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    Summary
    EudraCT Number:2019-001756-19
    Sponsor's Protocol Code Number:MTP-2019-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-01-09
    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 number2019-001756-19
    A.3Full title of the trial
    MULTI-CENTER, DOUBLE-BLIND, CONTROLLED, PARALLEL AND RANDOMIZED STUDY TO COMPARE THE EFFECTIVENESS OF 0.1 ΜG / KG / MIN OF LEVOSIMENDAN VERSUS PLACEBO IN THE POSTOPERATIVE OF CARDIAC PROGRAMMED SURGERY.
    ESTUDIO MULTICÉNTRICO, DOBLE-CIEGO, CONTROLADO, PARALELO Y RANDOMIZADO
    PARA COMPARAR LA EFICACIA DE 0.1 ΜG/KG/MIN DE LEVOSIMENDÁN VERSUS PLACEBO EN EL POSTOPERATORIO DE CIRUGIA PROGRAMADA CARDIACA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Spanish Randomized Clinical Trial on Sindax
    Ensayo clínico aleatorizado español sobre Sindax
    A.4.1Sponsor's protocol code numberMTP-2019-01
    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 SponsorMaría de los Ángeles Tena Pajuelo (Investigador independiente)
    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 supportInvestigador independiente
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeon Research
    B.5.2Functional name of contact pointIrene Minguez
    B.5.3 Address:
    B.5.3.1Street AddressC/ Julia Morros s/n Edif. Usos Comunes, Local 1 Parque Tecnológico León
    B.5.3.2Town/ cityLeon
    B.5.3.3Post code24009
    B.5.3.4CountrySpain
    B.5.4Telephone number+34987 261 064
    B.5.6E-mailiminguez@leonresearch.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 SIMDAX
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameSIMDAX
    D.3.2Product code SIMDAX
    D.3.4Pharmaceutical form Concentrate 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/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients who have preoperatively severe left ventricular dysfunction (LVEF ≤ 35%) and will be scheuled for cardiac surgery on cardiopulmonary bypass.
    Pacientes programados para cirugía cardiaca electiva con circulación extracorpórea que presentan disfunción ventricular izquierda
    E.1.1.1Medical condition in easily understood language
    Patients with heart disease and a very impaired cardiac function that require a non-urgent cardiac surgery with a stopped heart surgery.
    Pacientes con enfermedad del corazon y con una función cardiaca muy deteriorada que precisan de forma no urgente una cirugia cardiaca con corazón parado.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Analyze the rate of low postoperative cardiac output syndrome (defined as the cardiac index of the postoperated patient ≤2.0 L / min / m2, or the need to implant a counterpulsate balloon / left ventricular assist device, or vasoactive inotropic scale (VIS )> 5.5) in patients with severe ventricular dysfunction who have been treated with levosimendan preoperatively versus patients treated with placebo, during the first month of surgery.
    Analizar la tasa de Síndrome de bajo gasto cardíaco postoperatorio (definido como índice cardíaco del paciente postoperado ≤2.0 L / min / m2, o la necesidad de implantar un de balón de contrapulsación / dispositivo de asistencia del ventrículo izquierdo, o escala inotrópica vasoactiva (VIS) > 5,5) en pacientes con disfunción ventricular severa que han sido tratados con levosimendan preoperatoriamente versus pacientes tratados con placebo, durante el primer mes de la cirugía.
    E.2.2Secondary objectives of the trial
    Analyze the compound rate of events one year after surgery that includes one of the following options: death from any cause, need for renal replacement therapy or dialysis and low cardiac output syndrome
    Analizar la tasa compuesta de eventos a un año de la cirugía que incluye una de las siguientes opciones: muerte por cualquier causa, necesidad de terapia de
    sustitución renal o diálisis y síndrome de bajo gasto cardía
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients 18 years of age or older.
    2. Documented ejection fraction of the left ventricle ≤ 35% measured by
    echocardiogram within 7 days prior to surgery.
    3. Patients scheduled to undergo one of the following cardiac surgery with
    extracorporeal circulation of:


    1) surgery on the aortic valve, or

    2) myocardial revascularization surgery due to ischemic heart disease or

    3) the two previous procedures combined.

    4. Patients who have signed the informed consent.
    1. Pacientes de 18 años o más.
    2. Fracción de eyección documentada del ventrículo izquierdo ≤ 35% medida por
    ecocardiograma dentro de los 7 días anteriores a la cirugía.
    3. Pacientes programados para someterse a una de las siguientes cirugia cardiaca con
    circulación extracorpórea de:


    1) cirugía sobre la válvula aórtica, o

    2) cirugía de revascularización miocárdica por cardiopatía isquémica o

    3) los dos procedimientos anteriores combinados.

    4. Pacientes que hayan firmado el consentimiento informado.
    E.4Principal exclusion criteria
    1. Previous administration of Levosimendan
    2. Emergency operation
    3. Previous or pending renal or liver transplantation.
    4. Liver cirrhosis: Child C. In the case of Child B, contact the Coordinating Center.
    5. Any degree of preoperative right ventricular failure
    6. Preoperative creatinine> 2 mg / dl
    7. Valvulopathy that is not aortic.
    8. Renal impairment with dialysis (or creatinine clearance <30ml / min).
    9. Hemodynamic instability (need for inotropics, unstable angina, acute AMI,
    use of counterpulsation balloon).
    10. Reoperated.
    11. Hypersensitivity to levosimendan or any of the excipients.
    12. Severe hypotension and tachycardia
    13. History of Torsades de Pointes.
    14. Pregnancy or Lactation.
    1. Administración anterior de Levosimendan
    2. Operación de emergencia
    3. Trasplante renal o hepático previo o pendiente.
    4. Cirrosis hepática: Child C. En caso de Child B contactar con el Centro Coordinador.
    5. Cualquier grado de fallo ventricular derecha preoperatoria
    6. Creatinina preoperatoria> 2 mg / dl
    7. Valvulopatía que no sea aórtica.
    8. Insuficiencia renal con diálisis (o aclaramiento de creatinina < 30ml/min).
    9. Inestabilidad hemodinámica (necesidad de inotrópicos, angina inestable, IAM agudo,
    uso de balón de contrapulsación).
    10. Reintervenidos.
    11. Hipersensibilidad a levosimendán o a cualquiera de los excipientes.
    12. Hipotensión grave y taquicardia
    13. Historia de Torsades de Pointes.
    14. Embarazo o Lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence of low cardiac output syndrome in the interval from surgery to the month after surgery.
    2. Composite incidence at one year of global mortality, need for dialysis and low syndrome cardiac output.
    1. Incidencia de síndrome de bajo gasto cardíaco en el intervalo desde la cirugía al mes de ésta.
    2. Incidencia compuesta al año de mortalidad global, necesidad de diálisis y síndrome de bajo
    gasto cardíaco.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The results will be evaluated at one month and at 12 months through an outpatient visit.
    Los resultados se evaluarán al mes y a los 12 meses mediante visita en consulta
    externa.
    E.5.2Secondary end point(s)
    Intensive medicine unit stay, total post-surgical stay, hospital cardiac mortality, need for ventricular assistance or counterpulsation balloon and need for dialysis.
    Estancia en unidad de medicina intensiva, estancia total postquirúrgica, mortalidad cardiaca hospitalaria, necesidad de asistencia ventricular o balón de contrapulsación y necesidad de diálisis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The results will be evaluated at one month and at 12 months through an outpatient visit.
    Los resultados se evaluarán al mes y a los 12 meses mediante visita en consulta
    externa.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    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
    LPLV
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state300
    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)
    TBD
    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 Decision2019-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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