ORODISPERSIBLE MINITABLETS OF ENALAPRIL IN YOUNG CHILDREN WITH HEART FAILURE DUE TO CONGENITAL HEART DISEASE

Phase 1

• Conditions: Heart Failure due to Congenital Heart Disease; MedDRA version: 18.1Level: LLTClassification code 10010495Term: Congenital heart disease NOSSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-002396-18-HU
• Lead Sponsor: Ethicare GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-29
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•Age from birth to less than 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 ACE-Inhibitors (ACEI).
•Subjects already on ACE-Inhibitors willing to switch to Enalapril Orodispersable Minitablets.
•Patient and/or parent(s)/legal representative provided written informed consent.

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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 50
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

•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. below P5
•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 a GFR below 30 ml/1.73 m2 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 for aspirin 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified