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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Jose Luis Vazquez Martinez, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT01301313
First received: February 22, 2011
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Acute Heart Failure
Drug: Levosimendan
Drug: Conventional intensified inotropic treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study to Evaluate the Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Ramon y Cajal:

Primary Outcome Measures:
  • Hemodynamic improvement at 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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:
  • Improvement in cardiac output [ Time Frame: 24 and 48 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 and 48 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Survival, at 30 days


Enrollment: 116
Study Start Date: February 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levosimendan 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.
Active Comparator: Conventional intensified inotropic treatment Drug: Conventional intensified inotropic treatment
Increasing the dose and / or the number of inotropes (dopamine and / or dobutamine and / or milrinone and / or adrenaline)

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301313

Locations
Spain
Hospital Donosti
Donostia, San Sebastian, Spain
Hospital Juan Canalejo
A Coruña, Spain
Hospital Clínico Universitario de Santiago de Compostela
A Coruña, Spain
Hospital San Joan de Deu
Barcelona, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Universitario Doce de Octubre
Madrid, Spain
Hospital Infantil La Paz
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital General Universitario Gregorio Marañón
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 La Fe
Valencia, Spain
Hospital Clínico de Valencia
Valencia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Hospital de Cruces
Vizcaya, Spain
Hospital Miguel Servet
Zaragoza, Spain
Sponsors and Collaborators
Jose Luis Vazquez Martinez
Investigators
Principal Investigator: Jose Luis Vazquez MArtinez, MD Hospital Universitario Ramón y Cajal. Madrid
  More Information

No publications provided

Responsible Party: Jose Luis Vazquez Martinez, Doctor, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT01301313     History of Changes
Other Study ID Numbers: LEVOPED1, 2009-017827-24
Study First Received: February 22, 2011
Last Updated: January 30, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitario Ramon y Cajal:
Acute heart failure
Children
Levosimendan
Inotropic treatment

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Simendan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014