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    Clinical Trial Results:
    Effect of phosphodiesterase-5 inhibition with Tadalafil on SystEmic Right VEntricular size and function – a multi-center, double-blind, randomized, placebo-controlled clinical trial – SERVE Trial

    Summary
    EudraCT number
    		 2016-004291-21
    Trial protocol
    		 AT  
    Global end of trial date
    28 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions
    Summary report(s)
    		 SERVE-Manuscript-Publication
    SERVE Final Report Synopsis
    SERVE-SAPV1

    Trial information

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    Trial identification
    Sponsor protocol code
    SERVE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03049540
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Insel Nr: 3330, KOFAM: SNCTP000002130
    Sponsors
    Sponsor organisation name
    Insel Gruppe AG
    Sponsor organisation address
    Freiburgstrasse, Bern, Switzerland, 3010
    Public contact
    Prof. Dr. Markus Schwerzmann, Inselspital Zentrum für angeborene Herzfehler, +41 31632 00 99, markus.schwerzmann@insel.ch
    Scientific contact
    Prof. Dr. Markus Schwerzmann, Inselspital Zentrum für angeborene Herzfehler, +41 31632 00 99, markus.schwerzmann@insel.ch
    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
    18 Oct 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Oct 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study assesses in a double-blind, randomized, placebo-controlled multi-center pilot trial the effect of PDE-5 inhibition with Tadalafil on right ventricle (RV) size and functionin adults with a systemic RV over a 3-year follow-up period.
    Protection of trial subjects
    Regular followup, Data Safety Monitoring Board (trial with approved drug / placebo but outside indication)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2017
    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
    Austria: 12
    Country: Number of subjects enrolled
    Switzerland: 88
    Worldwide total number of subjects
    100
    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)
    98
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period: FPFV: 17/11/2017/ LPLV: 28/10/2021 CH and AU. For further details see main manuscript

    Pre-assignment
    Screening details
    		 See main manuscript

    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, Assessor
    Blinding implementation details
    Tadalafil 20 mg p.o. OD for 3 years vs. placebo p.o. OD . The study medication was provided in blinded manner.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment Arm
    Arm description
    		 Tadalafil 20 mg p.o. OD for 3 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tadalafil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tadalafil 20 mg p.o. OD for 3 years

    Arm title
    		 Placebo Arm
    Arm description
    		 Placebo p.o. OD for 3 years
    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 p.o. OD for 3 years

    Number of subjects in period 1
    		Treatment Arm Placebo Arm
    Started
    51
    49
    Completed
    42
    41
    Not completed
    9
    8
         Adverse event, serious fatal
    1
    1
         Consent withdrawn by subject
    8
    4
         Lost to follow-up
    -
    2
         Protocol deviation
    -
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Treatment Arm
    Reporting group description
    		 Tadalafil 20 mg p.o. OD for 3 years

    Reporting group title
    Placebo Arm
    Reporting group description
    		 Placebo p.o. OD for 3 years

    Primary: mean RV-ESV change during follow-up

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    End point title
    		 mean RV-ESV change during follow-up [1]
    End point description
    End point type
    Primary
    End point timeframe
    3 years
    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: See Statistical Analysis Plan and Manuscript attached for statistical analyses
    End point values
    		 Treatment Arm Placebo Arm
    Number of subjects analysed
    45
    46
    Units: ml
        RV-ESV change
    3
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Events as defined per protocol needed to be reported from ICF signature until last follow-up visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Frequency threshold for reporting non-serious adverse events: 1%
    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: See manuscript for Adverse Event listing as attached

    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
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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
    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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