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    Clinical Trial Results:
    The effect of spironolactone on renal hemodynamics in patients with essential hypertension

    Summary
    EudraCT number
    		 2019-001636-60
    Trial protocol
    		 DK  
    Global end of trial date
    09 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Sep 2022
    First version publication date
    03 Sep 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SL-3-2019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Clinic in Nephrology and Hypertension
    Sponsor organisation address
    Hospitalsparken 15, Herning, Denmark, 7400
    Public contact
    Stine Sundgaard Langaa, University clinic of Nephrology and Hypertension, Gødstrup Hospital, 0045 60125230, stinlg@rm.dk
    Scientific contact
    Jesper Nørgaard Bech, University clinic of Nephrology and Hypertension, Gødstrup Hospital, 0045 78436587, jesper.noergaard.bech@vest.rm.dk
    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
    12 Apr 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jun 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jun 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate the effect af treatment with spironolactone for 4 weeks renal hemodynamics in patients with essentiel hypertension
    Protection of trial subjects
    Initiation of blood pressure medication (metoprololsuccinate), if ambulatory blood pressure measured approximately 2 weeks after cessation of antihypertensiva exceeded 150/95. Blood test approx. 2 weeks into each 4-week treatment period
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Sep 2019
    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
    Denmark: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    7
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited by advertisement in the local newspaper

    Pre-assignment
    Screening details
    		 Hypertensive patients, male and female, age 40-80 years, eGFR > 60 ml/min, Urine Albumine < 700 mg/L

    Period 1
    Period 1 title
    Treatment period 1
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Spironolactone
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Spironolactone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    The study was a cross-over study. The study subjects received spironolactone 50 mg or placebo for two 4-week treatment periods in random order. The treatment periods were separated by a washout period lasting at least 1 week.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    The study was a cross-over study. The study subjects received spironolactone 50 mg or placebo for two 4-week treatment periods in random order. The treatment periods were separated by a washout period lasting at least 1 week.

    Number of subjects in period 1
    		Spironolactone Placebo
    Started
    8
    8
    Completed
    5
    5
    Not completed
    3
    3
         Covid-19 pandemic
    3
    2
         Malignancy suspicion
    -
    1
    Period 2
    Period 2 title
    Treatment period 2
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Spironolactone
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Spironolactone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    The study was a cross-over study. The study subjects received spironolactone 50 mg or placebo for two 4-week treatment periods in random order. The treatment periods were separated by a washout period lasting at least 1 week.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    The study was a cross-over study. The study subjects received spironolactone 50 mg or placebo for two 4-week treatment periods in random order. The treatment periods were separated by a washout period lasting at least 1 week.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: The study is a cross-over study. Only data from the 10 subjects who completed both treatment periods are analyzed. Baseline characteristics includes the ten completing subjects.
    Number of subjects in period 2 [2]
    		Spironolactone Placebo
    Started
    5
    5
    Completed
    5
    5
    Notes
    [2] - 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: The study is a cross-over study. Only data from the 10 subjtects who completed both treatment periods are analyzed. Baseline characteristics includes the ten completing subjects.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period 2
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period 2 Total
    Number of subjects
    		 10 10
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 5 5
        From 65-84 years
    		 5 5
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 7 7

    End points

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    End points reporting groups
    Reporting group title
    Spironolactone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -
    Reporting group title
    Spironolactone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Rubidium-82 clearance

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    End point title
    		 Rubidium-82 clearance [1]
    End point description
    The end point is reported for both treatment periods
    End point type
    Primary
    End point timeframe
    End of study
    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: Data is presented as mean +/- standard deviation
    End point values
    		 Spironolactone Placebo Spironolactone Placebo
    Number of subjects analysed
    5
    5
    5
    5
    Units: ml/min/1.73 m2
        arithmetic mean (standard deviation)
    421 ± 94
    453 ± 136
    418 ± 120
    439 ± 96
    No statistical analyses for this end point

    Secondary: MAG-3 clearance

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    End point title
    		 MAG-3 clearance
    End point description
    The end point is reported for both treatment periods
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 Spironolactone Placebo Spironolactone Placebo
    Number of subjects analysed
    5
    5
    5
    5
    Units: ml/min/1.73 m2
        arithmetic mean (standard deviation)
    208 ± 46
    210 ± 40
    203 ± 25
    221 ± 65
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From day 1 in teatment period 1 until 1 week after the end of treatment period 2
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Serious adverse events
    		 Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 16 (18.75%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Headache
    Additional description: Admitted with neckpain, headache, vomiting. Blood pressure is high at admissiontime. Paracetamol relieves pain and blood pressure falls spontaneously
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Transitory ischemic attack
    Additional description: Admitted due to visionloss on one eye lasting 5 minutes. CT cerebrum and CT angiograhy of arteries in neck without infarction and stenosis respectively.
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Bile duct/pancreatic disease
    Additional description: Admitted with fever, jaundice, pruritus. Conclusion of examinations: possible malignancy in the pancreas
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 16 (62.50%)
    Vascular disorders
    Superficial thrombophlebitis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 16 (37.50%)
         occurrences all number
    6
    Gastrointestinal disorders
    Loose stools
    Additional description: Loose stools in a short period during the study
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    3
    Vomiting and nausea
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Renal and urinary disorders
    Finding of renal cyst on PET/CT
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    3
    Infections and infestations
    Fungus in groin
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    3
    Dental infection
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    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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