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    Clinical Trial Results:
    Cardiac and renal interactions during the treatment of decompensated heart failure: diuretics versus ultrafiltration (CRUF Trial)

    Summary
    EudraCT number
    		 2009-017589-22
    Trial protocol
    		 BE  
    Global end of trial date
    21 Oct 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jul 2021
    First version publication date
    30 Jul 2021
    Other versions
    Summary report(s)
    		 Statement of discontinuation

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2009/013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    Corneel Heymanslaan 10, Ghent, Belgium, 9000
    Public contact
    Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    Scientific contact
    Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    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
    21 Oct 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Oct 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Oct 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To understand cardiorenal interactions when treated with ultrafiltration versus diuretics for decompensated heart failure to better select patients who will benefit from ultrafiltration in the future. To determine if there are differences in: a. Influence on renal congestion of diuretics versus ultrafiltration; intra-abdominal pressure as a parameter of renal congestion, b. Influence of diuretics versus ultrafiltration on plasma refill rate: plasma hematocrit as a measure of dilution c. Influence of diuretics versus ultrafiltration on echocardiographic filling parameters and hydration state via bioelectrical impedance. d. Influence on urinary potassium/sodium excretion with diuretics versus ultrafiltration. e. Impact on a new renal biomarker: urinary and plasma NGAL (vs creatinine, cystatin C, measured urinary creat clearance) for detection acute renal insufficiency when administering diuretics versus ultrafiltration.
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Apr 2010
    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
    Belgium: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    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)
    0
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 1 patient was screened in the period from 15-04-2010 till 21-10-2011. 1 patient was enrolled in the diuretics group. Due to limitations of the system, the number of patients that entered ultrafiltration group was defined as 1, the number of completion as 0. End of Trial notification was dated 21/10/2011 and submitted to EC and CA 21/10/2011.

    Pre-assignment
    Screening details
    		 Inclusion criteria: Severe systolic heart failure, ejection fraction < 40% and admission with acute decompensated heart failure: NYHA class III-IV + 1 of the following: Vena Jugularis distension >6cm - Diastolic function echo: E/E'medial >15, lateral>12 - RX thorax: pulmonary edema-pleural fluid. Minimum 18 years of age

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 ultrafiltration group
    Arm description
    		 No patients were enrolled in the ultrafiltration group. Due to technical limitations of the system the number of subjects that started this arm was defined as 1 and the number of patients that completed the arm was defined as 0. Procedure: Ultrafiltration through double lumen catheter, via central vein.
    Arm type
    		 procedure

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 diuretics group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bumetanide
    Investigational medicinal product code
    CAS 28395031
    Other name
    Burinex
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Maximum duration of treatment of a subject: 72 hours Maximum dose allowed: Dose per day, 1 mg/h milligram(s)/hour

    Number of subjects in period 1
    		ultrafiltration group diuretics group
    Started
    1
    1
    Completed
    0
    1
    Not completed
    1
    0
         No patients were enrolled in this study arm.
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ultrafiltration group
    Reporting group description
    		 No patients were enrolled in the ultrafiltration group. Due to technical limitations of the system the number of subjects that started this arm was defined as 1 and the number of patients that completed the arm was defined as 0. Procedure: Ultrafiltration through double lumen catheter, via central vein.

    Reporting group title
    diuretics group
    Reporting group description
    		 -

    Reporting group values
    		 ultrafiltration group diuretics group Total
    Number of subjects
    		 1 1 1
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 1 1 1
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 1 1 1

    End points

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    End points reporting groups
    Reporting group title
    ultrafiltration group
    Reporting group description
    		 No patients were enrolled in the ultrafiltration group. Due to technical limitations of the system the number of subjects that started this arm was defined as 1 and the number of patients that completed the arm was defined as 0. Procedure: Ultrafiltration through double lumen catheter, via central vein.

    Reporting group title
    diuretics group
    Reporting group description
    		 -

    Primary: Incidence of AKI and determining factors in patients with acute decompensated heart failure with treated with ultrafiltration versus diuretics

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    End point title
    		 Incidence of AKI and determining factors in patients with acute decompensated heart failure with treated with ultrafiltration versus diuretics [1]
    End point description
    End point type
    Primary
    End point timeframe
    At 6 months
    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 statistical analysis available.
    End point values
    		 ultrafiltration group diuretics group
    Number of subjects analysed
    0 [2]
    1
    Units: probability
        number (not applicable)
    0
    Notes
    [2] - No patients were enrolled in this group.
    No statistical analyses for this end point

    Secondary: Combined endpoint of mortality/rehospitalisation-urgent outpatient visit due to heart failure

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    End point title
    		 Combined endpoint of mortality/rehospitalisation-urgent outpatient visit due to heart failure
    End point description
    End point type
    Secondary
    End point timeframe
    At 6 months
    End point values
    		 ultrafiltration group diuretics group
    Number of subjects analysed
    0 [3]
    1
    Units: N/A
    0
    Notes
    [3] - No patients were enrolled in this group.
    No statistical analyses for this end point

    Secondary: Determination of the value of Neutrophil gelatinase-associated lipocalin (NGAL) to predict AKI in acute decompensated heart failure (vs creatinine, Cystatin C,measured urinary creatinine clearance) in patients treated with diuretics vs ultrafiltration.

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    End point title
    		 Determination of the value of Neutrophil gelatinase-associated lipocalin (NGAL) to predict AKI in acute decompensated heart failure (vs creatinine, Cystatin C,measured urinary creatinine clearance) in patients treated with diuretics vs ultrafiltration.
    End point description
    End point type
    Secondary
    End point timeframe
    At 48h after treatment start
    End point values
    		 ultrafiltration group diuretics group
    Number of subjects analysed
    0 [4]
    1
    Units: NGAL value
        number (not applicable)
    0
    Notes
    [4] - No patients were enrolled in this group.
    No statistical analyses for this end point

    Secondary: Kidney function measured by creatinine

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    End point title
    		 Kidney function measured by creatinine
    End point description
    End point type
    Secondary
    End point timeframe
    After 28 days and 6 months
    End point values
    		 ultrafiltration group diuretics group
    Number of subjects analysed
    0 [5]
    1
    Units: creatinine
        number (not applicable)
    0
    Notes
    [5] - No patients were enrolled in this group.
    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
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    diuretics group
    Reporting group description
    		 -

    Serious adverse events
    		 diuretics group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 diuretics group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    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: No non-serious adverse events were recorded for the participating patients.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 May 2010
    Reasons for the substantial amendment: changes in interpretation of scientific documents/value of the trial, changes in conduct or management of the trial. Reasons for substantial amendment: Amendment of an inclusion criterion Brief description of the changes: Change of one inclusion criterion: age minimum 18 years instead of patients between 18 and 75 years

    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.
    Given the poor inclusion, the study was discontinued.
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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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