Follow-up Safety Trial in children with chronic heart failure therapy receiving Orodispersible Minitablets of Enalapril (WP10 Trial).

Phase 2

Completed

Conditions: hartaandoeningen, myocardaandoeningen
Congenital Heart Disease
Dilated Cardiomyopathy
10010394

Registration Number: NL-OMON46324

Lead Sponsor: Ethicare GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 11

Inclusion Criteria

-Patients from the WP08 and WP09 trials who have been treated with enalapril Orodispersible Minitablets and are still under ODMT treatment.
-Patients from the WP08 and WP09 trials who have been treated for at least 3 days with enalapril Orodispersible Minitablets and are not anymore under ODMT treatment.
-Patient and/or parent(s)/legal representative provided written informed consent for participation in this long term follow-up study and assent is received from the patient according to national legislation and as far as achievable from the child.

Exclusion Criteria

Patients who have been enrolled and treated in the WP08 or WP09 trials have fulfilled the respective in- and exclusion criteria of those protocols. As it is the aim of this Follow-up Study to observe the safety of all patients exposed to enalapril ODMT treatment, no additional exclusion criteria are defined in this protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Any adverse events. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Blood pressure in paediatric patients under and after enalapril ODMT<br /><br>treatment.<br /><br>2. Renal function in paediatric patients under and after enalapril ODMT<br /><br>treatment.<br /><br>3. Exploratory pharmacokinetics and pharmacodynamics in paediatric patients<br /><br>under enalapril ODMT treatment.<br /><br>4. Acceptability and palatability of the novel formulation in paediatric<br /><br>patients under enalapril ODMT treatment.<br /><br>5. Rehospitalisation due to heart failure including the need for heart<br /><br>transplantation or the institution of mechanical circulatory support.<br /><br>6. Death due to worsening of the underlying disease.<br /><br>7. Echocardiography (Shortening Fraction). </p><br>