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    Clinical Trial Results:
    Does Allopurinol regress Left Ventricular Hypertrophy in Patients with Treated Essential Hypertension?

    Summary
    EudraCT number
    		 2014-002083-33
    Trial protocol
    		 GB  
    Global end of trial date
    26 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Dec 2019
    First version publication date
    20 Dec 2019
    Other versions
    Summary report(s)
    		 ALLAY Abstract

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    2012CV15
    Additional study identifiers
    ISRCTN number
    		 ISRCTN40476871
    US NCT number
    		 NCT02237339
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Sponsor Reference: 2012CV15
    Sponsors
    Sponsor organisation name
    University of Dundee
    Sponsor organisation address
    Ninewells Hospital, Dundee DD1 9SY, Dundee, United Kingdom, DD1 9SY
    Public contact
    McSwiggan, University of Dundee, 01382 383233, s.j.mcswiggan@dundee.ac.uk
    Scientific contact
    McSwiggan, University of Dundee, 01382 383233, s.j.mcswiggan@dundee.ac.uk
    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 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    26 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary research objective is to test if allopurinol can reduce thickening of the heart muscle in patients with treated high blood pressure.
    Protection of trial subjects
    Safety bloods taken at every study visit MRI safety check list completed to ensure safety/suitability for cardiac MRI Urine pregnancy testing for female patients of child bearing potential Recording/reporting of adverse events
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Aug 2014
    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
    United Kingdom: 72
    Worldwide total number of subjects
    72
    EEA total number of subjects
    72
    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)
    22
    From 65 to 84 years
    48
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment 30/9/14 - 6/6/16. All recruited in Scotland.

    Pre-assignment
    Screening details
    		 200 were excluded 123 no echocardiographic LVH 53 uncontrolled hypertension 7 poor echo quality 7 contraindications to MRI 3 Gout 1 not hypertensive 1 change in BP medications <3 months 1 severe aortic stenosis 1 taking theophylline 1 active cancer treatment 1 atrial fibrillation 1 decided not to participate (issues with insurance)

    Pre-assignment period milestones
    Number of subjects started
    		 72
    Number of subjects completed
    		 72

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo Group
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Microcrystalline cellulose Ph Eur
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule daily for one month (+/- one week) increased to one capsule twice daily for 11 months (+/- 2 weeks).

    Arm title
    		 Intervention Group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Allopurinol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    300mg daily for one month (+/- one week), then 300mg twice daily for 11 months (+/- 2 weeks).

    Number of subjects in period 1
    		Placebo Group Intervention Group
    Started
    36
    36
    Completed
    30
    32
    Not completed
    6
    4
         Adverse event non fatal/Consent withdrawn
    6
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo Group
    Reporting group description
    		 -

    Reporting group title
    Intervention Group
    Reporting group description
    		 -

