br /><br>Tmax); descriptive pharmacokinetic investigation.</p><br>

Secondary Outcome Measures