Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2022-004186-21
    Sponsor's Protocol Code Number:VICTORID_01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-01-30
    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 number2022-004186-21
    A.3Full title of the trial
    Beneficial effects of vitamin D combined with oral iron supplementation in patients with chronic heart failure and iron deficiency (VICTORID-HF TRIAL)
    Effetti dell'utilizzo della vitamina D in associazione alla supplementazione orale di ferro sucrosomiale nei pazienti con scompenso cardiaco cronico e carenza marziale (VICTORID-HF TRIAL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Beneficial effects of vitamin D combined with oral iron supplementation in patients with chronic heart failure and iron deficiency (VICTORID-HF TRIAL)
    Effetti dell'utilizzo della vitamina D in associazione alla supplementazione orale di ferro sucrosomiale nei pazienti con scompenso cardiaco cronico e carenza marziale
    A.3.2Name or abbreviated title of the trial where available
    VICTORID-HF
    VICTORID-HF
    A.4.1Sponsor's protocol code numberVICTORID_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 SponsorDipartimento di Medicina-DIMED, università di Padova
    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 supportPharmaNutra Spa
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDipartimento di Medicina - UNIPD
    B.5.2Functional name of contact pointUfficio Ricerca e Terza Missione
    B.5.3 Address:
    B.5.3.1Street Addressvia Giustiniani, 2
    B.5.3.2Town/ cityPadova
    B.5.3.3Post code35128
    B.5.3.4CountryItaly
    B.5.4Telephone number0498211245
    B.5.6E-mailricerca.dimed@unipd.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 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 nameUltraD3
    D.3.2Product code [UltraD3]
    D.3.4Pharmaceutical form
    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 D
    D.3.9.1CAS number 67-97-0
    D.3.9.2Current sponsor code002_D
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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 nameSIDERAL FORTE
    D.3.2Product code [SIDERAL FORTE]
    D.3.4Pharmaceutical form Gastro-resistant capsule
    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 INNpirofosfato ferrico
    D.3.9.1CAS number 10058-44-3
    D.3.9.2Current sponsor code003_F
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 3
    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 Ferinject
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameFerinject
    D.3.2Product code [Ferinject]
    D.3.4Pharmaceutical form Solution for injection
    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 INNcarbossimaltosio ferrico
    D.3.9.1CAS number 9007-72-1
    D.3.9.2Current sponsor code004_F
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 4
    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
    D.2.1.1.2Name of the Marketing Authorisation holderABIOGEN PHARMA S.p.A.
    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.3.1Product nameDIBASE
    D.3.2Product code [DIBASE]
    D.3.4Pharmaceutical form Solution for injection
    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 D
    D.3.9.1CAS number 67-97-0
    D.3.9.2Current sponsor code001_D
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100000
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Chronic heart failure; iron deficiency
    Scompenso cardiaco cronico ; carenza marziale
    E.1.1.1Medical condition in easily understood language
    Chronic heart failure; iron deficiency
    Scompenso cardiaco cronico, carenza di ferro
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10019284
    E.1.2Term Heart failure, congestive
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007558
    E.1.2Term Cardiac failure chronic
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10064081
    E.1.2Term Heart failure NYHA class III
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10064080
    E.1.2Term Heart failure NYHA class II
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level LLT
    E.1.2Classification code 10060496
    E.1.2Term Hyposideremia
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to evaluate whether, in patients with chronic heart failure and iron deficiency, the administration of vitamin D in combination with sucrosomial iron is as effective as intravenous ferric carboxymaltose in improving symptoms of heart failure.
    The first aim is to test the non-inferiority of sucrosomial iron treatment compared with the ferric carboxymaltose treatment, after 24 weeks of treatment.
    Lo scopo dello studio è di valutare se nei pazienti con scompenso cardiaco cronico e carenza marziale, la somministrazione di vitamina D in aggiunta al ferro sucrosomiale per via orale possa essere efficace tanto quanto la supplementazione endovenosa nel migliorare i sintomi dello scompenso cardiaco.
    L'obiettivo primario è di testare la non inferiorità del trattamento con il ferro sucrosomiale (integratore) rispetto al ferro carbossimaltosio, dopo 24 settimane di trattamento.
