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    Clinical Trial Results:
    A multicenter, Double-blind, RandOmised, two arm Parallel group trial to determine the effects of torasemide versus furosemide on one marker (PIP) of cardiac fibrosis in patient with Diastolic Heart Failure and diabetes mellitus type II

    Summary
    EudraCT number
    		 2013-003601-25
    Trial protocol
    		 DE  
    Global end of trial date
    20 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Mar 2022
    First version publication date
    17 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DROP-PIP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité - Universitätsmedizin Berlin
    Sponsor organisation address
    Augustenburger Platz 1, Berlin, Germany, Augustenburger Platz
    Public contact
    Prof. Dr. Carsten Tschöpe, Charité Universitätsmedizin Berlin, 49 30450 553712, Carsten.Tschoepe@charite.de
    Scientific contact
    Prof. Dr. Carsten Tschöpe, Charité Universitätsmedizin Berlin, 49 30450 553712, Carsten.Tschoepe@charite.de
    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
    20 Sep 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial is to determine whether torasemide is superior to furosemide in reducing one marker (PIP) of cardiac fibrosis in subjects with diastolic heart failure and diabetes type II.
    Protection of trial subjects
    Qualified personnel monitored the trial, performed off- and on-site visits and assured scientific integrity. A control contact by phone after 44 days, a control visit after 5 months, a final visit for blinded PIP measurements, and secondary endpoint assessment after 9 months. For safety, we followed up the patients 2 weeks after the final visit.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Dec 2013
    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
    Germany: 35
    Worldwide total number of subjects
    35
    EEA total number of subjects
    35
    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
    35
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patient enrollment started 1 October 2014 and ended by 21 December 2015. Consecutive, eligible subjects meeting inclusion/exclusion criteria were considered for the study. The investigators verified that patients met all inclusion. Patients with PIP measurements >=110 ng/mL or >=70 ng/mL with LAVI .29 mL/m2 at screening were eligible for randomis

    Pre-assignment
    Screening details
    		 A total of 214 patients were pre-screened, 51.4% declined to participate in DROP-PIP. Out of the 104 patients undergoing full screening, 14% had elevated PIP levels (≥110 ng/mL), and 54% of patients showed abnormal serum PIP levels in the grey zone of <110 ng/mL and ≥70 ng/mL.

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor
    Blinding implementation details
    Patients, the investigator team, individuals performing the assessments, and data analysts remained blinded to the identity of treatment until after database lock;

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Furosemide Group
    Arm description
    		 Patients were supplied with the drug at specified visits during the treatment period and received sufficient supply of the study drug to last until their next scheduled visit.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Furosemid
    Investigational medicinal product code
    Furosemid
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    furosemide 20 mg: Patients were supplied with the drug at specified visits during the treatment period and received sufficient supply of the study drug to last until their next scheduled visit.

    Arm title
    		 Torasemide Group
    Arm description
    		 The investigators dispensed the study drug to the subject after the appropriate treatment allocated for the subject via randomisation and according to the protocol.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Torasemid
    Investigational medicinal product code
    Torasemid
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5mg Torasemide Patients were supplied with the drug at specified visits during the treatment period and received sufficient supply of the study drug to last until their next scheduled visit.

    Number of subjects in period 1
    		Furosemide Group Torasemide Group
    Started
    18
    17
    Completed
    16
    12
    Not completed
    2
    5
         Adverse event, serious fatal
    1
    -
         Lost to follow-up
    -
    1
         Protocol deviation
    1
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Furosemide Group
    Reporting group description
    		 Patients were supplied with the drug at specified visits during the treatment period and received sufficient supply of the study drug to last until their next scheduled visit.

    Reporting group title
    Torasemide Group
    Reporting group description
    		 The investigators dispensed the study drug to the subject after the appropriate treatment allocated for the subject via randomisation and according to the protocol.

