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

Jose Luis Vazquez Martinez

Status and phase: Terminated; Phase 2

Conditions: Acute Heart Failure

Treatments: Drug: Conventional intensified inotropic treatment; Drug: Levosimendan

Study type: Interventional

Funder types: Other

Identifiers

NCT01301313

2009-017827-24 (EudraCT Number)

LEVOPED1

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 24 hours to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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116 participants in 2 patient groups

Levosimendan

Experimental group

Treatment:

Drug: Levosimendan

Conventional intensified inotropic treatment

Active Comparator group

Treatment:

Drug: Conventional intensified inotropic treatment