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

Phase 1

• Conditions: Heart Failure due to Dilated Cardiomyopathy; MedDRA version: 20.0Level: LLTClassification code 10056419Term: Dilated cardiomyopathySystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-002335-17-AT
• Lead Sponsor: Ethicare GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-19
• Last Update Posted: 1 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

•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 disease 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 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.

Permitted:
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.

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

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. below 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:
o Dual ACEI therapy
o Renin inhibitors
o Angiotensin II antagonists
o NSAIDs 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 clinical trial of medicinal product
• Study Design: Not specified