    Reporting group values
    		 Placebo Group Intervention Group Total
    Number of subjects
    		 36 36 72
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 12 10 22
        From 65-84 years
    		 23 25 48
        85 years and over
    		 1 1 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.6 ( 10.4 ) 66.8 ( 9.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 16 16 32
        Male
    		 20 20 40
    IHD
    Units: Subjects
        Yes
    		 0 2 2
        No
    		 36 34 70
    Dyslipidaemia
    Units: Subjects
        Yes
    		 14 15 29
        No
    		 22 21 43
    TIA/CVA
    Units: Subjects
        Yes
    		 4 4 8
        No
    		 32 32 64
    DM
    Units: Subjects
        Yes
    		 3 1 4
        No
    		 33 35 68
    PVD
    Units: Subjects
        Yes
    		 1 0 1
        No
    		 35 36 71
    Smoker
    Units: Subjects
        Yes
    		 3 1 4
        No
    		 33 35 68
    Ex-smoker
    Units: Subjects
        Yes
    		 14 16 30
        No
    		 22 20 42
    ACE-I
    Units: Subjects
        Yes
    		 18 14 32
        No
    		 18 22 40
    B-Blocker
    Units: Subjects
        Yes
    		 8 13 21
        No
    		 28 23 51
    Calcium Channel Blocker
    Units: Subjects
        Yes
    		 26 22 48
        No
    		 10 14 24
    a-blocker
    Units: Subjects
        Yes
    		 7 9 16
        No
    		 29 27 56
    Thiazide Diuretic
    Units: Subjects
        Yes
    		 16 11 27
        No
    		 20 25 45
    Loop Diuretic
    Units: Subjects
        Yes
    		 4 2 6
        No
    		 32 34 66
    Mineralocorticoid receptor antagonist
    Units: Subjects
        Yes
    		 3 2 5
        No
    		 33 34 67
    Angiotensin Receptor Blocker
    Units: Subjects
        Yes
    		 12 17 29
        No
    		 24 19 43
    Centrally Acting Anti-hypertensive
    Units: Subjects
        Yes
    		 1 1 2
        No
    		 35 35 70
    Renin Blocker
    Units: Subjects
        Yes
    		 1 0 1
        No
    		 35 36 71
    Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 30.9 ( 5.1 ) 30.4 ( 5.3 ) -
    Daytime Average Systolic BP
    Units: mmHg
        arithmetic mean (standard deviation)
    		 125.6 ( 7.4 ) 124.3 ( 8.8 ) -
    Daytime Average Diastolic BP
    Units: mmHg
        arithmetic mean (standard deviation)
    		 74.5 ( 7.2 ) 72.9 ( 9.6 ) -
    Haemoglobin
    Units: g/L
        arithmetic mean (standard deviation)
    		 138.9 ( 12.2 ) 139.75 ( 14.0 ) -
    Creatinine
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 73.7 ( 10.8 ) 67.5 ( 15.7 ) -
    Glucose
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 5.39 ( 0.81 ) 5.77 ( 0.95 ) -
    Urate
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 374.3 ( 85.6 ) 347.3 ( 108.3 ) -
    Hs-CRP
    Units: mg/L
        arithmetic mean (standard deviation)
    		 2.34 ( 3.40 ) 2.14 ( 2.88 ) -
    TBARs
    Units: uM
        arithmetic mean (standard deviation)
    		 3.01 ( 1.01 ) 2.81 ( 0.88 ) -
    NTproBNP
    Units: pg/mL
        arithmetic mean (standard deviation)
    		 657.59 ( 696.49 ) 897.73 ( 1048.96 ) -
    PICP
    Units: ng/L
        arithmetic mean (standard deviation)
    		 1.74 ( 0.99 ) 1.50 ( 0.70 ) -
    Soluble ST2
    Units: ng/mL
        arithmetic mean (standard deviation)
    		 19.56 ( 7.76 ) 19.76 ( 10.98 ) -
    Echo LV Mass
    Units: gram(s)
        arithmetic mean (standard deviation)
    		 245.0 ( 59.0 ) 244.7 ( 57.2 ) -
    Echo LV Mass Index
    Units: g/m2
        arithmetic mean (standard deviation)
    		 124.7 ( 20.4 ) 123.3 ( 16.3 ) -
    MRI LV Mass
    Units: gram(s)
        arithmetic mean (standard deviation)
    		 130.56 ( 36.26 ) 125.86 ( 38.86 ) -
    MRI LV Mass Height 1.7
    Units: g/m1.7
        arithmetic mean (standard deviation)
    		 53.9 ( 11.9 ) 51.0 ( 11.8 ) -
    MRI EDV
    Units: mL
        arithmetic mean (standard deviation)
    		 142.16 ( 35.82 ) 140.97 ( 31.77 ) -
    MRI ESV
    Units: mL
        arithmetic mean (standard deviation)
    		 36.94 ( 17.60 ) 36.71 ( 13.29 ) -
    MRI SV
    Units: ml
        arithmetic mean (standard deviation)
    		 105.22 ( 22.08 ) 104.26 ( 21.82 ) -
    MRI Ejection Fraction
    Units: percent
        arithmetic mean (standard deviation)
    		 75.0 ( 7.0 ) 74.5 ( 5.6 ) -
    FMD
    Flow Mediated Dilation
    Units: percent
        arithmetic mean (standard deviation)
    		 5.4 ( 4.4 ) 5.9 ( 3.7 ) -
    AIx
    Augmentation Index
    Units: percent
        arithmetic mean (standard deviation)
    		 20.4 ( 13.7 ) 24.8 ( 14.2 ) -
    PWV
    Pulse Wave Velocity
    Units: m/s
        arithmetic mean (standard deviation)
    		 8.18 ( 1.05 ) 8.49 ( 1.28 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo Group
    Reporting group description
    		 -