    E.2.2Secondary objectives of the trial
    -Assess quality of life (QoL), physical limitations, symptoms, and limitations in social life (QoL Endpoints)
    - Assess the impact of vitamin D supplementation combined with sucrosomial iron on New York Heart Association (NYHA) class, relevant laboratory and echocardiographic parameters, re-hospitalizations, and mortality in patients with HF and ID (Cardiovascular Endpoints and General Endpoints)
    - Assess the effects of iron supplementation (either intravenous, oral, or with the addition of vitamin D) on calcium-phosphorus metabolism (Calcium-phosphorus metabolism Endpoints)
    -Valutare secondariamente la qualità di vita (QoL), i sintomi e le limitazioni fisiche nella vita sociale legate al HF (QoL Endpoints)
    -Valutare l’impatto della supplementazione di vitamina D combinata con il ferro sucrosomiale per os sulla classe funzionale New York Heart Association (NYHA), su parametri laboratoristici ed ecocardiografici rilevanti, sulle riospedalizzazioni, e sulla mortalità nei pazienti con HF e ID (Endpoints Cardiovascolari ed Endpoins Generali)
    -Valutare gli effetti della supplementazione di ferro (sia per via endovenosa, sia per via orale che sia che con l’aggiunta della vitamina D) sul metabolismo calcio.fosforo (Endpoints metabolismo fosfo-calcico)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Stable symptomatic chronic heart failure (NYHA functional class II-III) and all of the following:
    - At least 3 weeks since the last hospitalization or emergency department access for acute HF.
    - Optimal drug treatment for heart failure (HF) according to the ESC guidelines2 determined by the investigator (unless contraindications or treatment not tolerated).
    - No changes in HF therapy dose in the previous 2 weeks (except diuretics).
    - No new HF therapy in the 3 weeks prior to recruitment.
    - Left ventricle ejection fraction =45%
    - Brain natriuretic peptide >100 pg/mL and/or N-terminal-pro-brain natriuretic peptide >400 pg/mL at pre-recruitment evaluation.
    - Evidence of iron deficiency defined as ferritin <100 ng/ml or TSAT <20% in the case of ferritin levels between 100 and 300 ng/ml.
    - 25-OH-D levels <50 nmol/L.
    - The subject must be able to complete the 6-Minute-Walking -Test.
    - At least 18 years of age.
    Scompenso cardiaco cronico, stabile, sintomatico con classe funzionale NYHA II–III e tutti i seguenti:
    -Almeno 3 settimane dall’ultima ospedalizzazione o accesso in Pronto Soccorso per episodio di scompenso cardiaco acuto
    -Trattamento farmacologico ottimale per lo scompenso cardiaco, secondo le linee guida European Society of Cardiology- ESC, determinato dall’investigator (a meno di controindicazioni o trattamento non tollerato)
    -Nessun cambiamento nella posologia della terapia dello scompenso cardiaco nelle precedenti 2 settimane (ad eccezione dei diuretici)
    -Nessuna nuova terapia per lo scompenso cardiaco introdotta nelle 3 settimane precedenti al reclutamento
    - Frazione d'eiezione =45%
    - Livelli di Brain natriuretic peptide (BNP) >100 pg/mL e/o N-terminal-pro-brain natriuretic peptide (NTproBNP) >400 pg/mL al momento del pre-arruolamento
    - Evidenza di carenza marziale, i.e ferritina <100 ng/ml o TSAT <20% in caso di livelli di ferritina tra 100 e 300 ng/ml
    - Livelli di 25-OH-D <50 nmol/L.
    - - Il soggetto deve essere in grado di completare il 6MClasse funzionale NYHA II–III dovuta a scompenso cardiaco cronico (HF) stabile sintomatico e tutti i seguenti:
    Almeno 3 settimane dall’ultima ospedalizzazione o accesso in Pronto Soccorso per episodio di scompenso cardiaco acuto
    Trattamento farmacologico ottimale per lo scompenso cardiaco, secondo le linee guida European Society of Cardiology- ESC, determinato dall’investigator (a meno di controindicazioni o trattamento non tollerato)
    Nessun cambiamento nella posologia della terapia dello scompenso cardiaco nelle precedenti 2 settimane (ad eccezione dei diuretici)
    Nessuna nuova terapia per lo scompenso cardiaco introdotta nelle 3 settimane precedenti al reclutamento
    FE =45%
    Livelli di Brain natriuretic peptide (BNP) >100 pg/mL e/o N-terminal-pro-brain natriuretic peptide (NTproBNP) >400 pg/mL al momento del pre-arruolamento
    Evidenza di carenza marziale, i.e ferritina <100 ng/ml o TSAT <20% in caso di livelli di ferritina tra 100 e 300 ng/ml
    Livelli di 25-OH-D <50 nmol/L.
    Il soggetto deve essere in grado di completare il 6-Minute-Walking-Test
    Il soggetto deve aver compiuto almeno 18 anni
    E.4Principal exclusion criteria
    -Myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke, coronary artery bypass, percutaneous intervention, or major thoracic or cardiac surgery within the previous 2 months.
    - Clinically relevant (severe) non-corrected valvular heart disease, obstructive cardiomyopathy.
    - Chronic anemia due to non-correctable causes other than iron deficiency and anemia of chronic disease (e.g., hemoglobinopathies, hematologic malignancies, hemolytic anemia).
