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    Clinical Trial Results:
    REPETITIVE LEVOSIMENDAN INFUSIONS FOR PATIENTS WITH ADVANCED CHRONIC HEART FAILURE

    Summary
    EudraCT number
    		 2017-002429-39
    Trial protocol
    		 AT   DE   HU   SI   FI   DK   IT  
    Global end of trial date
    31 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jan 2023
    First version publication date
    08 Jan 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Leodor2017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03437226
    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. Gerhard Pölzl, Medical University Innsbruck,University Hospital for Internal Medicine III,Anichstrasse 35,6020 Ibk., +43 (0)512 504 25621, gerhard.poelzl@tirol-kliniken.at
    Scientific contact
    Univ.Prof. Dr. Gerhard Pölzl, Medical University Innsbruck,University Hospital for Internal Medicine III,Anichstrasse 35,6020 Ibk., +43 (0)512 504 25621, gerhard.poelzl@tirol-kliniken.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
    31 Dec 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary efficacy objective of the study is to compare the effects of pulsed application of levosimendan versus placebo in patients with advanced chronic heart failure during a vulnerable period of 14 weeks following a recent hospitalisation on a global rank endpoint in which all participants are ranked across three hierarchical groups: • time to death or high-urgent heart transplantation or ventricular assist device (VAD), • time to non-fatal HF event requiring i.v. vasoactive therapy (i.v. diuretics, i.v. vasodilators or i.v. inotropes) and • time-averaged proportional change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline to 14 weeks.
    Protection of trial subjects
    The patients will be under optimal medical treatment for HF and the study drug will be administered ontop of the patients’ on-going medication. Thus placebo as a control can be ethically justified.
    Background therapy
    		 Patients should be on optimised 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 levosimendan.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovenia: 10
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    Austria: 39
    Country: Number of subjects enrolled
    Denmark: 8
    Country: Number of subjects enrolled
    Finland: 3
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Hungary: 51
    Country: Number of subjects enrolled
    Italy: 26
    Worldwide total number of subjects
    148
    EEA total number of subjects
    148
    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)
    50
    From 65 to 84 years
    94
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 Candidates for the study will be screened during their hospitalisation for acute decompensated HF. 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 hospitalisation for acute decompensated HF. If the patient meets all the inclusion criteria and none of the exclusion criteria, a baseline visit will be arranged.

    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
    The randomisation will be performed by the Department of Medical Statistics, Informatics and Health Economics at Medical University Innsbruck and the treatment codes will be stored in the eCRF database. The codes will be delivered to the accredited pharmacy responsible of labelling the study medications. Each study centre is provided with unblinders containing information on the study treatments.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 6-hour infusion group Levosimendan
    Arm description
    		 Patients will receive a 6-hour infusion every 2 weeks up to 12 weeks,followed by a follow-up visit (FUP1) at week 14 and another follow-up visit (FUP2) at 6 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Levosimendan
    Investigational medicinal product code
    Other name
    Simdax
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    For the 6-hour infusion group, the study drug is administered at a continuous infusion rate of 0.2 μg/kg/min, for 6 hours.

    Arm title
    		 24-hour infusion group Levosimendan
    Arm description
    		 Patients will receive a 24-hour infusion every 3 weeks up to 12 weeks, followed by a follow-up visit (FUP1) at week 14 and another follow-up visit (FUP2) at 6 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Levosimendan
    Investigational medicinal product code
    Other name
    Simdax
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    For the 24-hour infusion group, the study drug is administered at a continuous infusion rate of 0.1 μg/kg/min, for 24 hours.

    Arm title
    		 6-hour infusion group Placebo
    Arm description
    		 Patients will receive a 6-hour infusion every 2 weeks up to 12 weeks,followed by a follow-up visit (FUP1) at week 14 and another follow-up visit (FUP2) at 6 months.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    For the 6-hour infusion group, the study drug/Placebo is administered at a continuous infusion rate of 0.1 μg/kg/min, for 24 hours.

    Arm title
    		 24-hour infusion group Placebo
    Arm description
    		 Patients will receive a 24-hour infusion every 3 weeks up to 12 weeks, followed by a follow-up visit (FUP1) at week 14 and another follow-up visit (FUP2) at 6 months.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    For the 24-hour infusion group, the study drug/Placebo is administered at a continuous infusion rate of 0.1 μg/kg/min, for 24 hours.

    Number of subjects in period 1
    		6-hour infusion group Levosimendan 24-hour infusion group Levosimendan 6-hour infusion group Placebo 24-hour infusion group Placebo
    Started
    38
    57
    22
    31
    Completed
    26
    39
    17
    23
    Not completed
    12
    18
    5
    8
         Adverse event, serious fatal
    3
    10
    1
    3
         Physician decision
    1
    2
    2
    2
         Consent withdrawn by subject
    4
    2
    -
    2
         Screening failure
    1
    -
    -
    -
         Adverse event, non-fatal
    2
    4
    -
    1
         Covid 19
    1
    -
    1
    -
         Lost to follow-up
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    6-hour infusion group Levosimendan
    Reporting group description
    		 Patients will receive a 6-hour infusion every 2 weeks up to 12 weeks,followed by a follow-up visit (FUP1) at week 14 and another follow-up visit (FUP2) at 6 months.

