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    Clinical Trial Results:
    Hypertrophic CARdiomyopathy symptom release by alpha stimulant MIDOdrine

    Summary
    EudraCT number
    		 2015-003521-34
    Trial protocol
    		 FR  
    Global end of trial date
    06 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Sep 2026
    First version publication date
    18 Sep 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CHUBX 2015/14
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02590809
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU de Bordeaux
    Sponsor organisation address
    12 rue dubernat, Talence, France,
    Public contact
    Pr LAFITTE Stephane Service médico-chirurgical des valvulopathies et cardiomyopathies - Chirurgie, CHU de bordeaux, stephane.lafitte@chu-bordeaux.fr
    Scientific contact
    Pr LAFITTE Stephane Service médico-chirurgical des valvulopathies et cardiomyopathies - Chirurgie, CHU de bordeaux, stephane.lafitte@chu-bordeaux.fr
    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
    06 Jul 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the results of the 6-minute walk test (6MWT) at 2 weeks (D15), in HCM patients with exercise obstruction, between two parallel groups of midodrine hydrochloride treatment, placebo.
    Protection of trial subjects
    NI-CE avec MR
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Oct 2015
    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
    France: 38
    Worldwide total number of subjects
    38
    EEA total number of subjects
    38
    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)
    25
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Date of first inclusion: 07/10/2015 Date of last inclusion: 07/06/2016 One center in France participated on the study

    Pre-assignment
    Screening details
    		 - Adults aged 18-80 years of both sexes - Patients with typical or atypical hypertrophic cardiomyopathy diagnosed by cardiac imaging (echocardiography and MRI) and/or genetic testing or family history - Treadmill obstruction (sub-aortic obstruction > 50 mmHg measured in continuous Doppler aligned with aortic ejection) - Positive response

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Chlorydrate of midodrine group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Treatment BX1514M
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    X mg x 3 /day of BX1514M for 15 days. Dosage will be then adapted, depending on symptoms release and walk distance test results for another 15 days period.

    Arm title
    		 Placebo group
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo will be given oraly for 30 days

    Number of subjects in period 1
    		Chlorydrate of midodrine group Placebo group
    Started
    18
    20
    Completed
    18
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Chlorydrate of midodrine group
    Reporting group description
    		 -

    Reporting group title
    Placebo group
    Reporting group description
    		 -

    Reporting group values
    		 Chlorydrate of midodrine group Placebo group Total
    Number of subjects
    		 18 20 38
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.2 ( 12.3 ) 56.7 ( 11.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 6 14
        Male
    		 10 14 24

    End points

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    End points reporting groups
    Reporting group title
    Chlorydrate of midodrine group
    Reporting group description
    		 -

    Reporting group title
    Placebo group
    Reporting group description
    		 -

    Primary: Distance travelled, in metres, in the 6-minute walk test (6MWT) at 15 days

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    End point title
    		 Distance travelled, in metres, in the 6-minute walk test (6MWT) at 15 days
    End point description
    End point type
    Primary
    End point timeframe
    At 15 days
    End point values
    		 Chlorydrate of midodrine group Placebo group
    Number of subjects analysed
    17
    19
    Units: meter
        arithmetic mean (standard deviation)
    529.6 ( 81.3 )
    551.4 ( 109.0 )
    Statistical analysis title
    		 Description of the distance covered at D15
    Comparison groups
    Chlorydrate of midodrine group v Placebo group
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5046
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Distance travelled, in metres, during the 6-minute walk test (6MWT) at D30

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    End point title
    		 Distance travelled, in metres, during the 6-minute walk test (6MWT) at D30
    End point description
    End point type
    Secondary
    End point timeframe
    At 30 days
    End point values
    		 Chlorydrate of midodrine group Placebo group
    Number of subjects analysed
    15
    18
    Units: meter
        arithmetic mean (standard deviation)
    547.3 ( 91.8 )
    576.3 ( 100.5 )
    Statistical analysis title
    		 Description of the distance covered at D30
    Comparison groups
    Chlorydrate of midodrine group v Placebo group
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3964
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Measurement of intraventricular obstruction at rest, by Doppler evaluation of the intraventricular obstruction parameter, at D15

