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    Summary
    EudraCT Number:2014-004512-11
    Sponsor's Protocol Code Number:FJD-VITDAMI-14-01
    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:2015-04-27
    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 number2014-004512-11
    A.3Full title of the trial
    Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of vitamin D on ventricular remodeling in patients with acute myocardial infarction: Test VITDAMI (Vitamin D in Acute Myocardial Infarction)
    Ensayo clínico multicéntrico, aleatorizado, doble ciego, controlado con placebo, para evaluar el efecto de la vitamina D sobre el remodelado ventricular en pacientes con Infarto Agudo de Miocardio: Ensayo VITDAMI (Vitamin D in Acute Myocardial Infarction)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the efficacy of vitamin D on ventricular remodeling in patients with acute myocardial infarction
    Ensayo clínico para evaluar la eficacia de la vitamina D sobre el remodelado ventricular en pacientes con infarto agudo de miocardio
    A.3.2Name or abbreviated title of the trial where available
    VITDAMI Clinical Trial (Vitamin D in Acute Myocardial Infarction)
    Ensayo VITDAMI
    A.4.1Sponsor's protocol code numberFJD-VITDAMI-14-01
    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 SponsorINSTITUTO DE INVESTIGACION SANITARIA FJD
    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 supportinstituto salud Carlos III
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportsociedad española de cardiología
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad de Investigación Clínica
    B.5.2Functional name of contact pointLucía Llanos Jimenez
    B.5.3 Address:
    B.5.3.1Street AddressUnidad de Investigación Clínica, avenida reyes católicos 2,
    B.5.3.2Town/ citymadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number+349155048003144
    B.5.5Fax number+34915505353
    B.5.6E-maillucia.llanos@fjd.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 No
    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 nameCalcifediol
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCALCIFEDIOL
    D.3.9.1CAS number 63283-36-3
    D.3.9.4EV Substance CodeSUB06045MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.266
    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 placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute myocardial infarction with ST segment elevation anterior
    Infarto agudo de miocardio con elevación de segmento ST de localización anterior
    E.1.1.1Medical condition in easily understood language
    Acute myocardial infarction with ST segment elevation anterior
    Infarto agudo de miocardio con elevación de segmento ST de localización anterior
    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
    To assess the effect of vitamin D3 on ventricular remodeling in patients with anterior STEMI.
    Valorar el efecto de la vitamina D3 sobre el remodelado ventricular en pacientes con IAMCEST anterior.
    E.2.2Secondary objectives of the trial
    A. Assess the effect of vitamin D on systolic and diastolic function in patients with anterior STEMI.
    B. Study in patients with anterior STEMI, the effect of vitamin D on:
    ? -The endothelial function (only in University Hospital FJD).
    ? -Levels of prognostic biomarkers: C-reactive protein high sensitivity (hsCRP), N-terminal pro-peptide (NT-proBNP), galectin-3, MCP-1 (monocyte chemoattractant protein-1) and brain natriuretic lipids.
    ? -The calcidiol levels, FGF-23, klotho, PTH and P in blood.

    C. Analyze whether there are differences in the above objectives among patients with plasma levels of FGF-23 and Klotho levels above and below the median, and in subgroups of patients with levels of calcidiol (metabolite of vitamin D) ?15 , 00 ng / ml, from 15.01 to 30.00 ng / mL, from 30.01 to 55.00 ng / ml and> 55.00 ng / ml.
    D. To evaluate the safety and tolerability of the preparation.
    A. Valorar el efecto de los suplementos de vitamina D sobre la función sistólica y diastólica, en pacientes con IAMCEST anterior.
    B. Estudiar, en pacientes con IAMCEST anterior, el efecto de los suplementos de vitamina D sobre:
    -La función endotelial (únicamente en Hospital Universitario FJD).
    -Niveles de biomarcadores pronósticos: Proteína C reactiva de alta sensibilidad (PCRhs), propéptido natriurético cerebral N-terminal (NT-proBNP), galectina-3, MCP-1 (monocyte chemoattractant protein-1) y lípidos.
    -Los niveles de calcidiol, FGF-23, klotho, PTH y P en sangre.

    C. Analizar si hay diferencias en los objetivos anteriores entre los pacientes que tengan niveles plasmáticos de FGF-23 y niveles de Klotho por encima y debajo de la mediana, y en subgrupos de pacientes con niveles de calcidiol (metabolito de vitamina D) ?15,00 ng/ml, 15,01-30,00 ng/ml, 30,01-55,00 ng/ml y >55,00 ng/ml.
    D. Evaluar la seguridad y tolerabilidad del preparado.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age between 40 and 85 years.