    Reporting group title
    24-hour infusion group Levosimendan
    Reporting group description
    		 Patients will receive a 24-hour infusion every 3 weeks up to 12 weeks, followed by a follow-up visit (FUP1) at week 14 and another follow-up visit (FUP2) at 6 months.

    Reporting group title
    6-hour infusion group Placebo
    Reporting group description
    		 Patients will receive a 6-hour infusion every 2 weeks up to 12 weeks,followed by a follow-up visit (FUP1) at week 14 and another follow-up visit (FUP2) at 6 months.

    Reporting group title
    24-hour infusion group Placebo
    Reporting group description
    		 Patients will receive a 24-hour infusion every 3 weeks up to 12 weeks, followed by a follow-up visit (FUP1) at week 14 and another follow-up visit (FUP2) at 6 months.

    Reporting group values
    		 6-hour infusion group Levosimendan 24-hour infusion group Levosimendan 6-hour infusion group Placebo 24-hour infusion group Placebo Total
    Number of subjects
    		 38 57 22 31 148
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 7 23 9 10 49
        From 65-84 years
    		 28 34 12 21 95
        85 years and over
    		 3 0 1 0 4
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 72.1 (52 to 86) 67.4 (49 to 84) 67.4 (46 to 87) 68.5 (51 to 82) -
    Gender categorical
    Units: Subjects
        Female
    		 6 14 17 6 43
        Male
    		 32 43 5 25 105

    End points

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    End points reporting groups
    Reporting group title
    6-hour infusion group Levosimendan
    Reporting group description
    		 Patients will receive a 6-hour infusion every 2 weeks up to 12 weeks,followed by a follow-up visit (FUP1) at week 14 and another follow-up visit (FUP2) at 6 months.

    Reporting group title
    24-hour infusion group Levosimendan
    Reporting group description
    		 Patients will receive a 24-hour infusion every 3 weeks up to 12 weeks, followed by a follow-up visit (FUP1) at week 14 and another follow-up visit (FUP2) at 6 months.

    Reporting group title
    6-hour infusion group Placebo
    Reporting group description
    		 Patients will receive a 6-hour infusion every 2 weeks up to 12 weeks,followed by a follow-up visit (FUP1) at week 14 and another follow-up visit (FUP2) at 6 months.

    Reporting group title
    24-hour infusion group Placebo
    Reporting group description
    		 Patients will receive a 24-hour infusion every 3 weeks up to 12 weeks, followed by a follow-up visit (FUP1) at week 14 and another follow-up visit (FUP2) at 6 months.

    Primary: Heart transplantation

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    End point title
    		 Heart transplantation [1]
    End point description
    The primary efficacy objective of the study is to compare the effects of pulsed application of levosimendan versus placebo in patients with advanced chronic heart failure during a vulnerable period of 14 weeks.
    End point type
    Primary
    End point timeframe
    Week 0-week 14
    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: With total of 264 patients, study has approximately 90% power to detect statistically significant difference between treatments. Only 148 patients were enrolled.
    End point values
    		 6-hour infusion group Levosimendan 24-hour infusion group Levosimendan 6-hour infusion group Placebo 24-hour infusion group Placebo
    Number of subjects analysed
    38
    57
    22
    31
    Units: number
        number (not applicable)
    0
    0
    2
    0
    No statistical analyses for this end point

    Primary: Implantation of a VAD

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    End point title
    		 Implantation of a VAD [2]
    End point description
    The primary efficacy objective of the study is to compare the effects of pulsed application of levosimendan versus placebo in patients with advanced chronic heart failure during a vulnerable period of 14 weeks.
    End point type
    Primary
    End point timeframe
    Week 0-week 14
    Notes
    [2] - 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: With total of 264 patients, study has approximately 90% power to detect statistically significant difference between treatments. Only 148 patients were enrolled.
    End point values
    		 6-hour infusion group Levosimendan 24-hour infusion group Levosimendan 6-hour infusion group Placebo 24-hour infusion group Placebo
    Number of subjects analysed
    38
    57
    22
    31
    Units: number
        number (not applicable)
    1
    0
    0
    0
    No statistical analyses for this end point

    Primary: Death

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    End point title
    		 Death [3]
    End point description
    The primary efficacy objective of the study is to compare the effects of pulsed application of levosimendan versus placebo in patients with advanced chronic heart failure during a vulnerable period of 14 weeks.
    End point type
    Primary
    End point timeframe
    Week 0- week 14
    Notes
    [3] - 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: With total of 264 patients, study has approximately 90% power to detect statistically significant difference between treatments. Only 148 patients were enrolled.
    End point values
    		 6-hour infusion group Levosimendan 24-hour infusion group Levosimendan 6-hour infusion group Placebo 24-hour infusion group Placebo
    Number of subjects analysed
    38
    57
    22
    31
    Units: number
        number (not applicable)
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    08.11.2017-31.12.2021
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    6.0
    Reporting groups
    Reporting group title
    6-hour infusion group Levosimendan
    Reporting group description
    		 Patients will receive a 6-hour infusion every 2 weeks up to 12 weeks,followed by a follow-up visit (FUP1) at week 14 and another follow-up visit (FUP2) at 6 months.

