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    Clinical Trial Results:
    Randomized double-blind explorative controlled clinical trial analyzing the effects of ferric carboxymaltose in patients with iron deficiency and chronic heart failure

    Summary
    EudraCT number
    		 2019-003858-85
    Trial protocol
    		 AT  
    Global end of trial date
    14 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Oct 2022
    First version publication date
    11 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HFIRONT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52, Innsbruck, Austria, 6020
    Public contact
    Univ. Prof. Dr. Günther Weiss, Medical University Innsbruck, Department of Internal Medicine II, Anichstrasse 35, 6020 IBK, 0043 0512504 23251, guenter.weiss@i-med.ac.at
    Scientific contact
    Univ. Prof. Dr. Günther Weiss, Medical University Innsbruck, Department of Internal Medicine II, Anichstrasse 35, 6020 IBK, 0043 0512504 23251, guenter.weiss@i-med.ac.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Dec 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Dec 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Dec 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Primary objective of this study is to identify the mechanism(s) underlying the beneficial effects of iron supplementation in iron-deficient patients with CHF.
    Protection of trial subjects
    Administration of intravenous iron is considered a safe procedure, but severe hypersensitivity reactions (HSRs) can occur at a very low frequency. However, the frequency of such HSR is less than 0,01 % and comparable with administration of paracetamol or ibuprofen.
    Background therapy
    		 Patients should be on optimized background therapy according to the ESC guidelines 2016 for the diagnosis and treatment of acute and chronic heart failure. Changes or improvement in heart failure medication – if needed – are allowed throughout the study period except for the additional administration of iron preparation. Individually optimized long-term treatment will be recorded as well as relevant concomitant medication, which is intended to treat AEs. No other investigational product is allowed to be used concomitantly with the study treatment. The patient must not have been administered another investigational product within 30 days before the baseline visit.
    Evidence for comparator
    		 There is no evidence for comparators
    Actual start date of recruitment
    02 Jan 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    2
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Candidates for the study will be screened during their scheduled visits at the cardiology ambulance for chronic heart failure (CHF) and concomitant iron deficiency (ID). If the patient meets all the inclusion criteria and none of the exclusion criteria, a baseline visit will be arranged.

    Pre-assignment
    Screening details
    		 Candidates for the study will be screened during their scheduled visits at the cardiology ambulance for chronic heart failure (CHF) and concomitant iron deficiency (ID).

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Randomization will be done by an independent expert at the Institute of Medical Statistics and Informatics applying the permuted block method.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ferric carboxymaltose
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ferric Carboxymaltose
    Investigational medicinal product code
    Other name
    Ferinject
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg of ferric carboxymaltose (Ferinject®) will be given in 50 mL sterile sodium chloride 0.9 % via perfusor over a period of 60 minutes. It will be provided by the dispensary of the Innsbruck University Hospital in a black perfusor syringe and will be administered via a black perfusion line.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodiumchloride 0,9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sodium chloride 0.9% will be given via a perfusor over 60 minutes. It will be provided by the dispensary of the Innsbruck University Hospital in a black perfusor syringe and will be administered via a black perfusion line.

    Number of subjects in period 1
    		Ferric carboxymaltose Placebo
    Started
    1
    1
    Completed
    1
    0
    Not completed
    0
    1
         Adverse event, serious fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Total
    Number of subjects
    		 2 2
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 2 2
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 56.5 (54 to 59) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Ferric carboxymaltose
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Blood count

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    End point title
    		 Blood count [1]
    End point description
    We will determine the effects of a single ferric carboxymaltose infusion as compared to placebo administration on blood count including reticulocyte count and reticulocyte hemoglobin content.
    End point type
    Primary
    End point timeframe
    Screening - follow-up visit 2
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As only one patient finished this trial no statistical analysis was done.
    End point values
    		 Ferric carboxymaltose Placebo
    Number of subjects analysed
    0 [2]
    1 [3]
    Units: cell number
        number (not applicable)
    99999
    Notes
    [2] - Patient droped out of study before end of trial
    [3] - "99999" is a value for 0 as no analysis was done
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    02.01.2020-14.12.2021
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Ferric carboxymaltose
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Only two patients were enrolled in this trial. No Adverse Event was observed.
    Serious adverse events
    		 Ferric carboxymaltose Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    1
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ferric carboxymaltose Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Mar 2020
    Change from paper-based CRF to electronic CRF
    30 Mar 2020
    Temporary stop of recruitment due to Covid 19
    19 May 2020
    Resumption of recruitment after temporary stop due to Covid 19

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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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
    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.

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