    Reporting group title
    Intervention Group
    Reporting group description
    		 -

    Primary: To assess the effect of Allopurinol compared to placebo on change in MRI LV mass

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on change in MRI LV mass
    End point description
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    32
    Units: g/m1.7
        arithmetic mean (standard deviation)
    -1.60 ( 1.60 )
    -0.18 ( 2.39 )
    Statistical analysis title
    		 Independent T test
    Comparison groups
    Placebo Group v Intervention Group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on on change in MRI LV mass

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on on change in MRI LV mass
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    32
    Units: grams
        arithmetic mean (standard deviation)
    -3.75 ( 3.89 )
    -0.37 ( 6.08 )
    Statistical analysis title
    		 Independant T Test
    Comparison groups
    Placebo Group v Intervention Group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on on change in MRI LV end-diastolic volume.

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on on change in MRI LV end-diastolic volume.
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    32
    Units: ml
        arithmetic mean (standard deviation)
    2.32 ( 18.26 )
    6.47 ( 16.35 )
    Statistical analysis title
    		 Independent T test
    Comparison groups
    Placebo Group v Intervention Group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.349
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on on change in MRI LV end-systolic volume

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on on change in MRI LV end-systolic volume
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    32
    Units: ml
        arithmetic mean (standard deviation)
    -1.02 ( 10.64 )
    1.59 ( 10.28 )
    Statistical analysis title
    		 Independent T test
    Comparison groups
    Placebo Group v Intervention Group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.331
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on on change in MRI LV stroke volume

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on on change in MRI LV stroke volume
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    32
    Units: ml
        arithmetic mean (standard deviation)
    3.34 ( 10.90 )
    4.88 ( 10.84 )
    Statistical analysis title
    		 Independent T test
    Comparison groups
    Intervention Group v Placebo Group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.579
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on change in MRI LV ejection fraction

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on change in MRI LV ejection fraction
    End point description
    End point type
    Secondary
    End point timeframe
    12 Months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    32
    Units: percent
        arithmetic mean (standard deviation)
    1.03 ( 4.99 )
    0.25 ( 5.49 )
    Statistical analysis title
    		 Independant t test
    Comparison groups
    Placebo Group v Intervention Group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.561
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on change in MRI LA End-diastolic volume

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on change in MRI LA End-diastolic volume
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    26
    29
    Units: ml
        arithmetic mean (standard deviation)
    3.81 ( 8.86 )
    2.57 ( 8.68 )
    Statistical analysis title
    		 Independent T test
    Comparison groups
    Intervention Group v Placebo Group
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.605
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on change in MRI LA End-systolic volume

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on change in MRI LA End-systolic volume
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    26
    29
    Units: ml
        arithmetic mean (standard deviation)
    2.88 ( 5.04 )
    2.32 ( 6.78 )
    Statistical analysis title
    		 Independent T test
    Comparison groups
    Placebo Group v Intervention Group
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.73
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on change in MRI LA stroke volume

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on change in MRI LA stroke volume
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    26
    29
    Units: ml
        arithmetic mean (standard deviation)
    0.93 ( 6.82 )
    0.26 ( 8.23 )
    Statistical analysis title
    		 Independent T test
    Comparison groups
    Placebo Group v Intervention Group
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.746
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on change in MRI LA ejection fraction

