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    Clinical Trial Results:
    Diuretic Treatment in Acute Heart Failure with Volume Overload Guided by Serial Spot Urine Sodium Assessment

    Summary
    EudraCT number
    		 2021-005426-18
    Trial protocol
    		 BE  
    Global end of trial date
    01 Jul 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jul 2025
    First version publication date
    19 Jul 2025
    Other versions
    Summary report(s)
    		 Results DECONGEST

    Trial information

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    Trial identification
    Sponsor protocol code
    DECONGEST_v1.3
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05411991
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital Brussels
    Sponsor organisation address
    Laarbeeklaan 101, Jette, Belgium, 1090
    Public contact
    Centrum voor Hart- en Vaatziekten, UZ Brussel, +32 24774111,
    Scientific contact
    Centrum voor Hart- en Vaatziekten, UZ Brussel, +32 24774111,
    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 Sep 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jul 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate whether a diuretic regimen with low-treshold use of combination diuretic therapy, based on serial assessment of sodium concentration on spot urine samples after diuretic administration, improves decongestion in AHF.
    Protection of trial subjects
    Anticipated adverse events, potentially related to the study intervention, include arterial hypotension, acute kidney injury (AKI) and electrolyte disorders. Arterial blood pressure is evaluated throughout the study protocol with continuous invasive measurements or frequent non invasive assessment by cuff manometry. Serum creatinine, eGFR, and serum electro-lyte levels are followed on a daily base during the administration of intravenous diuretics ac-cording to the study protocol and afterwards at the discretion of the treating physician. Prespecified safety protocols were in place for such events.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Dec 2022
    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: 107
    Worldwide total number of subjects
    107
    EEA total number of subjects
    107
    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)
    11
    From 65 to 84 years
    62
    85 years and over
    34

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 107
    Number of subjects completed
    		 104

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Adverse event, non-fatal: 1
    Reason: Number of subjects
    		 Consent withdrawn by subject: 2
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard of care
    Arm description
    		 -
    Arm type
    		 Standard of care arm

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Intervention arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Burinex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Dose depending on the eGFR: 2 mg for >45 mL/min/1.73m²; 3 mg for 45 30 mL/min/1.73m²; or 4 mg for <30 mL/min/1.73m²

    Investigational medicinal product name
    Diamox
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    500 mg OD

    Number of subjects in period 1 [1]
    		Standard of care Intervention arm
    Started
    52
    52
    Completed
    47
    49
    Not completed
    5
    3
         Adverse event, serious fatal
    4
    3
         Consent withdrawn by subject
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Two subjects withdrew consent before receiving any study intervention. One underwent urgent CABG before receiving any study intervention. Those subjects were excluded from the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard of care
    Reporting group description
    		 -

    Reporting group title
    Intervention arm
    Reporting group description
    		 -

    Reporting group values
    		 Standard of care Intervention arm Total
    Number of subjects
    		 52 52 104
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 79 ( 10 ) 81 ( 10 ) -
    Gender categorical
    Units: Subjects
        Female
    		 24 21 45
        Male
    		 28 31 59
    NTproBNP
    Units: ng/L
        median (inter-quartile range (Q1-Q3))
    		 4989 (2523 to 9014) 4134 (2423 to 7920) -

    End points

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    End points reporting groups
    Reporting group title
    Standard of care
    Reporting group description
    		 -

    Reporting group title
    Intervention arm
    Reporting group description
    		 -

    Subject analysis set title
    Main analysis
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized patients that received at least one dose of diuretics according to the study protocol. Patients are analysed according to the treatment group they were allocated to according to the electronic randomization system (irrespective of the actual treatment received).

    Primary: Net treatment benefit for hierarchical composite endpoint

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    End point title
    		 Net treatment benefit for hierarchical composite endpoint
    End point description
    Net treatment benefit for the hierarchical composite primary endpoint: 1. 30-day survival 2. Days alive & out of hospital or care facility up to 30 days 3. Relative decrease in NTproBNP from baseline
    End point type
    Primary
    End point timeframe
    30 days
    End point values
    		 Standard of care Intervention arm Main analysis
    Number of subjects analysed
    51
    52
    103
    Units: Percentage of wins
        number (not applicable)
    44.16
    54.68
    103
    Statistical analysis title
    		 Generalized pairwaise comparison
    Comparison groups
    Standard of care v Intervention arm
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.357
    Method
    		 Generalized pairwise comparison
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    30 days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Standard of care
    Reporting group description
    		 -

    Reporting group title
    Intervention arm
    Reporting group description
    		 -

    Serious adverse events
    		 Standard of care Intervention arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 51 (35.29%)
    9 / 52 (17.31%)
         number of deaths (all causes)
    4
    3
         number of deaths resulting from adverse events
    Cardiac disorders
    Death
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 51 (7.84%)
    3 / 52 (5.77%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    Vasopressive therapy
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardioversion
    Additional description: Urgent
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    worsening heart failure
    Additional description: administration of intravenous diuretics or intensification of oral diuretics leading to hospital admission or urgent evaluation
         subjects affected / exposed
    7 / 51 (13.73%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    3 / 51 (5.88%)
    2 / 52 (3.85%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hypocalcaemia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Endocarditis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Standard of care Intervention arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 51 (41.18%)
    13 / 52 (25.00%)
    Renal and urinary disorders
    Hypokalaemia
         subjects affected / exposed
    21 / 51 (41.18%)
    13 / 52 (25.00%)
         occurrences all number
    21
    13

    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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