    Reporting group values
    		 Furosemide Group Torasemide Group Total
    Number of subjects
    		 18 17 35
    Age categorical
    Units: Subjects
        Adults ≥18 years
    		 18 17 35
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 69.3 ( 8.1 ) 68.0 ( 8.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 4 15
        Male
    		 7 13 20
    Peripheral oedema
    Units: Subjects
        Peripheral oedema (yes)
    		 17 15 32
        Peripheral oedema (No)
    		 1 2 3
    Pulmonary congestions
    Units: Subjects
        Pulmonary congestions (yes)
    		 5 3 8
        Pulmonary congestions (no)
    		 13 14 27
    New York Heart Association
    NYHA
    Units: Subjects
        class I
    		 4 2 6
        class II
    		 6 10 16
        class III
    		 8 5 13
    Heart rate
    Units: b.p.m
        arithmetic mean (standard deviation)
    		 74.8 ( 19.2 ) 72.3 ( 15.5 ) -
    Systolic BP
    Units: mmHg
        arithmetic mean (standard deviation)
    		 136.8 ( 19.2 ) 130.2 ( 17.2 ) -
    Diastolic BP
    Units: mmHg
        arithmetic mean (standard deviation)
    		 76.8 ( 9.9 ) 74.0 ( 12.3 ) -
    Body mass index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 34.8 ( 6.3 ) 34.5 ( 6.7 ) -
    Respiratory rate
    Units: /min
        arithmetic mean (standard deviation)
    		 17.1 ( 1.8 ) 17.2 ( 1.4 ) -
    Cardiac structure and function LVEF
    left ventricular ejection fraction (LVEF)
    Units: LVEF (%)
        arithmetic mean (standard deviation)
    		 62.5 ( 6.5 ) 61.0 ( 9.0 ) -
    Cardiac structure and function LVMI
    Left ventricular mass index LVMI
    Units: LVMI (g/m²)
        arithmetic mean (standard deviation)
    		 116.1 ( 26.6 ) 129.6 ( 27.3 ) -
    Cardiac structure and function LVEDVI
    left ventricular end diastolic ventricular volume index
    Units: LVEDVI (mL/m²)
        arithmetic mean (standard deviation)
    		 51.1 ( 14.0 ) 53.7 ( 18.4 ) -
    Cardiac structure and function LAVI
    left atrial volume index LAVI
    Units: LAVI (mL/m2)
        arithmetic mean (standard deviation)
    		 37.8 ( 8.9 ) 42.7 ( 14.4 ) -
    Cardiac structure and function E wave
    Units: m/s
        arithmetic mean (standard deviation)
    		 79.6 ( 19.5 ) 87.5 ( 20.8 ) -
    Cardiac structure and function Deceleration time
    Units: time (ms)
        arithmetic mean (standard deviation)
    		 231.4 ( 74.8 ) 235.5 ( 59.9 ) -
    Cardiac structure and function 6MWT
    6-minute walk test
    Units: distance (m)
        arithmetic mean (standard deviation)
    		 409.2 ( 110.2 ) 434.4 ( 127.6 ) -
    Laboratory PIP
    C-terminal propeptide of procollagen type I
    Units: ng/mL
        arithmetic mean (standard deviation)
    		 133.1 ( 50.5 ) 99.7 ( 29.3 ) -
    Laboratory Sodium
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 141.8 ( 2.9 ) 141.1 ( 2.0 ) -
    Potassium
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 4.4 ( 0.4 ) 4.3 ( 0.5 ) -
    Laboratory Creatinine
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 1.00 ( 0.3 ) 1.0 ( 0.2 ) -
    Laboratory eGFR
    eGFR: estimated glomerular filtration using the Modification of Diet in Renal Disease formula
    Units: mL/min
        arithmetic mean (standard deviation)
    		 70.7 ( 18.7 ) 73.5 ( 15.9 ) -
    Laboratory NT-proBNP
    NT-proBNP: N-terminal pro-B-type natriuretic peptide
    Units: pg/mL
        arithmetic mean (standard deviation)
    		 148.2 ( 141.4 ) 201.8 ( 175.9 ) -
    Quality of life KCCQ total symptom
    Kansas City Cardiomyopathy Questionnaire
    Units: score
        arithmetic mean (standard deviation)
    		 62.7 ( 28.7 ) 59.3 ( 26.6 ) -
    Quality of life KCCQ clinical summary
    Kansas City Cardiomyopathy Questionnaire
    Units: Score
        arithmetic mean (standard deviation)
    		 62.9 ( 31.3 ) 58.1 ( 27.1 ) -
    Quality of life KCCQ overall summary
    Kansas City Cardiomyopathy Questionnaire
    Units: Score
        arithmetic mean (standard deviation)
    		 61.5 ( 28.3 ) 56.6 ( 27.9 ) -

