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

Acute Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01301313
• Other study ID #: LEVOPED1
• Secondary ID: 2009-017827-24
• Status: Terminated
• Phase: Phase 2
• First received: February 22, 2011
• Last updated: January 30, 2013
• Start date: February 2011
• Est. completion date: February 2012

Study information

• Verified date: January 2013
• Source: Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 116
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Drug:
• Levosimendan
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.
• Conventional intensified inotropic treatment
Increasing the dose and / or the number of inotropes (dopamine and / or dobutamine and / or milrinone and / or adrenaline)

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Santiago de Compostela	A Coruña
Spain	Hospital Juan Canalejo	A Coruña
Spain	Hospital San Joan de Deu	Barcelona
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Donosti	Donostia	San Sebastian
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Infantil La Paz	Madrid
Spain	Hospital Universitario Doce de Octubre	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario Carlos Haya	Malaga
Spain	Hospital Virgen de la Arrixaca	Murcia
Spain	Hospital Clínico Universitario Son Dureta	Palma de Mallorca
Spain	Complejo Hospitalario Universitario de Salamanca	Salamanca
Spain	Hospital Virgen de la Salud	Toledo
Spain	Hospital Clínico de Valencia	Valencia
Spain	Hospital La Fe	Valencia
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Spain	Hospital de Cruces	Vizcaya
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Jose Luis Vazquez Martinez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Survival	Survival, at 30 days	30 days	No