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    Summary
    EudraCT Number:2016-004194-40
    Sponsor's Protocol Code Number:MYOCARDIAL-IRON
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-12-12
    Trial results View 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 number2016-004194-40
    A.3Full title of the trial
    Changes in Myocardial Iron Content Following Administration of Intravenous Iron
    Cambios en el contenido de hierro miocárdico tras la administración intravenosa de hierro
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Changes in Myocardial Iron Content Following Administration of Intravenous Iron
    Cambios en el contenido de hierro miocárdico tras la administración intravenosa de hierro
    A.4.1Sponsor's protocol code numberMYOCARDIAL-IRON
    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 SponsorInstituto de Investigación Sanitaria INCLIVA
    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 supportVIFOR PHARMA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto de Investigación Sanitaria INCLIVA
    B.5.2Functional name of contact pointMarta Peiro
    B.5.3 Address:
    B.5.3.1Street AddressAvd. Menendez Pelayo 4 acc
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46010
    B.5.3.4CountrySpain
    B.5.4Telephone number0034961973536
    B.5.5Fax number0034961973540
    B.5.6E-mailgestioncientifica@incliva.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 Ferinject 50 mg / ml solution for injection and infusion
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France SA
    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.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 placeboSolution 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
    Chronic Heart Failure
    Insuficiencia Cardiaca Crónica
    E.1.1.1Medical condition in easily understood language
    Chronic Heart Failure
    Insuficiencia Cardiaca Crónica
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10008908
    E.1.2Term Chronic heart failure
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine and quantify the changes in myocardial iron content at 7 and 30-day after the administration of intravenous ferric carboxymaltose. Such changes will be assessed by T2* CMR.
    Determinar y cuantificar los cambios en el contenido de hierro del miocardio a los 7 y 30 días después de la administración de carboximaltosa de hierro (Ferinject®) medidos mediante resonancia magnética cardiaca (RMC) en T2*.
    E.2.2Secondary objectives of the trial
    - To correlate the changes in myocardial iron content after the administration of intravenous ferric carboxymaltose with the evolution of surrogate markers of disease’s severity at 7 and 30 days.
    - Left ventricular ejection fraction
    -. Functional capacity
    -Quality of life indicators
    -Biomarkers
    - The same correlates as point 1, but stratified in subgroups:
    - Age >70 vs. ≤70 years
    -Anemic vs. non-anemic
    -Ischemic vs. non-ischemic etiology.
    - To correlate myocardial iron content and its changes with blood markers related to iron biology/deficiency at 7 and 30 days.
    - Transferrin saturation index (TSAT)
    - Ferritin
    - Soluble transferrin receptor (sTfR)
    - Hepcidin
    Correlacionar los cambios en el contenido de hierro de miocardio en RMC después de la administración de carboximaltosa de hierro
    iv con la evolución de los marcadores de severidad de la enfermedad a los 7 y 30 días:
    - Fracción de eyección del ventrículo izquierdo
    - Capacidad funcional
    - Indicadores de calidad de vida
    - Biomarcadores
    Correlacionar los cambios en el contenido de hierro de miocardio en RMC después de la administración de carboximaltosa férrica iv con la evolución de los marcadores de severidad de la enfermedad, estratificando los siguientes subgrupos:
    - Edad > 70 vs ≤ 70 años.
    - Anémicos vs no anémicos (según criterios de la OMS)
    - Etiología isquémicos vs etiología no isquémica.
    Correlacionar el contenido de hierro de miocardio en RMC y sus cambios con los marcadores sanguíneos relacionados con la biología del hierro a los 7 y 30 días.
    - Índice de saturación de transferrina (TSAT)
    - Ferritina
    - Receptor soluble de transferrina (RsTf)
    - Hepcidina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with ambulatory chronic HF
    2. Older than 18 years.
    3. Patients in NYHA class II-III on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of HF drugs during the last 2 weeks (with the exception of diuretics).
    4. Elevated natriuretic peptides levels (NT-proBNP >400 pg/ml) at the screening visit
    5. LVEF <50% documented in the last 12 months.
    6. Iron deficiency defined as: serum ferritin level <100 μg/L or ferritin level 100-299 μg/L when TSAT is less than 20%, and hemoglobin <15 g/dL (all at screening).
    7. Participant is willing and able to give informed consent for participation in the study.
    1. Pacientes con insuficiencia cardiaca crónica ambulatoria
    2. Mayor de 18 años.
    3. Pacientes en clase NYHA II-III con terapia óptima (determinado por el investigador) durante las últimas 4 semanas, sin cambios de
    dosis de la medicación para la insuficiencia cardiaca durante las últimas 2 semanas (con excepción de los diuréticos).
    4. Niveles elevados de péptidos natriuréticos (NT-proBNP> 400 pg/ml) en la visita de selección.
    5. FEVI <50% documentada en los últimos 12 meses.
    6. Deficiencia de hierro definida como: ferritina en suero <100 g/L o ferritina 100-299 mg/L cuando TSAT es menor de 20%, y la hemoglobina <15 g/dL (en el momento de selección).
    7. Participante capaz de dar su consentimiento informado para la participación en el estudio.
    E.4Principal exclusion criteria
    The participant may not enter the study if ANY of the following conditions is present:
    1. Known sensitivity to any of the products to be administered per protocol.
    2. History of acquired iron overload.
    3 Severe valve disease, or being scheduled for cardiac surgery within the next 30 days
    4 Acute myocardial infarction or acute coronary syndrome, transient ischemic attack, or stroke within the last 3 months prior to randomization.
    5. Coronary artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, and aortic; diagnostic catheters are llowed), or major surgery, including thoracic and cardiac surgery, within the last 3 months prior to randomization.