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    End point title
    		 Measurement of intraventricular obstruction at rest, by Doppler evaluation of the intraventricular obstruction parameter, at D15
    End point description
    Maximum obstruction gradient at D15 is measured during resting echography
    End point type
    Secondary
    End point timeframe
    At 15 days
    End point values
    		 Chlorydrate of midodrine group Placebo group
    Number of subjects analysed
    17
    18
    Units: millimeter(s) of mercury
        arithmetic mean (standard deviation)
    49.8 ( 45.4 )
    34.9 ( 30.2 )
    Statistical analysis title
    		 Description of intraventricular obstruction at D15
    Comparison groups
    Chlorydrate of midodrine group v Placebo group
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6318
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Measurement of intraventricular obstruction during exercise, by Doppler evaluation of the intraventricular obstruction parameter, at D15

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    End point title
    		 Measurement of intraventricular obstruction during exercise, by Doppler evaluation of the intraventricular obstruction parameter, at D15
    End point description
    Maximum obstruction gradient at D15 is measured during the exercise echography on a mat at rest
    End point type
    Secondary
    End point timeframe
    At 15 days
    End point values
    		 Chlorydrate of midodrine group Placebo group
    Number of subjects analysed
    15
    19
    Units: millimeter(s) of mercury
        arithmetic mean (standard deviation)
    59.2 ( 46.2 )
    36.9 ( 23.2 )
    Statistical analysis title
    		 Description of intraventricular obstruction at D15
    Comparison groups
    Chlorydrate of midodrine group v Placebo group
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4447
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Measurement of intraventricular obstruction at rest, by Doppler evaluation of the intraventricular obstruction parameter, at D30

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    End point title
    		 Measurement of intraventricular obstruction at rest, by Doppler evaluation of the intraventricular obstruction parameter, at D30
    End point description
    Maximum obstruction gradient at D30 is measured during resting echography
    End point type
    Secondary
    End point timeframe
    At 30 days
    End point values
    		 Chlorydrate of midodrine group Placebo group
    Number of subjects analysed
    15
    18
    Units: millimeter(s) of mercury
        arithmetic mean (standard deviation)
    50.9 ( 42.4 )
    24.4 ( 17.5 )
    Statistical analysis title
    		 Description of intraventricular obstruction at D30
    Comparison groups
    Chlorydrate of midodrine group v Placebo group
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1637
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Measurement of intraventricular obstruction during exercise, by Doppler evaluation of the intraventricular obstruction parameter, at D30

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    End point title
    		 Measurement of intraventricular obstruction during exercise, by Doppler evaluation of the intraventricular obstruction parameter, at D30
    End point description
    Maximum obstruction gradient at D30 is measured during the stress echography on a mat at rest.
    End point type
    Secondary
    End point timeframe
    At 30 days
    End point values
    		 Chlorydrate of midodrine group Placebo group
    Number of subjects analysed
    13
    17
    Units: millimeter(s) of mercury
        arithmetic mean (standard deviation)
    53.2 ( 36.8 )
    42.5 ( 25.4 )
    Statistical analysis title
    		 Description of intraventricular obstruction at D30
    Comparison groups
    Chlorydrate of midodrine group v Placebo group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7062
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: NYHA functional class at D15

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    End point title
    		 NYHA functional class at D15
    End point description
    End point type
    Secondary
    End point timeframe
    At 15 days
    End point values
    		 Chlorydrate of midodrine group Placebo group
    Number of subjects analysed
    18
    18
    Units: percent
    number (not applicable)
        Class 1
    16.7
    11.1
        Class 2
    61.1
    61.1
        Class 3
    16.7
    27.8
        Class 4
    5.6
    0
    No statistical analyses for this end point

