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    Clinical Trial Results:
    The effect of metoprolol on myocardial function, hemodynamics and heart failure symptoms in patients with hypertrophic obstructive cardiomyopathy

    Summary
    EudraCT number
    		 2017-004478-32
    Trial protocol
    		 DK  
    Global end of trial date
    01 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Nov 2021
    First version publication date
    17 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    03-11-2017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensen Blvd. 99, Aarhus N, Denmark, 8200
    Public contact
    Steen Hvitfeldt Poulsen, Aarhus University Hospital, steepoul@rm.dk
    Scientific contact
    Steen Hvitfeldt Poulsen, Aarhus University Hospital, steepoul@rm.dk
    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
    29 Oct 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We want to quantify the effect of metoprololsuccinat on myocardial function, hemodynamics and symptoms in patients with hypertrophic obstructive cardiomyopathy.
    Protection of trial subjects
    The study was conducted in accordance with the protocol, consistent to ICH-GCP and applicable local regulatory requirements. The written informed consent with a declaration of data privacy was signed and dated by the subject. The study was monitored externally by the Good Clinical Practice Unit at Aarhus University.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2018
    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
    Denmark: 29
    Worldwide total number of subjects
    29
    EEA total number of subjects
    29
    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)
    16
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period: May 1, 2018, and September 1, 2020.

    Pre-assignment
    Screening details
    		 73 patients were screened.

    Period 1
    Period 1 title
    1 Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    For blinding of the tablets, both metoprolol and placebo was capsulated in gelatin for an identical apperance.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo First
    Arm description
    		 Subjects were randomised to Placebo first and Metoprolol second
    Arm type
    		 Crossover

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    three tablets once daily

    Arm title
    		 Metoprolol First
    Arm description
    		 Subjects were randomised to Metoprolol first and Placebo second.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Metoprololsuccinate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    three tablets once daily, corrresponding to 150 mg

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three tablet once daily

    Number of subjects in period 1
    		Placebo First Metoprolol First
    Started
    14
    15
    Completed
    14
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    1 Period
    Reporting group description
    		 -

    Reporting group values
    		 1 Period Total
    Number of subjects
    		 29 29
    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)
    		 16 16
        From 65-84 years
    		 13 13
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60 ( 11 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 18 18

    End points

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    End points reporting groups
    Reporting group title
    Placebo First
    Reporting group description
    		 Subjects were randomised to Placebo first and Metoprolol second

    Reporting group title
    Metoprolol First
    Reporting group description
    		 Subjects were randomised to Metoprolol first and Placebo second.

    Primary: delta PCWP

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    End point title
    		 delta PCWP
    End point description
    delta (exercise - rest) change in pulmonary capillary wedge pressure (PCWP)
    End point type
    Primary
    End point timeframe
    two weeks in each arm
    End point values
    		 Placebo First Metoprolol First
    Number of subjects analysed
    14
    14
    Units: mmHg
        arithmetic mean (standard deviation)
    23 ( 9 )
    21 ( 9 )
    Statistical analysis title
    		 Paired students t-test
    Statistical analysis description
    Within patient difference.
    Comparison groups
    Placebo First v Metoprolol First
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 weeks
    Adverse event reporting additional description
    Information about adverse events were collected both during routinely scheduled visits as well when subjects opportunistically contacted the researchers.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Metoprolol
    Reporting group description
    		 Metoprolol

    Serious adverse events
    		 Placebo Metoprolol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Metoprolol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 15 (100.00%)
    17 / 17 (100.00%)
    Vascular disorders
    Freezing phenomenon
    Additional description: cold hands and feet
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    2 / 15 (13.33%)
    3 / 17 (17.65%)
         occurrences all number
    2
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 15 (13.33%)
    3 / 17 (17.65%)
         occurrences all number
    2
    3
    Dizziness
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 17 (5.88%)
         occurrences all number
    2
    1
    Restless legs syndrome
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 15 (20.00%)
    2 / 17 (11.76%)
         occurrences all number
    3
    2
    Respiratory, thoracic and mediastinal disorders
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 17 (5.88%)
         occurrences all number
    2
    1
    Skin and subcutaneous tissue disorders
    Infection
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    0
    2
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Infections and infestations
    Cough
         subjects affected / exposed
    3 / 15 (20.00%)
    2 / 17 (11.76%)
         occurrences all number
    3
    2

    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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