    2. Be ready to be discharged after STEMI previous location which is complete revascularization and defined as suggestive symptoms such as chest tightness, in the arms or jaw, or simply supported as sweating, nausea, vomiting and malaise bad defined longer than 20 minutes with ST-segment elevation in the ECG of 0.2 mV in ?2 contiguous precordial leads unresponsive to nitroglycerin followed Troponin I> 0.12 with a standard curve.
    3. Acceptance and signing the consent for the study after receiving adequate information.
    1.Edad ≥ 40 años y máxima de 85 años.
    2.Estar listos para ser dados de alta tras un IAMCEST de localización anterior al que se haya completado la revascularización y definido como: síntomas sugestivos como opresión torácica, en brazos o mandíbula, o simplemente compatibles como sudoración, náuseas, vómitos o malestar general mal definido de duración mayor de 20 minutos junto con ascenso de segmento ST en el ECG de 0,2 mV en ≥2 derivaciones precordiales contiguas sin respuesta a nitroglicerina seguido de Troponina I>0,12 con curva típica.
    3.Aceptación y firma del consentimiento para el estudio tras haber recibido la información adecuada.
    E.4Principal exclusion criteria
    11. Death during the index event
    2. Age younger than 40 or older than 85 years
    3. Complications prolong their stay more than 7 days in the index event.
    4. Infarct-s-s prior infarction.
    5. Disease limiting survival
    6. Systemic inflammatory disease or autoimmune
    7. concomitant restrictive cardiomyopathy, dilated or hypertrophic.
    8. severe ventricular hypertrophy of any etiology defined as ?17 mm wall thickness ?16 mm in men and women
    9. renal glomerular filtration lower estimate of 45 ml / min / 1.73 m2 by the CKD-EPI equation (Chronic Kidney Disease Epidemiology Collaboration)
    10. The need for heart transplantation
    11. ejection fraction less than 30%
    12. Failure to perform the desirable revascularization
    13. Revascularization pending at the time of discharge
    14. valvular prosthesis
    15. Aortic stenosis with average gradient> 25 mm Hg (Doppler) and any other valve stenosis.
    16. moderate or severe valvular insufficiency at any level
    17. Hypersensitivity or intolerance vitamin D supplement to employ or to any of the excipients.
    18. Indication of treatment with vitamin D and / or calcium supplements or patient decision making these compounds in the absence of clinical indication.
    19. Concomitant therapy with drugs that could interfere with calcifediol pK-pD.
    20. Concomitant diseases that could interfere with calcifediol pK-pD
    serum
    21. Calcium> 10.5 mg / dl, history of hypercalciuria or calcium stones
    22. Contraindications to MRI: Claustrophobia, pacemaker, defibrillator and / or resynchronization, or are anticipated to need during the study.
    23. Inability to follow.
    24. Difficulty to meet the study treatment as determined by your doctor
    25. Patient refusal to participate and signed informed consent.
    26. Pregnancy or breast-feeding state.
    1. Fallecimiento durante el evento índice
    2. Edad menor de 40 o mayor de 85 años
    3. Complicaciones que prolonguen su estancia más de 7 días en evento índice.
    4. Infarto-s de miocardio previo-s.
    5. Enfermedad que limite la supervivencia
    6. Enfermedad sistémica inflamatoria o autoinmune
    7. Miocardiopatía concomitante restrictiva, dilatada o hipertrófica.
    8. Hipertrofia ventricular severa de cualquier etiología definida como espesor parietal ≥17 mm en hombres y ≥16 mm en mujeres
    9. Filtrado glomerular renal estimado menor de 45 ml/min/1,73 m2 por la ecuación CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
    10. Necesidad de trasplante cardiaco
    11. Fracción de eyección menor del 30%
    12. Imposibilidad de realizar la revascularización deseable
    13. Revascularización pendiente en el momento del alta
    14. Prótesis valvular
    15. Estenosis aórtica con Gradiente medio>25 mm Hg (Doppler) y cualquier estenosis de otras válvulas.
    16. Insuficiencia valvular moderada o severa a cualquier nivel
    17. Hipersensibilidad o Intolerancia al suplemento de vitamina D a emplear o a alguno de sus excipientes.
    18. Indicación de tratamiento con vitamina D y/o suplementos de calcio o decisión del paciente de tomar estos compuestos en ausencia de indicación clínica.