    Secondary: NYHA functional class at D30

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    End point title
    		 NYHA functional class at D30
    End point description
    End point type
    Secondary
    End point timeframe
    At 30 days
    End point values
    		 Chlorydrate of midodrine group Placebo group
    Number of subjects analysed
    15
    16
    Units: percent
    number (not applicable)
        Class 1
    20.0
    18.8
        Class 2
    53.3
    68.8
        Class 3
    26.7
    12.5
    No statistical analyses for this end point

    Secondary: The CCS pain score at D30

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    End point title
    		 The CCS pain score at D30
    End point description
    End point type
    Secondary
    End point timeframe
    At 30 days
    End point values
    		 Chlorydrate of midodrine group Placebo group
    Number of subjects analysed
    15
    16
    Units: percent
    number (not applicable)
        Class I
    80
    75
        Class II
    20
    25
    No statistical analyses for this end point

    Secondary: B-type natriuretic peptide (BNP) at D30

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    End point title
    		 B-type natriuretic peptide (BNP) at D30
    End point description
    End point type
    Secondary
    End point timeframe
    At 30 days
    End point values
    		 Chlorydrate of midodrine group Placebo group
    Number of subjects analysed
    15
    18
    Units: picogram(s)/mililitre
        arithmetic mean (standard deviation)
    383.4 ( 548.3 )
    279.2 ( 310.5 )
    Statistical analysis title
    		 Description of BNP
    Comparison groups
    Chlorydrate of midodrine group v Placebo group
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7312
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Echocardiography - Blood pressure, resting SBP at D30

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    End point title
    		 Echocardiography - Blood pressure, resting SBP at D30
    End point description
    End point type
    Secondary
    End point timeframe
    At 30 days
    End point values
    		 Chlorydrate of midodrine group Placebo group
    Number of subjects analysed
    14
    16
    Units: millimeter(s) of mercury
        arithmetic mean (standard deviation)
    119.2 ( 15.9 )
    119.3 ( 17.1 )
    Statistical analysis title
    		 Description of the blood pressure
    Comparison groups
    Chlorydrate of midodrine group v Placebo group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9872
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall study
    Adverse event reporting additional description
    These adverse events are described by Preferred Terms (PT)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Chlorydrate of midodrine group
    Reporting group description
    		 -

    Reporting group title
    Placebo group
    Reporting group description
    		 -

    Serious adverse events
    		 Chlorydrate of midodrine group Placebo group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 20 (5.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Cardiac failure (10007554)
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia (10002034)
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haemorrhoids (10019022)
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema (10001029)
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea (10013968)
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Chlorydrate of midodrine group Placebo group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 18 (55.56%)
    8 / 20 (40.00%)
    Investigations
    Brain natriuretic peptide increased (10053405)
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Blood creatinine increased (10005483)
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypotension (10021097)
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Hot flush (10060800)
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Therapy cessation (10065154)
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Cardiac disorders
    Palpitations (10033557)
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache (10019211)
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Dizziness (10013573)
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Presyncope (10036653)
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia (10033775)
         subjects affected / exposed
    4 / 18 (22.22%)
    0 / 20 (0.00%)
         occurrences all number
    4
    0
    Migraine (10027599)
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Chills (10008531)
         subjects affected / exposed
    3 / 18 (16.67%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Fatigue (10016256)
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Malaise (10025482)
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Influenza like illness (10022004)
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Vomiting (10047700)
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea (10013968)
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Urticaria (10046735)
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Pruritus (10037087)
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Piloerection (10035039)
         subjects affected / exposed
    4 / 18 (22.22%)
    0 / 20 (0.00%)
         occurrences all number
    4
    0
    Psychiatric disorders
    Agitation (10001497)
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Nervousness (10029216)
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Libido disorder (10061221)
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Insomnia (10022437)
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Infections and infestations
    Acarodermatitis (10063409)
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Gastroenteritis (10017888)
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26898633
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