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    Clinical Trial Results:
    Randomized study on the hemodynamic effect of the association of simvastatin with non-cardioselective beta-blockers in patients with liver cirrhosis and clinically significant portal hypertension.

    Summary
    EudraCT number
    		 2010-022516-39
    Trial protocol
    		 ES  
    Global end of trial date
    04 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jul 2022
    First version publication date
    09 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SIMBETA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau – IIB Sant Pau
    Sponsor organisation address
    c/ Sant Quintí, 77-79 , BARCELONA, Spain, 08041
    Public contact
    UICEC Sant Pau, Institut de Recerca Hospital de la Santa Creu i Sant Pau, 0034 935537636, uicec@santpau.cat
    Scientific contact
    UICEC Sant Pau, Institut de Recerca Hospital de la Santa Creu i Sant Pau, 0034 935537636, uicec@santpau.cat
    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
    17 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective will be to assess whether, in patients with compensated cirrhosis, portal hypertension greater than 10mmHg and esophageal varices at risk, the association of a selective hepatic vasodilator such as simvastatin together with non-cardioselective beta-blockers may have any long-term hemodynamic effect.
    Protection of trial subjects
    The study will be conducted in strict accordance with international ethical recommendations for research and clinical trials in humans. Likewise, the standards contained in the Declaration of Helsinki will be guaranteed and will be developed in accordance with the protocol and with the standard work procedures (SOPs) that ensure compliance with the standards of Good Clinical Practice (PCB). The investigator should explain to the patient (when possible) or his authorized legal representative, the nature of the study, its purposes, procedures, estimated duration, the potential risks and benefits related to the participation in the study, as well as any inconvenience that this may cause. can suppose. Each of the participants should be warned that their participation in the study is voluntary and that they can leave the study at any time, without this affecting their subsequent treatment or their relationship with the professionals who treat them. For this, an information / consent sheet has been designed for the patient or the authorized legal representative, which is attached.
    Background therapy
    		 Carvedilol (Cv), a non-selective β-blockers (NSBBs) with capacity to ameliorate hepatic vascular resistance (HVR), is more effective than traditional-NSBBs to reduce the hepatic venous pressure gradient (HVPG). Statins may also decrease portal hypertension by reducing the HVR by improving endothelial function. Whether the addition of statins may improve the hemodynamic effects of carvedilol in cirrhosis with clinically significant portal hypertension (CSPH) has not been clarified. This study aimed to evaluate whether the addition of simvastatin (Sv) can improve the hemodynamic effects of carvedilol in cirrhosis with CSPH and without previous HVPG response to NSBBs.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Oct 2011
    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
    Spain: 82
    Worldwide total number of subjects
    82
    EEA total number of subjects
    82
    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)
    82
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients of both sexes, with liver cirrhosis, older than 18 years and younger than 80 years who meet all the inclusion criteria and do not meet any exclusion criteria.

    Pre-assignment
    Screening details
    		 - Liver cirrhosis diagnosed by previous biopsy or by clinical, analytical and ultrasound criteria. -PPG >10 mmHg. -Presence of large esophageal varices or small esophageal varices with red dots, esophageal varices of any size and Pugh C, and/or fundic gastric varices of any size, in a recent gastroscopy (< 1 month)

    Period 1
    Period 1 title
    BASELINE (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CARVEDILOL + PLACEBO
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    CARVEDILOL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    6.25 mg/ 24h

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    XXXXX

    Arm title
    		 CARVEDILOL + SIMVASTATINA
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    CARVEDILOL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    6.25 mg/ 24

    Investigational medicinal product name
    SIMVASTATINA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg/ 24h

    Number of subjects in period 1
    		CARVEDILOL + PLACEBO CARVEDILOL + SIMVASTATINA
    Started
    41
    41
    INICIAL
    41
    41
    Completed
    41
    41

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    CARVEDILOL + PLACEBO
    Reporting group description
    		 -

    Reporting group title
    CARVEDILOL + SIMVASTATINA
    Reporting group description
    		 -

    Primary: hepatic venous pressure gradient

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    End point title
    		 hepatic venous pressure gradient
    End point description
    End point type
    Primary
    End point timeframe
    OVERALL PERIOD
    End point values
    		 CARVEDILOL + PLACEBO CARVEDILOL + SIMVASTATINA
    Number of subjects analysed
    41
    41
    Units: mmHg
    2
    3
    Statistical analysis title
    		 Descriptive statistical analysis
    Comparison groups
    CARVEDILOL + PLACEBO v CARVEDILOL + SIMVASTATINA
    Number of subjects included in analysis
    82
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    CARVEDILOL + PLACEBO
    Reporting group description
    		 -

    Reporting group title
    CARVEDILOL + SIMVASTATINA
    Reporting group description
    		 -

    Serious adverse events
    		 CARVEDILOL + PLACEBO CARVEDILOL + SIMVASTATINA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CARVEDILOL + PLACEBO CARVEDILOL + SIMVASTATINA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 41 (21.95%)
    11 / 41 (26.83%)
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 41 (4.88%)
         occurrences all number
    1
    2
    Hypotension
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    0
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    8 / 41 (19.51%)
    4 / 41 (9.76%)
         occurrences all number
    8
    4
    Hepatobiliary disorders
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Increase of Creatin Kinase
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1

    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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