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    Clinical Trial Results:
    Effects of Aldosterone Antagonism in Heart Failure with Preserved Ejection Fraction (HF-PEF): Cardiac MRI, Echocardiography, Exercise Physiology & Quality of Life Assessment

    Summary
    EudraCT number
    		 2013-000867-10
    Trial protocol
    		 GB  
    Global end of trial date
    27 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Sep 2019
    First version publication date
    05 Sep 2019
    Other versions
    Summary report(s)
    		 HF-PEF JAHA final
    HF-PEF tables final

    Trial information

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    Trial identification
    Sponsor protocol code
    CD13/10671
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1145-4102
    Sponsors
    Sponsor organisation name
    University of Leeds
    Sponsor organisation address
    Leeds, Leeds, United Kingdom, LS2 9JT
    Public contact
    A K McDiarmid, University of Leeds, a.k.mcdiarmid@leeds.ac.uk
    Scientific contact
    A K McDiarmid, University of Leeds, a.k.mcdiarmid@leeds.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
    01 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jul 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To define mechanisms for effect of Aldosterone antagonism in the treatment of heart failure with preserved ejection fraction (HF-PEF) using cardiac magnetic resonance imaging.
    Protection of trial subjects
    An independent Trial Steering Committee assisted the CI and the research team to ensure trial participants were protected from harm.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2013
    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: 51
    Worldwide total number of subjects
    51
    EEA total number of subjects
    51
    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)
    3
    From 65 to 84 years
    45
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adults aged 18-90 with a clinical diagnosis of HF-PEF according to 2012 European Society of Cardiology (ESC)(1) criteria under the care of the local heart failure service (Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom) were eligible to participate in the study. Recruitment took place between 04/06/2014 and 06/12/2016.

    Pre-assignment
    Screening details
    		 Inclusion criteria: NYHA class II-IV, physical signs consistent with heart failure, LVEF on clinical echocardiography >50% and NT-proBNP >400pg/L at routine clinic attendance.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 spironolactone
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    spironolactone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg od.

    Arm title
    		 no treatment
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		spironolactone no treatment
    Started
    27
    24
    Completed
    19
    21
    Not completed
    8
    3
         Physician decision
    3
    -
         Consent withdrawn by subject
    1
    3
         inability to tolerate CMR
    1
    -
         Protocol deviation
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    spironolactone
    Reporting group description
    		 -

    Reporting group title
    no treatment
    Reporting group description
    		 -

    Reporting group values
    		 spironolactone no treatment Total
    Number of subjects
    		 27 24 51
    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)
    		 76.4 ± 5.4 74.0 ± 8.8 -
    Gender categorical
    Units: Subjects
        Female
    		 14 13 27
        Male
    		 13 11 24

    End points

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    End points reporting groups
    Reporting group title
    spironolactone
    Reporting group description
    		 -

    Reporting group title
    no treatment
    Reporting group description
    		 -

    Primary: Change in myocardial extracellular volume (ECV) fraction by cardiovascular magnetic resonance (CMR) as a surrogate of diffuse fibrosis.

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    End point title
    		 Change in myocardial extracellular volume (ECV) fraction by cardiovascular magnetic resonance (CMR) as a surrogate of diffuse fibrosis. [1]
    End point description
    End point type
    Primary
    End point timeframe
    after 6 months of treatment/no intervention
    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: Please see the results paper which has been uploaded and contains details of the statistical analysis.
    End point values
    		 spironolactone no treatment
    Number of subjects analysed
    19
    21
    Units: percent volume/volume
        number (not applicable)
    -1.0
    0.8
    Attachments
    		 HF-PEF tables final
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    overall study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 per study protocol
    Dictionary version
    2.5
    Reporting groups
    Reporting group title
    spironolactone
    Reporting group description
    		 -

    Reporting group title
    no treatment
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no non-serious adverse events in this study.
    Serious adverse events
    		 spironolactone no treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 27 (11.11%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Renal and urinary disorders
    Renal failure
    Additional description: Impairment of renal function
         subjects affected / exposed
    3 / 27 (11.11%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 spironolactone no treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 24 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Aug 2014
    Substantial Amendment 1: Changes were made to the protocol and patient documentation to provide greater clarity around the prescription of the IMP and around additional visits for the participants. These changes were suggested following an early internal monitoring visit and after discussion with the Chief Investigator.
    25 Feb 2016
    Substantial Amendment 2: A notification of serious breach of GCP or the trial protocol was submitted to the competent authority. The sponsor and the research team were of the opinion that no further patients should be approached and recruited until appropriate changes have been made to the study protocol. These are changes surrounding the management of study visits.
    06 Apr 2016
    The changes were made to provide greater clarity around the blood tests and around additional visits for the participants. Time windows were added to the visit schedule. We implemented these changes due to repeated problems with getting the blood tests performed in a timely manner in the community. We requested to restart the trial which had been temporarily halted on 25/02/2016.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    25 Feb 2016
    As described in amendment 2, the trial was halted whilst new safety measures surrounding blood testing were put in place.
    23 Mar 2016

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