Follow-up Safety Trial in Children With Chronic Heart Failure Therapy Receiving Orodispersible Minitablets of Enalapril

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Brief Title

Follow-up Safety Trial in Children With Chronic Heart Failure Therapy Receiving Orodispersible Minitablets of Enalapril

Official Title

Follow-up Safety Trial in Children With Chronic Heart Failure Therapy Receiving Orodispersible Minitablets of Enalapril

Brief Summary

      Paediatric long-term safety follow-up clinical trial in maximum 100 children with heart
      failure due to dilated cardiomyopathy or congenital heart disease, from 1 day to less than 12
      years of age at recruitment into the preceding short-term pharmacokinetic
      (PK)/pharmacodynamic (PD) trials. Pharmacodynamic measurements and renal monitoring in all
      children after 1 , 4, 7 and 10 months of follow-up; in addition PK assessments as well as
      acceptability and palatability assessments in children still under enalapril Orodispersible
      Minitablet (ODMT) treatment.
    

Detailed Description

      This clinical trial is one of three clinical trials of the European Commission (FP7)-funded
      "LENA" (Labeling of Enalapril from Neonates to Adolescents) project: 50 children with heart
      failure due to dilated cardiomyopathy (LENA-Work Package (WP)08 Trial) and 50 children with
      heart failure due to congenital heart disease (LENA-WP09 Trial) get treated with an optimal
      dose of enalapril ODMTs for up to 8 weeks after thorough, individualised titration and get
      invited to join this 10 months Safety Follow-up Study (LENA-WP10 Trial).

      Reliable data on the long-term safety of enalapril in paediatric patients are currently not
      available. By conducting this long-term Safety Follow-up Trial in children who received or
      still receive enalapril Orodispersible Minitablets at the end of the 8-weeks PK/PD LENA-Work
      Package (WP)08 (children with heart failure due to dilated cardiomyopathy) and LENA-WP09
      (children with heart failure due to congenital heart disease) Trials using sensitive and
      highly specific assay methodology, it will be possible to add to the generation of reliable
      PK and PD data in the whole paediatric age range from birth to 12 years. In addition, this
      follow-up study will allow to systematically collect follow-up information over 10 more
      months, so in total 12 months, in paediatric patients under long-term enalapril ODMT
      treatment and in paediatric patients who had received at least 3 days of ODMT treatment but
      then stopped for any reason.

      The End-of-study Visit of the WP08 and WP09 Trials is also the First Visit of the Follow-up
      Study. Further Visits occur after 1 month, 4 months, 7 months and 10 months.

      At each Visit blood pressure and renal monitoring as well as pharmacodynamic parameters and
      adverse events are assessed. In children under ongoing enalapril ODMT treatment, single PK
      sampling as well as acceptability and palatability assessments are made at each Visit.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Number of patients with Adverse Reactions

Secondary Outcome

 Blood pressure

Condition

Heart Failure

Intervention

Enalapril Orodispersible Minitablet

Study Arms / Comparison Groups

 Enalapril Orodispersible Minitablets
Description:  Individually adapted dose of enalapril consisting of 1 to maximum 4 enalapril ODMTs of 0.25 mg and/or 1 mg and/or other prescribed treatment of heart failure.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

March 2016

Completion Date

April 2018

Primary Completion Date

April 2018

Eligibility Criteria

        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 no longer under ODMT treatment.

          -  Written informed consent from parent(s)/legal representative provided written informed
             consent for participation in this long term follow-up study and assent 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. However, adapted to the
        health situation of the patient, the investigator will decide whether planned study
        activities can be performed.
      

Gender

All

Ages

8 Weeks - 12 Years

Accepts Healthy Volunteers

No

Contacts

Saskia N. de Wildt, MD,PhD, +49 211 8110740, [email protected]

Location Countries

Austria

Location Countries

Austria

Administrative Informations


NCT ID

NCT02654678

Organization ID

2015-602295-03

Secondary IDs

2015-002397-21

Responsible Party

Sponsor

Study Sponsor

Ethicare GmbH


Study Sponsor

Saskia N. de Wildt, MD,PhD, Study Chair, Sophia Children's Hospital, Erasmus MC


Verification Date

January 2016