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    Summary
    EudraCT Number:2014-001461-27
    Sponsor's Protocol Code Number:FIM-BGC-2014-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-10-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-001461-27
    A.3Full title of the trial
    Evaluation of the effect of organic preservation with the use of levosimendan after cardiac surgery in patients with low output syndrom compared with dobutamine.
    Evaluación del efecto de preservación orgánica con el uso del levosimendán postoperatorio de cirugía cardiaca, en los pacientes con síndorme de bajo gasto, en comparación con la dobutamina.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the organic effect of levosimendan after surgery in patients with low output syndrom.
    Evaluación del efecto orgánico del levosimendán tras cirugía cardiaca en pacientes con síndrome de bajo gasto.
    A.3.2Name or abbreviated title of the trial where available
    FIM-BGC-2014-01
    FIM-BGC-2014-01
    A.4.1Sponsor's protocol code numberFIM-BGC-2014-01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFIMABIS
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFIMABIS, main investigator
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFIMABIS
    B.5.2Functional name of contact pointClinical Trials Unit
    B.5.3 Address:
    B.5.3.1Street AddressAvda Carlos Haya, s/n
    B.5.3.2Town/ cityMálaga
    B.5.3.3Post code29010
    B.5.3.4CountrySpain
    B.5.4Telephone number34951291977
    B.5.6E-mailgloria.luque.exts@juntadeandalucia.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name LEVOSIMENDAN
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLEVOSIMENDAN
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVOSIMENDAN
    D.3.9.1CAS number 141505-33-1
    D.3.9.4EV Substance CodeSUB08493MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name DOBUTAMINA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDOBUTAMINA
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOBUTAMINE
    D.3.9.1CAS number 34368-04-2
    D.3.9.4EV Substance CodeSUB06343MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Low cardiac output syndrome
    Síndorme de bajo gasto cardiaco
    E.1.1.1Medical condition in easily understood language
    Low cardiac output syndrome
    Síndorme de bajo gasto cardiaco
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10024899
    E.1.2Term Low cardiac output syndrome
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effects of postoperative administration of levosimendan in patients with low output syndrome after cardiac surgery, renal and neurological level, measured by prognostic marker N-GAL and S 100 protein, compared with the rest of inotropic therapies and the initial situation of the patient.
    Evaluar los efectos de la administración postoperatoria de levosimendán en pacientes con síndrome de bajo gasto tras cirugía cardiaca a nivel renal y neurológico, medido a través del marcador pronóstico N-GAL y la proteína S 100, en comparación con el resto de terapias inotrópicas y con la situación inicial del paciente.
    E.2.2Secondary objectives of the trial
    To assess the effects on the various hemodynamic parameters (cardiac index and mixed venous saturation), biochemical marker of cardiac dysfunction (Nt-proBNP) and cardioprotective (troponin T) and the use of vasoactive drugs.
    ? Evaluate the relationship between therapy and renal function parameters.
    ? Assess whether there are differences in the incidence of arrhythmias in each of the groups.
    ? Evaluar los efectos en los distintos parámetros hemodinámicos (índice cardiaco y saturación venosa mixta), parámetro bioquímico de disfunción cardiaca (Nt-ProBNP) y de cardioprotección (troponina T) y del uso de fármacos vasoactivos.
    ? Evaluar relación de la duración de la terapia inotrópica con los parámetros de función renal
    ? Evaluar si existen diferencias en la incidencia de arritmias en cada uno de los grupos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients where inotropic support is considered appropiate because of a diagnosis of low cardiac output, cardiac index, which remains below 2 L/min/m2 with POP greater than 15 mmHg and / or less than 65% satVO2) syndrome.
    Pacientes donde se considere apropiado un soporte inotrópico por. diagnóstico de síndrome de bajo gasto cardiaco, donde el índice cardiaco permanece por debajo de 2 l/min/m2 con una POP mayor de 15 mmHg y/o satVO2 menor del 65%).
    E.4Principal exclusion criteria
    . History of adverse reaction to levosimendan.
    ? Pregnant
    ? Combined surgery (eg valve repair or carotid surgery).
    ? Patients in situations of hemodynamic instability.
    ? preoperative renal dysfunction, estimated by the rate of preoperative GFR (creatinine clearance <50ml/min).
    ? Hypersensitivity to levosimendan or any of the excipients.
    ? significant mechanical obstructions affecting ventricular filling or emptying, or both.
    ? History of Torsades de Pointes.
    ? Status of cardiogenic shock (lactate> 4 mmol / L)
    ? Historia de reacción adversa a levosimendán.
    ? Embarazadas
    ? Cirugía combinada (ejemplo reparación valvular o de cirugía carotidea).
    ? Pacientes en situación de inestabilidad hemodinámica.
    ? Disfunción renal preoperatoria, estimada a través de la tasa de FG preoperatoria (aclaramiento de creatinina < 50ml/min).
    ? Hipersensibilidad a levosimendán o a cualquiera de los excipientes.
    ? Obstrucciones mecánicas significativas que afecten al llenado o al vaciado ventricular o a ambos.
    ? Historia de Torsade de Pointes.
    ? Situación de shock cardiogénico (lactato>4 mmol/L)
    E.5 End points
    E.5.1Primary end point(s)
    To assess the effects of postoperative administration of levosimendan in patients with low output syndrome after cardiac surgery, renal and neurological level, measured by prognostic marker N-GAL and S 100 protein, compared with the rest of inotropic therapies and the initial situation of the patient.
    Evaluar los efectos de la administración postoperatoria de levosimendán en pacientes con síndrome de bajo gasto tras cirugía cardiaca a nivel renal y neurológico, medido a través del marcador pronóstico N-GAL y la proteína S 100, en comparación con el resto de terapias inotrópicas y con la situación inicial del paciente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monthly
    Mensualmente
    E.5.2Secondary end point(s)
    To assess the effects on the various hemodynamic parameters (cardiac index and mixed venous saturation), biochemical marker of cardiac dysfunction (Nt-proBNP) and cardioprotective (troponin T) and the use of vasoactive drugs.
    ? Evaluate the relationship between therapy and renal function parameters.
    ? Assess whether there are differences in the incidence of arrhythmias in each of the groups.
    Evaluar los efectos en los distintos parámetros hemodinámicos (índice cardiaco y saturación venosa mixta), parámetro bioquímico de disfunción cardiaca (Nt-ProBNP) y de cardioprotección (troponina T) y del uso de fármacos vasoactivos.
    ? Evaluar relación de la duración de la terapia inotrópica con los parámetros de función renal
    ? Evaluar si existen diferencias en la incidencia de arritmias en cada uno de los grupos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monthly
    Mensualmente
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-18
    P. End of Trial
    P.End of Trial StatusOngoing
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