    - Anemia due to Vitamin B12 or acid folic deficiency. Recruitment may be re-evaluated at least 6 weeks after the end of vitamin B12 and or folic acid supplementation.
    - History of acquired iron overload.
    - Administration of erythropoietin, iron supplementation (either oral or intravenous iron), blood transfusion in the previous 6 weeks or already scheduled for 3 months after recruitment.
    - Administration of vitamin D or similar in the 3 months preceding or already scheduled for the 3 months following recruitment.
    - Severe bone disease.
    - Active infections, C-reactive protein >20 mg/L, clinically significant bleeding, active neoplasm (with exception of basal cell or squamous cell carcinoma of the skin and intraepithelial cervical neoplasia).
    - Chronic liver disease (including active hepatitis) and/or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x normal limit.
    - Immunosuppressive therapy or dialysis.
    - Pregnancy or breastfeeding.
    - The subject has a known sensitivity to any of the products that will be administered during the study protocol.
    - Infarto miocardico o sindrome coronarica acuta, attacco ischemico transitorio o ictus, bypass aorto-coronarico, intervento percutaneo o chirurgia maggiore toracica o cardiaca nei 2 mesi precedenti.
    - Valvulopatia clinicamente rilevante (severa) non corretta, cardiomiopatia ostruttiva
    - Anemia cronica dovuta a cause non correggibili, diverse da carenza marziale e anemia da malattia cronica (ad es emoglobinopatie, neoplasie ematologiche)
    - Anemia legata a carenza di vitamina B12 o folati. L’arruolamento può essere rivalutato dopo almeno 6 settimane dopo il termine della supplementazione di vitamina B12 e folati.
    - Somministrazione di eritropoietina, supplementazione di ferro (sia orale che per via endovenosa), trasfusione di sangue nelle 6 settimane precedenti o già programmate per i 3 mesi successivi al reclutamento
    - Somministrazione di vitamina D o analoghi nei 3 mesi precedenti o già programmate per i 3 mesi successivi al reclutamento
    - Severe malattie dell’osso
    - Stato infettivo in atto, proteina C reattiva > 20 mg/L, sanguinamento clinicamente significativo, neoplasia attiva (ad eccezione di carcinoma sqaumocellulare cutaneo, basalioma cutanei e neoplasia cervicali intraepiteliali)
    - Malattie epatiche croniche (inclusa epatite acuta) e/o valori di alanina aminotransferase (ALT) o aspartato aminotransferasi (AST) >3x limite di normalità
    - Terapia immunosoppressiva o dialisi
    - Stato di gravidanza o allattamento
    - Nota sensibilizzazione ad uno dei prodotti somministrati durante lo studio
    E.5 End points
    E.5.1Primary end point(s)
    The performance of the Six-Minute Walking Test (6MWT), comparing the mean difference from baseline of the distance walked by patients in meters.
    Variazione nella performance al six minutes walking test (6MWT), confrontando la variazione nella distanza percorsa dal paziente in metri rispetto alla distanza basale (mean difference)
    E.5.1.1Timepoint(s) of evaluation of this end point
    This endpoint is evaluating during the outpatient visits at 6-12-24 weeks
    Tale end-point verrà rilevato durante le visite ambulatoriale a 6-12-24 settimane
    E.5.2Secondary end point(s)
    Assess the change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score in the tree-arms treatment during the study; Cardiovascular Endpoints and general endpoints:
    - Change from baseline in the NYHA class in the sucrosomial iron + vitamin D group compared to the control group after 12 and 24 weeks.
    - Change from baseline in the NYHA class in the sucrosomial iron + vitamin D group compared to the sucrosomial iron group after 12 and 24 weeks.
    - Change from baseline in the distance walked at 6-minute-walking-test in the sucrosomial iron + vitamin D group compared to the sucrosomial iron alone after 12 and 24 weeks
    - Change in glomerular filtration rate estimated using the CKD-EPI formula
    - Surviving days out of hospital.
    - Hospitalizations (total, cardiovascular, due to Heart failure).
    - Mortality (total, cardiovascular, due to Heart failure); -Assess the changes in echocardiographic parameters (LVEF, [Simpson's method], left ventricle end diastolic diameter [LVEDD] and left ventricle end systolic diameter [LVESD], left ventricle end diastolic volume [LVEDV], left ventricle end systolic volume [LVESV] Interventricular septal thickness [IVS] and left ventricular posterior wall [PW], diastolic function parameters [E/A ratio, E/e'], left atrial volume index [LAVI], Tricuspid regurgitation [TR] peak velocity) compared with baseline in the sucrosomial iron + vitamin D group after 24 weeks.
    -Assess the changes in echocardiographic parameters (LVEF, LVEDD, LVESD, LVEDV, LVESV, IVS, PW, E/A ratio, E/e', LAVI, TR peak velocity) in the sucrosomial iron + vitamin D group compared with the control group after 24 weeks.; -Assess the plasma levels of calcium, phosphate, and human Fibroblast Growth Factors-23 (FGF-23) in the sucrosomial iron + vitamin D group compared to the control group after 12 and 24 weeks of treatment.
    - Assess the plasma levels of calcium, phosphate and FGF-23 in the sucrosomial iron group compared to the control group after 12 and 24 weeks of treatment.
    -Assess the incidence of fractures in the sucrosomial iron + vitamin D group compared to the control group after 12 and 24 weeks of treatment.
    - Assess the incidence of fractures in the sucrosomial iron group compared to the control group after 12 and 24 weeks of treatment
    Valutare la differenza nello score ottenuto al Kansas City Cardiomyopathy Questionnaire (KCCQ) nei tre bracci di trattamento, durante la durata dello studio; Endpoints Cardiovascolari e general endpoints:
    Variazioni rispetto al basale sulla classe funzionale NYHA nel gruppo ferro sucrosomiale+ vitamina D in confronto con il gruppo controllo dopo 12 e 24 settimane
    Variazioni rispetto al basale sulla classe funzionale NYHA nel gruppo ferro sucrosomiale+ vitamina D in confronto con il gruppo ferro sucrosomiale dopo 12 e 24 settimane
    Variazioni rispetto al basale sulla distanza percorsa al 6-Minute-Walking-Test nel gruppo ferro sucrosomiale+ vitamina D in confronto con il gruppo ferro sucrosomiale dopo 12 e 24 settimane
    Variazione nel filtrato glomerulare stimato tramite formula CKD-EPI
    Giorni sopravvissuti fuori dall’ospedale
    Ospedalizzazioni (totali, cardiovascolari, dovute a scompenso cardiaco)
    Mortalità (totale, cardiovascolare, dovuta a scompenso cardiaco); -Valutare le variazioni dei parametri ecocardiografici rispetto al basale (frazione di eiezione [FE, Simpson’s method], diametro telediastolico e telesistolico del ventricolo sinistro [LVEDD, LVESD], volume di fine diastole del ventricolo sinistro [LVEDV], volume di fine sistole del ventricolo sinistro [LVESV], spessore del setto interventricolare [IVS] e della parete posteriore del ventricolo sinistro [PW], parametri di funzione diastolica [rapporto E/A, E/e’, indice del volume atriale sinistro [LAVI], velocità di picco del rigurgito tricuspidalico [TR]) nel gruppo ferro sucrosomiale + vitamina D dopo 24 settimane
    -Valutare le variazioni dei parametri ecocardiografici (FE, LVEDD, LVESD, LVEDV, LVESV, IVS, PW, rapporto E/A, E/e’, LAVI, velocità di picco TR) nel gruppo ferro sucrosomiale + vitamina D in confronto con il gruppo controllo dopo 24 settimane; -Valutare i livelli di calcio, fosfato ed FGF-23 (fibroblast growth factor-23) nel gruppo ferro sucrosomiale + vitamina D rispetto al gruppo controllo dopo 12 e 24 settimane di trattamento
    - Valutare i livelli di calcio, fosfato ed FGF-23 nel gruppo ferro sucrosomiale rispetto al gruppo controllo dopo 12 e 24 settimane di trattamento
    - Valutare l'incidenza di fratture nel gruppo ferro sucrosomiale + vitamina D rispetto al gruppo controllo dopo 12 e 24 settimane di trattamento
    - Valutare l'incidenza di fratture nel gruppo ferro sucrosomiale rispetto al gruppo controllo dopo 12 e 24 settimane di trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    This endpoint is evaluating during the outpatient visits at 6-12-24 weeks; This endpoint is evaluating during the outpatient visits at 6-12-24 weeks; This endpoint is evaluating during the outpatient visits at 24 weeks; This endpoint is evaluating during the outpatient visits at 6-12-24 weeks
    Tale end-point verrà rilevato durante le visite ambulatoriale a 6-12-24 settimane; Tale end-point verrà rilevato durante le visite ambulatoriale a 6-12-24 settimane; Tale end-point verrà valutato alla visita ambulatoriale a 24 settimane; Tale end-point verrà rilevato durante le visite ambulatoriale a 6-12-24 settimane
    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) 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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    reclutamento sequenziale
    sequential recruitment
    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 trial3
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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 years2
    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 years2
    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.1.1.1In 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 158
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2023-01-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state258
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 258
    F.4.2.2In the whole clinical trial 258
    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)
    n.a.
    n.a.
    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 Decision2023-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-09-14
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 22 18:47:04 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA