Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of levosimendan versus conventional intensified inotropic treatment, in critical children with severe acute heart failure which persists despite of having received conventional inotropic treatment.

Official Title
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Phase II Study to Evaluate the Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children

Conditions
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Acute Heart Failure

Intervention / Treatment
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* Drug: Levosimendan
* Drug: Conventional intensified inotropic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who give written consent to participate in the study and for the transfer of material for cellular and molecular studies. Understand the purpose of the study and to be available to perform the procedures written in the protocol. Any child of 1 day old to 18 years old, admitted to the Paediatric Intensive Care Unit due to severe acute heart failure of any etiology. Exclusion Criteria: All patients who express their wish of not to participate in the protocol have hypertrophic or restrictive cardiomyopathy have aortic Stenosis have a known allergy to any drug used in the study it is not possible to prescribe the study medication because it is contraindicated according to the Summary of the Product Characteristic or according to the criteria of the physician responsible for patient are pregnant

Ages Eligible for Study
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Minimum Age: 24 Hours
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levosimendan<br> | Drug: Levosimendan<br>* Levosimendan 2.5 mg / ml ampoules. The drug will be administrated in continuous intravenous perfusion in a single dose of 0.1 - 0.2 micrograms/ kg / min for 24 hours.<br>|
| Active Comparator: Conventional intensified inotropic treatment<br> | Drug: Conventional intensified inotropic treatment<br>* Increasing the dose and / or the number of inotropes (dopamine and / or dobutamine and / or milrinone and / or adrenaline)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic improvement at 24 hours | To evaluate the efficacy of levosimendan in the treatment of severe acute heart failure in children in critical conditions comparing the proportion of patients with hemodynamic improvement at 24 hours between the group who received levosimendan as rescue therapy (experimental treatment) versus the one who received intensified conventional inotropic treatment (control treatment) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in cardiac output | To compare the improvement in cardiac output induced by levosimendan in the treatment of severe acute heart failure in critical children versus the intensified conventional inotropic treatment, at 24 and 48h | 24 and 48 hours | 
| Improvement in the neurohormonal profile | To compare the improvement in the neurohormonal profile (assessed as a reduction of BNP) induced by levosimendan in the treatment of severe acute heart failure in critical children versus the intensified conventional inotropic treatment, at 24 and 48h. | 24 and 48 hours | 
| Number of days of hospital stay in paediatric intensive care unit | To compare the number of days of hospital stay in paediatric intensive care unit and the number of days on mechanical ventilation, at 30 days. | 30 days | 
| Safety | To assess the safety of the use of levosimendan in the treatment of severe acute heart failure in children in critical conditions, at 30 days. | 30 days | 
| Survival | Survival, at 30 days | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute heart failure, Children, Levosimendan, Inotropic treatment