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    Summary
    EudraCT Number:2011-001726-14
    Sponsor's Protocol Code Number:1/2011
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-28
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-001726-14
    A.3Full title of the trial
    Supplementetion with vitamin D in patients with chronic heart failure and hypovitaminosis D
    Effetti della supplementazione di vitamina D in pazienti con ipovitaminosi D e insufficienza cardiaca cronica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the effects of chronic treatment with vitamin D in patients with chronic heart failure and low level of vitamin D
    Valutazione degli effetti di un trattamento cronico con vitamina D nei pazienti con scompenso cardiaco cronico e documentata carenza di vitamina D
    A.4.1Sponsor's protocol code number1/2011
    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 SponsorAUSL DI MODENA
    B.1.3.4CountryItaly
    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 supportABIOGEN PHARMA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMEDICINA CARDIOVASCOLARE
    B.5.2Functional name of contact pointNUOVO OSPEDALE CIVILE DI MODENA
    B.5.3 Address:
    B.5.3.1Street AddressVIA GIARDINI 1355
    B.5.3.2Town/ cityBAGGIOVARA - MODENA
    B.5.3.3Post code41126
    B.5.3.4CountryItaly
    B.5.4Telephone number0593961100
    B.5.6E-mailf.turrini@ausl.mo.it
    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 DIBASE*OS SOLUZ 2,5ML 25000UI
    D.2.1.1.2Name of the Marketing Authorisation holderABIOGEN PHARMA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Oral drops
    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 INNvitamina D3
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 placeboOral drops
    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
    CHRONIC HEART FAILURE (NYHA CLASS II-III) VITAMIN D DEFICIT
    INSUFFICIENZA CARDIACA CRONICA (CLASSE II-III NYHA) e IPOVITAMINOSI D
    E.1.1.1Medical condition in easily understood language
    CHRONIC HEART FAILURE and VITAMIN D DEFICIT
    Scompenso cardiaco cronico in fase di stabilità e carenza di vitamina D
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10006974
    E.1.2Term Calcium metabolism disorder
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10063083
    E.1.2Term Chronic left ventricular failure
    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
    Verify if cholecalciferol supplementation in heart failure patients with proved vitamin D deficiency could improve their performance at six minute walking test
    Verificare se la supplementazione con vitamina D nella forma di colecalciforolo in persone con documentata carenza e concomitante insufficienza cardiaca cronica migliori la performance al test deli 6 minuti di cammino
    E.2.2Secondary objectives of the trial
    Verify if cholecalciferol supplementation in heart failure patients with proved vitamin D deficiency could improve their echocardiographic features of ventricular remodeling
    Verificare se la supplementazione con vitamina D nella forma di colecalciforolo in persone con documentata carenza e concomitante insufficienza cardiaca cronica migliori i parametri ecocardiografici di rimodellamento cardiaco
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Chronic heart failure; NYHA class II-III - stable in the last three months 2)Age greater than 60 year old 3)Plasma 25(OH) vitamin D less than 30 ng/ml
    1)Insufficienza cardiaca cronica classe NYHA II-III - stabilità clinica negliultimi tre mesi 2) Età maggiore di 60 anni 3) (OH)vitamina D plasmatica inferiore a 30 ng/ml
    E.4Principal exclusion criteria
    1) Chronic use of anticonvulsivants, steroids, digitalis, thiazides 2)glomerular filtration rate lower than30 ml/min/1.73m2 (according to MDRD formula) 3)nefrolithiasia, sarcoidosis and hypercalcemia 4)Coronary acute syndrome or stroke in the previous three months 5) Cancer with prognosis lower than three years 6) Vertebral osteoporotic compression fractures or frequent falls
    1) Uso cronico di anticonvulsivanti, steroidi, digitale, tiazidici, tiazidici 2)filtrato glomerulare inferiore a 30 ml/min/1.73m2 (secondo la formula MDRD) 3)storia di nefrolitiasi, sarcoidosi e ipercalcemia 4) Sindrome coronarica acuta o stroke negli ultimi tre mesi 5) Neoplasia attiva con prognosi inferiore a 3 anni 6) fratture vertebrali su base osteoporotica o frequenti cadute a terra
    E.5 End points
    E.5.1Primary end point(s)
    70 metres improvement in walked distance during six minute walking test
    Miglioramento di 70 metri nella distanza percorsa al test dei 6 minuti di cammino
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before treatment and after six motnhs of treatment
    Prima del trattamento e al termine di sei mesi di trattamento
    E.5.2Secondary end point(s)
    Improvement in ventricular remodeling as measured by some echocardiography parameters (left ventricular volumes, sphericity index, myocardial mass)
    Miglioramento dei parametri di rimodellamento cardiaco rilevati con ecocardiografia (volume ventricolare sinistro, indice di sfericità, massa miocardica)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Before treatment and after six motnhs of treatment
    Prima del trattamento e al termine di sei mesi di trattamento
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    After the completion of treatment with cholecalciferol patients will undergo the following examinations: 1) clinical examination 2) six minute walking test 3) echocardiogram 4) serum 25 OH vitamin D 4) serum Calcium, creatinin
    Al termine del trattamento con colecalciferolo i pazienti verranno sottoposti a visita clinica test del cammino dei sei minuti ecocardiogramma dosaggio vitamina D plasmatica dosaggio calcemia, creatininemia
    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 Decision2011-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
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