    Reporting group title
    24-hour infusion group Levosimendan
    Reporting group description
    		 Patients will receive a 24-hour infusion every 3 weeks up to 12 weeks, followed by a follow-up visit (FUP1) at week 14 and another follow-up visit (FUP2) at 6 months.

    Reporting group title
    6-hour infusion group Placebo
    Reporting group description
    		 Patients will receive a 6-hour infusion every 2 weeks up to 12 weeks,followed by a follow-up visit (FUP1) at week 14 and another follow-up visit (FUP2) at 6 months.

    Reporting group title
    24-hour infusion group Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 6-hour infusion group Levosimendan 24-hour infusion group Levosimendan 6-hour infusion group Placebo 24-hour infusion group Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 38 (34.21%)
    33 / 57 (57.89%)
    11 / 22 (50.00%)
    15 / 31 (48.39%)
         number of deaths (all causes)
    3
    10
    1
    3
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Cardiac disorders
    Cardiac decompensation
         subjects affected / exposed
    6 / 38 (15.79%)
    3 / 57 (5.26%)
    6 / 22 (27.27%)
    4 / 31 (12.90%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 19
    0 / 19
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Worsening of heart failure
         subjects affected / exposed
    2 / 38 (5.26%)
    15 / 57 (26.32%)
    4 / 22 (18.18%)
    2 / 31 (6.45%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 23
    0 / 23
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    2 / 38 (5.26%)
    5 / 57 (8.77%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 57 (1.75%)
    2 / 22 (9.09%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Edema
         subjects affected / exposed
    2 / 38 (5.26%)
    3 / 57 (5.26%)
    2 / 22 (9.09%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 57 (1.75%)
    1 / 22 (4.55%)
    4 / 31 (12.90%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 38 (0.00%)
    4 / 57 (7.02%)
    0 / 22 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthopnoea
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 57 (1.75%)
    2 / 22 (9.09%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 57 (1.75%)
    1 / 22 (4.55%)
    4 / 31 (12.90%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 6-hour infusion group Levosimendan 24-hour infusion group Levosimendan 6-hour infusion group Placebo 24-hour infusion group Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 38 (60.53%)
    42 / 57 (73.68%)
    14 / 22 (63.64%)
    21 / 31 (67.74%)
    Cardiac disorders
    Worsening of heart failure
         subjects affected / exposed
    5 / 38 (13.16%)
    13 / 57 (22.81%)
    6 / 22 (27.27%)
    1 / 31 (3.23%)
         occurrences all number
    25
    25
    25
    25
    Cardiac decompensation
         subjects affected / exposed
    6 / 38 (15.79%)
    3 / 57 (5.26%)
    2 / 22 (9.09%)
    3 / 31 (9.68%)
         occurrences all number
    14
    14
    14
    14
    Ventricular tachycardia
         subjects affected / exposed
    1 / 38 (2.63%)
    8 / 57 (14.04%)
    3 / 22 (13.64%)
    1 / 31 (3.23%)
         occurrences all number
    13
    13
    13
    13
    Heart failure
         subjects affected / exposed
    0 / 38 (0.00%)
    3 / 57 (5.26%)
    0 / 22 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    5
    5
    5
    5
    Atrial fibrillation
         subjects affected / exposed
    3 / 38 (7.89%)
    0 / 57 (0.00%)
    0 / 22 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    4
    4
    4
    4
    Cardiogenic shock
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 57 (3.51%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    4
    4
    4
    4
    Blood and lymphatic system disorders
    Hypotension
         subjects affected / exposed
    10 / 38 (26.32%)
    9 / 57 (15.79%)
    3 / 22 (13.64%)
    6 / 31 (19.35%)
         occurrences all number
    28
    28
    28
    28
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    0 / 38 (0.00%)
    3 / 57 (5.26%)
    0 / 22 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    4
    4
    4
    4
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 57 (1.75%)
    1 / 22 (4.55%)
    7 / 31 (22.58%)
         occurrences all number
    11
    11
    11
    11
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 57 (3.51%)
    1 / 22 (4.55%)
    0 / 31 (0.00%)
         occurrences all number
    4
    4
    4
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Apr 2018
    *Revised protocol, V1.5 *ICF V1.2 *New subinvestigators
    17 Sep 2019
    *Revised protocol V1.8 *Additional sites in Italy, Sweden and Danmark *Trial duration extended to 31-DEC-2021 *New Subinvestigtors *Change of sponsor contact
    04 Jun 2020
    Amendment of exclusion criteria 11

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    23 Mar 2020
    The safety and well-being of patients participating in LeoDOR, as well as the personnel at each site, are of the utmost importance to the sponsor. The sponsor has decided to conduct a temporary hold until the situation is considerably improved .
    11 May 2020

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30378288
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