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    Clinical Trial Results:
    Perhexiline therapy in patients with heart failure with preserved left ventricular ejection fraction(HFpEF syndrome)

    Summary
    EudraCT number
    		 2006-001109-28
    Trial protocol
    		 GB  
    Global end of trial date
    03 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Aug 2018
    First version publication date
    18 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    pgrf/141/09
    Additional study identifiers
    ISRCTN number
    		 ISRCTN25678870
    US NCT number
    		 NCT00839228
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Aberdeen
    Sponsor organisation address
    Research Governance, Foresterhill House Annexe, Aberdeen, United Kingdom, AB25 2ZB
    Public contact
    Michael P Frenneaux, University of Aberdeen, 0121 4146926, M.P.Frenneaux@bham.ac.uk
    Scientific contact
    Michael P Frenneaux, University of Aberdeen, 0121 4146926, M.P.Frenneaux@bham.ac.uk
    Sponsor organisation name
    NHS Grampian
    Sponsor organisation address
    R&D Office, Foresterhill House Annexe, Aberdeen, United Kingdom, AB25 2ZB
    Public contact
    Professor Frenneaux, NHS Grampian Health Board, 0121 4146926, M.P.Frenneaux@bham.ac.uk
    Scientific contact
    Professor Frenneaux, NHS Grampian Health Board, 0121 4146926, M.P.Frenneaux@bham.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 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To test whether perhexiline improve exercise capacity (peak vo2) in patients with heart failure with preserved left ventricular ejection fraction(HFpEFsyndrome)
    Protection of trial subjects
    A total of 72 patients who meet the selection criteria will be recruited from NHS Grampian and University Hospitals Birmingham NHS trust. Informed consent will be obtained from each patient.
    Background therapy
    		 We postulate that perhexiline-induced shifts in metabolism will lead to improved cardiac energetic, exercise capacity, quality of like and myocardial function in HFpEF patients.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2011
    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
    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)
    19
    From 65 to 84 years
    51
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 72 patients who meet the selection criteria will be recruited from NHS Grampian and University Hospitals Birmingham NHS trust.

    Pre-assignment
    Screening details
    		 Clinical symptoms and signs consistent with HF; LVEF >50%, with no evidence of significant valvular disease, no hypertrophic cardiomyopathy and no evidence of pericardial constriction; A peak VO2 <80% predicted, with RER >1 and with a pattern of gas exchange on metabolic exercise testing indicating a cardiac cause for limitation; All patient recrui

    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, Carer

    Arms
    Arm title
    		 Perhexiline vs Placebo
    Arm description
    		 Perhexiline 100mg o bd for 3 months
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Perhexiline Maleate
    Investigational medicinal product code
    021418
    Other name
    PEXSIG
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Diameter 8.5mm. Each tablet contains 100mg Perhexiline Maleate (100mg o bd 3 months)

    Number of subjects in period 1
    		Perhexiline vs Placebo
    Started
    72
    Completed
    72

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 72 72
    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)
    		 19 19
        From 65-84 years
    		 51 51
        85 years and over
    		 2 2
    Gender categorical
    Units: Subjects
        Female
    		 48 48
        Male
    		 24 24

    End points

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    End points reporting groups
    Reporting group title
    Perhexiline vs Placebo
    Reporting group description
    		 Perhexiline 100mg o bd for 3 months

    Primary: Peak oxygen consumption (Vo2max)

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    End point title
    		 Peak oxygen consumption (Vo2max) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Not documented.
    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: No publication has been submitted to date therefore unable to specify statistical analysis.
    End point values
    		 Perhexiline vs Placebo
    Number of subjects analysed
    72
    Units: carbon dioxide re-breathing
        number (not applicable)
    72
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All SAEs will be reported to the sponsor and PI within 1 working day of discovery or notification of the event. All AEs occurring during the study observed by the investigator or reported by the patient will be reported on the CRF.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Perhexiline vs Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Perhexiline vs Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Muskuloskeletal Chest Pain
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Pancreatic cancer
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Perhexiline vs Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 5 (40.00%)
    Surgical and medical procedures
    Knee Replacement
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Spinal Surgery
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jun 2012
    AM05 - Addition of BNP tests at baseline and post exercise.

    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
    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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