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

Phase 2

Terminated

• Conditions: Acute Heart Failure
• Interventions: Drug: Levosimendan; Drug: Conventional intensified inotropic treatment

• Registration Number: NCT01301313
• Lead Sponsor: Jose Luis Vazquez Martinez

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-22
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-23
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-30
• Last Update Posted: 2013-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 116

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levosimendan	Levosimendan	-
Conventional intensified inotropic treatment	Conventional intensified inotropic treatment	-

Primary Outcome Measures

Name	Time	Method
Hemodynamic improvement at 24 hours	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)

Secondary Outcome Measures

Name	Time	Method
Improvement in cardiac output	24 and 48 hours	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
Improvement in the neurohormonal profile	24 and 48 hours	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.
Number of days of hospital stay in paediatric intensive care unit	30 days	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.
Safety	30 days	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.
Survival	30 days	Survival, at 30 days

Trial Locations

Locations (19)

Hospital Donosti; 🇪🇸 Donostia, San Sebastian, Spain

Hospital Clínico Universitario de Santiago de Compostela; 🇪🇸 A Coruña, Spain

Hospital Universitario Ramon y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario Carlos Haya; 🇪🇸 Malaga, Spain

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Juan Canalejo; 🇪🇸 A Coruña, Spain

Hospital San Joan de Deu; 🇪🇸 Barcelona, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Infantil La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Doce de Octubre; 🇪🇸 Madrid, Spain

Hospital de Cruces; 🇪🇸 Vizcaya, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Clínico Universitario Son Dureta; 🇪🇸 Palma de Mallorca, Spain

Complejo Hospitalario Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Clínico de Valencia; 🇪🇸 Valencia, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain