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    Summary
    EudraCT Number:2019-002912-25
    Sponsor's Protocol Code Number:1VIT15043
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-08-25
    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 ConcernedLatvia - SAM
    A.2EudraCT number2019-002912-25
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Investigate the Efficacy and Safety of Intravenous Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency
    A.3.2Name or abbreviated title of the trial where available
    HEART-FID
    A.4.1Sponsor's protocol code number1VIT15043
    A.5.4Other Identifiers
    Name:IND #Number:127910
    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 SponsorAmerican Regent, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmerican Regent, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmerican Regent Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address800 Adams Avenue, Suite 200
    B.5.3.2Town/ cityNorristown
    B.5.3.3Post codePA 19403
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 610 650 4200
    B.5.5Fax number+1 610 650 7781
    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 Injectafer®
    D.2.1.1.2Name of the Marketing Authorisation holderAmerican Regent Inc.,
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameInjectafer®
    D.3.4Pharmaceutical form 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 INNFERRIC CARBOXYMALTOSE
    D.3.9.1CAS number 9007-72-1
    D.3.9.4EV Substance CodeSUB66620
    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 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 placeboInjection
    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
    Heart Failure with Iron Deficiency
    E.1.1.1Medical condition in easily understood language
    Heart Failure with Iron Deficiency
    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 10022974
    E.1.2Term Iron deficiency anemia
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10019279
    E.1.2Term 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
    The primary objective of this study is to determine the efficacy and
    safety of iron therapy using intravenous (IV) ferric carboxymaltose
    (FCM), relative to placebo, in the treatment of participants in heart
    failure with a reduced ejection fraction and with iron deficiency.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of IV FCM, relative to placebo, on the functional capacity of patients in heart failure with reduced ejection fraction and with iron deficiency.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult (≥18 years of age) able to provide informed consent.
    2. Stable heart failure (NYHA II-IV) on maximally-tolerated
    background therapy (as determined by the site Principle
    Investigator) for at least 2 weeks prior to randomization.
    3. Able and willing to perform a 6MWT at the time of
    randomization.
    4. Reduced left ventricular ejection fraction. Assessment must be performed at least 12 weeks after major cardiac surgical
    intervention including coronary artery bypass graft (CABG),valvular repair/replacement, or cardiac resynchronization therapy
    (CRT) device implantation.
    a. Left ventricular ejection fraction ≤40% obtained during
    the screening visit OR either of the following
    i. Historical value of ejection fraction ≤40% within 24 months of screening visit
    ii. Historical value of ejection fraction ≤30% within 36 months of screening visit
    5. Hemoglobin >9.0 g/dL and <13.5 g/dL (females) or <15.0 g/dL
    (males) within 28 days of randomization.
    6. Serum ferritin <100 ng/mL or 100 to 300 ng/mL with TSAT
    <20%. Patients with screening ferritin <15 ng/mL must have
    documentation of an appropriate evaluation, as determined by the
    Principle Investigator, within 3 months of screening and prior to
    randomization.
    7. Either documented hospitalization for heart failure within 12
    months of enrollment or elevated N-terminal-pro-brain natriuretic
    peptide (NT-proBNP) within 90 days of randomization:
    a. For patients in normal sinus rhythm: N-terminal-pro-brain
    natriuretic peptide (NT-proBNP) >600 pg/mL (or BNP
    >200 pg/mL)
    b. For patients in atrial fibrillation: NT-proBNP >1000
    pg/mL (or BNP >400 pg/mL
    E.4Principal exclusion criteria
    1. Known hypersensitivity reaction to any component of FCM.
    2. History of acquired iron overload, or the recent receipt (within
    3 months) of erythropoietin stimulating agent, IV iron therapy,
    or blood transfusion.
    3. Acute myocardial infarction, acute coronary syndrome,
    transient ischemic attack, or stroke within 30 days of enrollment.
    4. Uncorrected severe aortic stenosis, severe valvular regurgitation, or left ventricular outflow obstruction requiring intervention.
    5. Current atrial fibrillation or atrial flutter with a mean ventricular response rate >100 per minute (at rest).
    6. Current or planned mechanical circulatory support or heart
    transplantation.
    7. Hemodialysis or peritoneal dialysis (current or planned within
    the next 6 months).
    8. Documented liver disease, or active hepatitis (i.e. alanine
    transaminase or aspartate transaminase >3 times the upper limit of normal range).
    9. Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
    E.5 End points
    E.5.1Primary end point(s)
    Hierarchical composite of 1) death, 2) hospitalization for heart
    failure (defined in section 10.2), or 3) change in 6MWT. (Death and hospitalizations for heart failure will be evaluated at one year,
    Change in 6MWT will be evaluated at 6 months) and tested using the nonparametric Wilcoxon-type test.
    E.5.1.1Timepoint(s) of evaluation of this end point
    as above
    E.5.2Secondary end point(s)
    1. Time to first event of the composite of cardiovascular death or heart failure hospitalization. The composite endpoint will be
    composed of adjudicated occurrence of one of the following:
    a. Cardiovascular Death
    i. Death due to Heart Failure
    ii. Death due to Acute Myocardial Infarction
    iii. Sudden Cardiac Death
    iv. Death due to Stroke
    v. Death due to other Cardiovascular Causes
    b. Hospitalization for Worsening Heart Failure
    2. Mean change in 6MWT from baseline to 12 months
    3. Time to first event of the composite of cardiovascular death or intervention for worsening heart failure (hospitalization or urgent heart failure visits)
    4. Time to first event of the composite of cardiovascular death and cardiovascular hospitalizations
    5. Time to cardiovascular death

    Additional events to be adjudicated for analysis of the secondary endpoints include:
    a) Non-cardiovascular death
    b) Hospitalization for myocardial infarction
    c) Hospitalization for stroke
    d) Other cardiovascular hospitalizations
    e) Urgent heart failure visits
    E.5.2.1Timepoint(s) of evaluation of this end point
    as above
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Bulgaria
    Canada
    Czech Republic
    Estonia
    Georgia
    Hungary
    Latvia
    Lithuania
    New Zealand
    Poland
    Russian Federation
    Ukraine
    United States
    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
    LPLV
    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 years5
    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: 1508
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1508
    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 No
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1508
    F.4.2.2In the whole clinical trial 3014
    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)
    None
    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 Decision2020-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-29
    P. End of Trial
    P.End of Trial StatusCompleted
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