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    Clinical Trial Results:
    Pilot study for evaluation of growth factor erythropoietin beta for improvement of left ventricular function after coronary interventions

    Summary
    EudraCT number
    		 2004-002646-35
    Trial protocol
    		 DE  
    Global end of trial date
    31 Oct 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    08 Mar 2022
    First version publication date
    19 Dec 2021
    Other versions
    		 v1
    Version creation reason
    • Changes to summary attachments
    new version
    Summary report(s)
    		 Link-to publication_2004-002646-35

    Trial information

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    Trial identification
    Sponsor protocol code
    8514077463
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00568542
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    charite-Universitätsmedizin Berlin
    Sponsor organisation address
    Augustenburger Platz 1, Berlin, Germany, 13353
    Public contact
    Martin Bergmann, Franz-Vollhard Clinical Research Center, Campus Buch & Clinic of Cardiology, Campus Virchow Klinikum, +49 40 1818852309, martin.bergmann@charite.de
    Scientific contact
    Martin Bergmann, Franz-Vollhard Clinical Research Center, Campus Buch & Clinic of Cardiology, Campus Virchow Klinikum, +49 40 1818852309, martin.bergmann@charite.de
    Sponsor organisation name
    charite-Universitätsmedizin Berlin
    Sponsor organisation address
    Augustenburger Platz 1, Berlin, Germany, 13353
    Public contact
    Martin Bergmann, Department of Cardiology , ASKLEPIOS KLinik St. Georg, +4940 1818852309, martin.bergmann@charite.de
    Scientific contact
    Martin Bergmann, Franz-Vollhard Clinical Research Center, Campus Buch & Clinic of Cardiology, Campus Virchow Klinikum, +49 40 1818852309, martin.bergmann@charite.de
    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
    31 Oct 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To test the effect of a once weekly dose of erythropietin on left ventricular remodelling after coronary intervention.
    Protection of trial subjects
    low dose treatment following PCI (percutaneos coronary intervention is safe and feasible. Safety: Blood pressure, heart rate, measures of subjective well-being ,adverse events (AE), serious adverse events (SAE), serious adverse reactions (SAR)
    Background therapy
    		 Ischemic heart failure is a major public health burden in western societies. Although technical advancements have improved recascularization of ischemic heart tissue in recent years, data on functional improvement concerning the left ventricle suggest a need for optimization of pharamcological therapie. The growth hormone erythropoietin beta has been shown to improve heart function in various animal models of ischemic heart disease.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Oct 2005
    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
    Germany: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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)
    28
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 We recruited 32 patients. Four patients withdrew consent or presented with exclusion criteria during the screening phase after providing informed consent. Of the remaining 28 patients, 14 were assigned to receive placebo and 14 to receive epoetin-b

    Period 1
    Period 1 title
    Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EPO group
    Arm description
    		 35 I.E. erythropoetin beta given by subcutaneous injection once per week for 6 months. The drug is self-administered.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Erythropoietin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35 I.E. kg body weight subcutaneous once per week for 6 months

    Arm title
    		 Placebo group
    Arm description
    		 Placebo to erythropoetin beta
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    NeoRecormon 10.000 patron
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35 I.E. kg body weight placebo to erythropoetin beta

    Number of subjects in period 1
    		EPO group Placebo group
    Started
    14
    14
    Completed
    13
    11
    Not completed
    1
    3
         Consent withdrawn by subject
    -
    2
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EPO group
    Reporting group description
    		 35 I.E. erythropoetin beta given by subcutaneous injection once per week for 6 months. The drug is self-administered.

    Reporting group title
    Placebo group
    Reporting group description
    		 Placebo to erythropoetin beta

    Reporting group values
    		 EPO group Placebo group Total
    Number of subjects
    		 14 14 28
    Age categorical
    Units: Subjects
        Adults (18-74)
    		 14 14 28
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.0 ± 1.7 61.8 ± 3.0 -
    Gender categorical
    Units: Subjects
        Female
    		 1 2 3
        Male
    		 12 9 21
        N/A
    		 1 3 4

    End points

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    End points reporting groups
    Reporting group title
    EPO group
    Reporting group description
    		 35 I.E. erythropoetin beta given by subcutaneous injection once per week for 6 months. The drug is self-administered.

    Reporting group title
    Placebo group
    Reporting group description
    		 Placebo to erythropoetin beta

    Primary: change of the erythropoietin levels compared to the baseline levels

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    End point title
    		 change of the erythropoietin levels compared to the baseline levels [1]
    End point description
    The individual change in ejection fraction between baseline and 6-month follow-up measured by echocardiography and cardiac MRI was greater in the EPO group than in the placebo group. Both methods of LV function measurement performed in the trial, namely cardiac MRI and echocardiography, are reported in a combined fashion due to the low patient numbers
    End point type
    Primary
    End point timeframe
    6months after baseline
    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: Statistical analyses were not performed due to limeted number of subjects.
    End point values
    		 EPO group Placebo group
    Number of subjects analysed
    13
    11
    Units: mg/dl
    arithmetic mean (standard deviation)
        echocardiographic ejection fraction EF mean (%)
    5.7 ± 1.9
    0.3 ± 1.6
        cardiac MRI ejection fraction EF mean (%)
    3.1 ± 1.6
    -1.9 ± 1.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    6months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 own
    Dictionary version
    1
    Reporting groups
    Reporting group title
    EPO-Group
    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: No non-serious events were given
    Serious adverse events
    		 EPO-Group Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    decompensated heart failure
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 EPO-Group Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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