    6. Ischemic heart disease scheduled for revascularization procedures within the next 30 days.
    7. HF scheduled for cardiac resynchronization therapy within the next 30 days.
    8. Patients with active bleeding in the last 30 days.
    9. Known active infection or active malignancy.
    10. Subject at an immediate need of transfusion or hemoglobin ≥15 g/dL.
    11. Anemia due to reasons other than iron deficiency
    12. Immunosuppressive therapy or renal dialysis
    13. History of erythropoietin, intravenous iron therapy, and blood transfusion in the previous 12 weeks.
    14. Oral iron therapy at doses >100 mg/day in previous 1 week prior to randomization.
    15. Subjects with an immediate need for transfusion.
    16. Pregnant or breastfeeding women.
    17. Subject of childbearing potential who is not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
    18. Subject currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study, or subject is receiving other investigational agent(s).
    19. Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
    El paciente no podrá entrar en el estudio si presenta alguna de las siguientes condiciones:
    1. Sensibilidad conocida a cualquiera de los productos que va a administrarse por protocolo.
    2. Historia de sobrecarga de hierro adquirida.
    3. Enfermedad valvular severa, o cirugía valvular en los siguientes 30 días.
    4. Infarto agudo de miocardio o síndrome coronario agudo, ataque isquémico transitorio o accidente cerebrovascular en los últimos 3
    meses antes de la aleatorización.
    5. Bypass coronario, intervencionismo percutáneo (por ejemplo cardiaco, cerebrovascular o de aorta). No se incluyen los cateterismos diagnósticos. Cirugía mayor, incluyendo torácica y cirugía cardíaca, en los últimos 3 meses antes de la aleatorización.
    6. Cardiopatía isquémica programada para procedimiento de revascularización dentro de los 30 días siguientes.
    7. Terapia de resincronización cardiaca en los 30 días siguientes.
    8. Hemorragia activa en los últimos 30 días.
    9. Infección o malignidad activa conocida.
    10. Necesidad inmediata de transfusión o hemoglobina ≥15 g/dL.
    11. Anemia debida a motivos diferentes a la deficiencia de hierro.
    12. Tratamiento inmunosupresor o diálisis.
    13. Historial de tratamiento con eritropoyetina, hierro por vía intravenosa y transfusión de sangre en las 12 semanas anteriores.
    14. tratamiento con hierro oral a dosis> 100 mg / día en una semana anterior antes de la aleatorización.
    15. Sujetos con una necesidad inmediata de la transfusión.
    16. Mujeres embarazadas o en período de lactancia.
    17. Mujeres que intentan quedarse embarazadas y no están dispuestas a utilizar medidas anticonceptivas adecuadas durante el estudio y un máximo de 5 días después de la última dosis programada de la medicación del estudio.
    18. Participación o haber participado en otro ensayo clínico con producto sanitario, medicamentos u otro agente en investigación
    en el momento de la inclusión o 30 días antes de la inclusión.
    19. Cualquier tipo de trastorno que compromete la capacidad del sujeto para dar su consentimiento informado por escrito y / o para cumplir con los procedimientos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in myocardial iron content assessed by T2* CMR on day 7 and day 30 after drug administration.
    Cambios en el contenido de hierro de miocardio evaluados por CMR en T2 *. el día 7 y día 30 después de la administración del fármaco.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 and 30 days
    7 y 30 dias
    E.5.2Secondary end point(s)
    Effect of T2* CMR changes on day 7 and day 30 after after drug administration on:
    1. Changes in left ventricular systolic function evaluated with CMR
    2. Changes in functional capacity assessed by distance walked in 6 minutes (6MWT), and New York Heart Association (NYHA) class
    3. Quality of life assessed by The Kansas City quality of life questionnaire (KCCQ)
    4. Biomarkers: Antigen carbohydrate 125 (CA125), amino-terminal pro-brain natriuretic peptide (NT-proBNP), galectin-3, ST-2, high-sensitivity troponin (hsTnT), cystatin C, neutrophil gelatinase-associated lipocalin (NGAL), serum creatinine, urea, estimated glomerular
    filtration rate (eGFR), hemoglobin, ferritin, TSAT, sTfR and hepcidin.
    Efecto de las variaciones CMR T2 * en el día 7 y el día 30 después de después de la administración del fármaco en:
    1. Cambios en la función sistólica del ventrículo izquierdo evaluados con CMR
    2. Cambios en la capacidad funcional evaluada por la distancia recorrida en 6 minutos (6MWT), y la clase de la New York Heart Association (NYHA)
    3. Calidad de vida evaluada por la calidad de Kansas City of Life Questionnaire (KCCQ)
    4. Biomarcadores: antígeno carbohidrato 125 (CA125), pro-péptido natriurético cerebral amino-terminal (NT-proBNP), galectina-3, ST-2, sensibilidadde alta de troponina (hsTnT), cistatina C, neutrófilos lipocalina asociada a la gelatinasa (NGAL), creatinina sérica, urea, la tasa de filtración glomerular estimada(EGFR), hemoglobina, ferritina, TSAT, RsTf y hepcidina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    7 and 30 days
    7 y 30 dias
    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 No
    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 trial2
    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 concerned4
    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
    last visit of the last participant.
    última visita del último participante
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    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)
    At 30-days, patients allocated to placebo will receive intravenous ferric carboxymaltose in case of
    persistence of iron deficiency.
    A los 30 días, los pacientes asignados al placebo recibirán carboximaltosa férrica intravenosa en caso de persistencia de la deficiencia de hierro.
    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 Decision2017-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-26
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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