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    Clinical Trial Results:
    Safety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology

    Summary
    EudraCT number
    2006-004705-26
    Trial protocol
    GB  
    Global end of trial date
    27 Feb 2009

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Jun 2020
    First version publication date
    06 Jun 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CRO529
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensington Campus, London, United Kingdom, SW7 2AZ
    Public contact
    PROFESSOR MICHAEL GATZOULIS, Imperial College London, +44 (0)20 7352 8121, m.gatzoulis@imperial.ac.uk
    Scientific contact
    PROFESSOR MICHAEL GATZOULIS, Imperial College London, +44 (0)20 7352 8121, m.gatzoulis@imperial.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 Feb 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Feb 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Feb 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To examine safety and tolerability of oral sildenafil in patients with Eisenmenger physiology. Primary endpoint: Effects of sildenafil on systemic oxygen saturation in patients with pulmonary arterial hypertension related to Eisenmenger physiology
    Protection of trial subjects
    None
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Apr 2008
    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: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients with Eisenmenger physiology (non-restrictive intra- or extra-cardiac communication with a right-to-left shunt at rest), in New York Heart Association (NYHA) class III and followed at a single tertiary center were recruited. Twelve patients with Eisenmenger physiology were recruited between April 2008 and February 2009.

    Pre-assignment
    Screening details
    All participants were admitted to the hospital for 2 days at the start of the study. Baseline assessment consisted of a QoL questionnaire, transthoracic echocardiogram, six-minute walk test (6MWT) and blood test.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Open-label study

    Arms
    Arm title
    all patients
    Arm description
    All participants received Sildenafil for 3 months.
    Arm type
    Experimental

    Investigational medicinal product name
    Sildenafil
    Investigational medicinal product code
    Other name
    Revatio ® 20 mg film-coated tablets
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg three times daily for 3 months

    Number of subjects in period 1
    all patients
    Started
    12
    Completed
    12

    Baseline characteristics

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

    Reporting group values
    Overall Total
    Number of subjects
    12 12
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    12 12
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    34.3 ± 10.2 -
    Gender categorical
    Units: Subjects
        Female
    10 10
        Male
    2 2

    End points

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    End points reporting groups
    Reporting group title
    all patients
    Reporting group description
    All participants received Sildenafil for 3 months.

    Subject analysis set title
    Baseline
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Baseline data of the participants

    Primary: Oxygen saturation

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    End point title
    Oxygen saturation
    End point description
    End point type
    Primary
    End point timeframe
    3 months
    End point values
    all patients Baseline
    Number of subjects analysed
    12
    12
    Units: percent
        arithmetic mean (standard deviation)
    82.6 ± 11
    83.8 ± 3.8
    Statistical analysis title
    Oxigen saturation
    Statistical analysis description
    Baseline compare to 3 months
    Comparison groups
    all patients v Baseline
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.76
    Method
    Fisher exact
    Confidence interval

    Secondary: Camphor scores Symptoms

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    End point title
    Camphor scores Symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    all patients Baseline
    Number of subjects analysed
    12
    12
    Units: scores
        arithmetic mean (standard deviation)
    5.3 ± 3.6
    11 ± 2.7
    Statistical analysis title
    Symptome scores
    Statistical analysis description
    Compare baseline to 3 months
    Comparison groups
    all patients v Baseline
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    3 months
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    all patients
    Reporting group description
    All participants received Sildenafil for 3 months.

    Serious adverse events
    all patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 12 (16.67%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Transient asymptomic hypotension
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    all patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 12 (91.67%)
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 12 (41.67%)
         occurrences all number
    5
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    4 / 12 (33.33%)
         occurrences all number
    4

    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/20304507
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