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on change in MRI LA ejection fraction
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    32
    Units: percent
        arithmetic mean (standard deviation)
    -1.36 ( 4.93 )
    -1.07 ( 5.88 )
    Statistical analysis title
    		 Independant t test
    Comparison groups
    Placebo Group v Intervention Group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.849
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on change in daytime systolic blood pressure

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on change in daytime systolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    32
    Units: mmHg
        arithmetic mean (standard deviation)
    1.6 ( 7.3 )
    -0.9 ( 8.0 )
    Statistical analysis title
    		 Independent T test
    Comparison groups
    Intervention Group v Placebo Group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.205
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on change in daytime diastolic blood pressure

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on change in daytime diastolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    32
    Units: mmHg
        arithmetic mean (standard deviation)
    0.1 ( 5.4 )
    0.3 ( 5.7 )
    Statistical analysis title
    		 Independent T test
    Comparison groups
    Placebo Group v Intervention Group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.846
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on change in Flow mediated dilation (FMD)

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on change in Flow mediated dilation (FMD)
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    29
    Units: percent
        arithmetic mean (standard deviation)
    -0.23 ( 3.65 )
    0.14 ( 4.12 )
    Statistical analysis title
    		 Independent T Test
    Comparison groups
    Placebo Group v Intervention Group
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.718
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on change in Augmentation index (AIx)

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on change in Augmentation index (AIx)
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    31
    Units: percent
        arithmetic mean (standard deviation)
    -0.30 ( 13.46 )
    0.06 ( 12.41 )
    Statistical analysis title
    		 Independent T Test
    Comparison groups
    Intervention Group v Placebo Group
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.913
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on change in Pulse wave velocity (PWV)

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on change in Pulse wave velocity (PWV)
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    29
    Units: measure
        arithmetic mean (standard deviation)
    -0.09 ( 1.12 )
    -0.25 ( 1.07 )
    Statistical analysis title
    		 Independent T Test
    Comparison groups
    Placebo Group v Intervention Group
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.581
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on change in Urate

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on change in Urate
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    32
    Units: umol/L
        arithmetic mean (standard deviation)
    -1.33 ( 37.04 )
    -189.56 ( 91.95 )
    Statistical analysis title
    		 Independent T test
    Comparison groups
    Placebo Group v Intervention Group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on change in High sensitivity C-Reactive Protein (HsCRP)

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on change in High sensitivity C-Reactive Protein (HsCRP)
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    31
    Units: mg/L
        arithmetic mean (standard deviation)
    -0.55 ( 2.10 )
    0.22 ( 1.71 )
    Statistical analysis title
    		 Independent T test
    Comparison groups
    Intervention Group v Placebo Group
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.122
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on change in Thiobarbituric acid reactive substances (TBARs)

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on change in Thiobarbituric acid reactive substances (TBARs)
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    31
    Units: uM
        arithmetic mean (standard deviation)
    -0.34 ( 0.83 )
    0.26 ( 0.85 )
    Statistical analysis title
    		 Independent T test
    Comparison groups
    Placebo Group v Intervention Group
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on change in N-terminalprohormone B-Type Natriuretic Peptide (NT-proBNP)

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on change in N-terminalprohormone B-Type Natriuretic Peptide (NT-proBNP)
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    31
    Units: pg/mL
        arithmetic mean (standard deviation)
    109.08 ( 491.03 )
    -109.03 ( 612.84 )
    Statistical analysis title
    		 Independent T test
    Comparison groups
    Placebo Group v Intervention Group
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.131
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on change in Procollagen type I carboxy-terminal Propeptide (PICP)

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on change in Procollagen type I carboxy-terminal Propeptide (PICP)
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    31
    Units: ng/L
        arithmetic mean (standard deviation)
    -0.18 ( 0.60 )
    -0.05 ( 0.43 )
    Statistical analysis title
    		 Independent T test
    Comparison groups
    Placebo Group v Intervention Group
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.322
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: To assess the effect of Allopurinol compared to placebo on change in Soluble ST2 (sST2)