    19. Tratamiento actual con fármacos que puedan interferir en los fenómenos de absorción, distribución, metabolismo o excreción de la vitamina D:
    a. Antiepilépticos como Fenitoína, Fenobarbital o Primidona, así como otros inductores enzimáticos
    b. Colestiramina, colestipol u orlistat
    c. Laxantes tipo Parafina y aceite mineral.
    d. Digitálicos
    e. Sales de Magnesio
    f. Verapamilo
    g. Corticosteroides

    20. Patologías que puedan interferir en la farmacocinética o en la farmacodinámica de la vitamina D:
    a. Insuficiencia Hepática
    b. Enfermedad Inflamatoria Intestinal
    c. Sarcoidosis, Tuberculosis u otras enfermedades granulomatosas

    21. Calcemia > 10,5 mg/dl, antecedentes de hipercalciuria o litiasis cálcica
    22. Contraindicaciones para Resonancia Magnética: Claustrofobia, portador de marcapasos, desfibriladores y/o resincronizadores, o se prevea que van a necesitarlos durante el estudio.
    23. Imposibilidad de seguimiento.
    24. Dificultad para cumplir el tratamiento del estudio a juicio de su médico.
    25. Negativa del paciente a participar y firmar el consentimiento informado.
    26. Mujeres embarazadas o en período de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Necrosis-fibrosis and myocardial remodeling in Cardiac Magnetic Resonance after a year of treatment, measured as:
    ? ejection fraction, assessed as a percentage of diastolic intraventricular blood volume ejected in systole (100x [volume diastolic-systolic volume] / diastolic volume)
    ? Left ventricular end-diastolic volume
    ? Left ventricular end-systolic volume
    ? Myocardial risk, defined as the area of edema.
    ? size of the infarcted area, defined as LGE (STIR signs of high intensity).
    ? salvaged myocardium, defined as the difference between the myocardium at risk and infarct zone.
    The last three variables are measured as a percentage of the volume of total left ventricular myocardium. In addition, the necrotic myocardium be expressed in grams. All results are given in absolute numbers and corrected for body surface area.
    Necrosis-fibrosis y remodelado miocárdico en Resonancia Magnética Cardiaca tras un año de tratamiento, medidos como:
    ? Fracción de eyección, valorada como porcentaje de volumen telediastólico sanguíneo intraventricular expulsado en sístole (100x [volumen telediastólico-volumen telesistólico]/volumen telediastólico)
    ? Volumen telediastólico ventricular izquierdo
    ? Volumen telesistólico ventricular izquierdo
    ? Miocardio en riesgo, definido como la zona de edema.
    ? tamaño de la zona infartada, definida como captación tardía de gadolinio (señales STIR de alta intensidad).
    ? miocardio salvado, definido como la diferencia entre miocardio en riesgo y zona infartada.
    Las tres últimas variables se medirán como porcentaje del volumen del miocardio ventricular izquierdo total. Además, el miocardio necrosado se expresará en gramos. Todos los resultados se darán en números absolutos y se corregirán para la superficie corporal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    one year
    un año
    E.5.2Secondary end point(s)
    Data Echocardiography ventricular diameters and thicknesses, changes in contractility, ejection fraction (assessed as a percentage of intraventricular blood-diastolic volume that is ejected him systole (100 x [volume diastolic-systolic volume] / diastolic volume), time deceleration peaks E and A waves, E / A ratio, isovolumic relaxation time (pulsed Doppler) waves E 'and A' (tissue Doppler).
    ? Serum calcidiol, FGF-23, and P in plasma PTH to see the effect of vitamin D supplementation on mineral metabolism.
    ? Serum NT-proBNP, MCP-1, galectin-3 and hsCRP.
    ? Lipid Levels: Total cholesterol, LDL, HDL, triglycerides and non-HDL cholesterol.
    ? Endothelial Function: Degree of flow-mediated vasodilation.
    Adverse events % and description
    % Treatment Compliance
    ? Datos de Ecocardiografía: diámetros y espesores ventriculares, alteraciones de la contractilidad, fracción de eyección (valorada como porcentaje del volumen telediastólico sanguíneo intraventricular que es expulsado en le sístole (100 x [volumen telediastólico-volumen telesistólico]/ volumen telediastólico), tiempo de deceleración, picos de las ondas E y A, cociente E/A, tiempo de relajación isovolumétrica (Doppler pulsado), ondas E' y A' (Doppler tisular).
    ? Niveles plasmáticos de calcidiol, FGF-23, PTH y P en plasma para ver el efecto de la suplementación de vitamina D sobre el metabolismo mineral.
    ? Niveles plasmáticos de NT-proBNP, MCP-1, galectina-3 y hsPCR.
    ? Niveles lipídicos: Colesterol total, LDL, HDL, triglicéridos y colesterol no-HDL.
    ? Función Endotelial: Grado de vasodilatación mediada por el flujo.
    • % y descripción de Acontecimientos Adversos.
    • % de adherencia al tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    one year
    un año
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 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
    end of one year of treatment
    al fin del año de tratamiento
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 144
    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 state144
    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)
    usual care
    según práctica clínica habitual
    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 Decision2015-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-04
    P. End of Trial
    P.End of Trial StatusOngoing
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