Orodispersible Minitablets of Enalapril in young children with Heart Failure due to Congenital Heart Disease (WP09 Trial)
- Conditions
- Congenital heart diseaseheart failure10010394
- Registration Number
- NL-OMON45974
- Lead Sponsor
- Ethicare GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
- Age from birth to 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 ACEI.
- Subjects already on ACEI willing to switch to Enalapril Orodispersable 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 achievable from the child.
- 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 and paracetamol.
- 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. - 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 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 an interventional trial with an investigational drug, unless no interference with the 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 young<br /><br>children (AUC from 0 to time of last sampling point, Cmax and Tmax);<br /><br>descriptive pharmacokinetic investigation.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. The bioavailability of enalapril and its active metabolite enalaprilat in<br /><br>the different age subsets (0 to *12 months and 12 months to *6 years) of the<br /><br>paediatric study population (AUC from 0 to time of last sampling point, Cmax<br /><br>and Tmax); descriptive pharmacokinetic investigation.<br /><br>2. Markers of the renin-angiotensin-aldosterone system as exploratory<br /><br>pharmaco-dynamic investigation.<br /><br>3. Brain natriuretic peptides (BNPs).<br /><br>4. Acceptability and palatability of the novel formulation.<br /><br>5. Safety parameters including blood pressure and renal function.<br /><br>6. Echocardiography (Shortening Fraction).<br /><br>7. Rehospitalisation due to heart failure including the need for heart<br /><br>transplantation or the institution of mechanical circulatory support.<br /><br>8. Death due to worsening of the underlying disease.<br /><br>9. Pharmacodynamic and efficacy endpoints analysis to differentiate high and<br /><br>low output disease.</p><br>