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    End point title
    		 To assess the effect of Allopurinol compared to placebo on change in Soluble ST2 (sST2)
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo Group Intervention Group
    Number of subjects analysed
    30
    31
    Units: ng/ml
        arithmetic mean (standard deviation)
    -1.02 ( 3.39 )
    -0.61 ( 8.63 )
    Statistical analysis title
    		 Independent T test
    Comparison groups
    Placebo Group v Intervention Group
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.573
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAE), serious adverse reactions (SAR) and suspected unexpected serious adverse reaction (SUSAR) were reported to TASC pharmacovigilance section within twenty-four hours.
    Adverse event reporting additional description
    Adverse events reporting was carried out in accordance with TASC SOP 11 (identifying, recording and reporting adverse events for clinical trials of IMP). At each study adverse events were assessed and recorded in the CRF or when alerted by subjects.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Allopurinol
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Allopurinol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 36 (5.56%)
    1 / 36 (2.78%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Procedural intestinal perforation
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (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
    		 Placebo Allopurinol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 36 (77.78%)
    29 / 36 (80.56%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 36 (8.33%)
    1 / 36 (2.78%)
         occurrences all number
    3
    1
    Orthostatic hypotension
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Cholecystectomy
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Skin lesion removal
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    4 / 36 (11.11%)
    2 / 36 (5.56%)
         occurrences all number
    4
    2
    Oedema peripheral
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    1
    2
    Malaise
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Peripheral swelling
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Uterine polyp
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Wheezing
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Pleurisy
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Depression
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Post traumatic stress disorder
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Investigations
    Weight increased
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Animal bite
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    2 / 36 (5.56%)
    1 / 36 (2.78%)
         occurrences all number
    2
    2
    Atrial fibrillation
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    4 / 36 (11.11%)
    4 / 36 (11.11%)
         occurrences all number
    4
    4
    Headache
         subjects affected / exposed
    1 / 36 (2.78%)
    4 / 36 (11.11%)
         occurrences all number
    2
    5
    Paraesthesia
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Sciatica
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Dysgeusia
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Somnolence
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Syncope
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Pancytopenia
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Diplopia
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    4 / 36 (11.11%)
    5 / 36 (13.89%)
         occurrences all number
    4
    5
    Dyspepsia
         subjects affected / exposed
    4 / 36 (11.11%)
    5 / 36 (13.89%)
         occurrences all number
    4
    5
    Nausea
         subjects affected / exposed
    1 / 36 (2.78%)
    2 / 36 (5.56%)
         occurrences all number
    1
    4
    Rectal haemorrhage
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Pruritus
         subjects affected / exposed
    1 / 36 (2.78%)
    3 / 36 (8.33%)
         occurrences all number
    1
    3
    Rash
         subjects affected / exposed
    1 / 36 (2.78%)
    3 / 36 (8.33%)
         occurrences all number
    3
    4
    Blister
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Pain of skin
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Nocturia
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Urinary incontinence
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Chronic kidney disease
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 36 (11.11%)
    4 / 36 (11.11%)
         occurrences all number
    4
    4
    Back pain
         subjects affected / exposed
    2 / 36 (5.56%)
    2 / 36 (5.56%)
         occurrences all number
    3
    2
    Myalgia
         subjects affected / exposed
    2 / 36 (5.56%)
    1 / 36 (2.78%)
         occurrences all number
    2
    3
    Muscle spasms
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 36 (5.56%)
    2 / 36 (5.56%)
         occurrences all number
    2
    2
    Urinary tract infection
         subjects affected / exposed
    3 / 36 (8.33%)
    0 / 36 (0.00%)
         occurrences all number
    3
    0
    Fungal infection
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Herpes zoster
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Decreased appetite
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Hyponatraemia
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Oct 2014
    AM01 1. Change in placebo from lactose to microcrytalline cellulose 2. Secondary Objective/Outcome measures changed  3. Typo's and other minor corrections/clarifications to protocol 4. Alterations to patient information sheet (PIS)
    07 Apr 2015
    AM02 1. Change in exclusion criteria 2. Addition of a recruitment source 3. Corrections/clarifications 4. Alterations in patient information sheet

    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
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