How does the body of children deal with Levosimendan, a drug which strengthens the heart.
Phase 1
- Conditions
- heart failureMedDRA version: 20.0Level: LLTClassification code 10000803Term: Acute heart failureSystem Organ Class: 100000011689Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-000588-26-FI
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
All children < 16 years of age receiving levosimendan as part of their treatment for acute heart failure
Are the trial subjects under 18? yes
Number of subjects for this age range: 36
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
no informed consent
no sampling line at the start of the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to describe the pharmacokinetics of levosimendan in children with acute heart failure;Secondary Objective: 1. Indicators of heart failure: Heart rate, blood pressure, lactate, venous<br>haemoglobin-oxygen saturation, pro-BNP, echocardiography (shortening<br>fraction, speckles), and inotrope score. Serious advert event: atrial fibrillation, ventricular arrhythmia. Acetylation status;Primary end point(s): to describe the pharmacokinetic profile of levosimendan and its metabolites;Timepoint(s) of evaluation of this end point: Each child will be followed for twelve days following the infusion of levosimendan
- Secondary Outcome Measures
Name Time Method