    End points

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    End points reporting groups
    Reporting group title
    Furosemide Group
    Reporting group description
    		 Patients were supplied with the drug at specified visits during the treatment period and received sufficient supply of the study drug to last until their next scheduled visit.

    Reporting group title
    Torasemide Group
    Reporting group description
    		 The investigators dispensed the study drug to the subject after the appropriate treatment allocated for the subject via randomisation and according to the protocol.

    Subject analysis set title
    furosemide (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Primary and secondary outcomes were analysed in the per-protocol population.

    Subject analysis set title
    torasemide (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Primary and secondary outcomes were analysed in the per-protocol population.

    Subject analysis set title
    Diff (F–T) ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    difference between Furosemide and Torasemide

    Subject analysis set title
    Diff (F-T) PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    difference between Furosemide and Torasemide in the per protocol group analysis

    Primary: Change of the PIP value PP

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    End point title
    		 Change of the PIP value PP
    End point description
    End point type
    Primary
    End point timeframe
    9 months
    End point values
    		 furosemide (PP) torasemide (PP) Diff (F-T) PP
    Number of subjects analysed
    16
    12
    28
    Units: ng/ml
    arithmetic mean (standard deviation)
        Percentage PIP change
    3.08 ( 29.30 )
    3.72 ( 28.17 )
    -064 ( 28.83 )
        Absolute PIP change
    1.15 ( 38.11 )
    -1.25 ( 29.10 )
    2.40 ( 34.59 )
    Statistical analysis title
    		 change of the percentage in PIP values in PP
    Comparison groups
    furosemide (PP) v torasemide (PP)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.27
         upper limit
    		 21.99
    Statistical analysis title
    		 change of the absolute values of PIP in PP
    Comparison groups
    torasemide (PP) v furosemide (PP)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.75
         upper limit
    		 29.55

    Secondary: Change of the Cardiac structure and function LVMI

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    End point title
    		 Change of the Cardiac structure and function LVMI
    End point description
    LVMI, left ventricular mass index
    End point type
    Secondary
    End point timeframe
    9 months
    End point values
    		 furosemide (PP) torasemide (PP)
    Number of subjects analysed
    16
    12
    Units: g/m²
    arithmetic mean (full range (min-max))
        LVMI (g/m2)
    -24.065546 (-83.80 to 30.20)
    -8.930035 (-50.00 to 23.00)
    No statistical analyses for this end point

    Secondary: Change of the Cardiac structure and function LVEDVI and LAVI

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    End point title
    		 Change of the Cardiac structure and function LVEDVI and LAVI
    End point description
    LAVI, left atrial volume index; LVEDVI, left ventricular end-diastolic volume index;
    End point type
    Secondary
    End point timeframe
    9 months
    End point values
    		 furosemide (PP) torasemide (PP)
    Number of subjects analysed
    16
    12
    Units: mL/m2
    arithmetic mean (full range (min-max))
        LVEDVI
    -1.369978 (-32.80 to 11.00)
    8.974017 (-15.00 to 100.00)
        LAVI
    11.845524 (-22.00 to 28.00)
    -4.433040 (-25.80 to 17.00)
    No statistical analyses for this end point

    Secondary: Change of the Cardiac structure and function E-wave

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    End point title
    		 Change of the Cardiac structure and function E-wave
    End point description
    End point type
    Secondary
    End point timeframe
    9 months
    End point values
    		 furosemide (PP) torasemide (PP)
    Number of subjects analysed
    16
    12
    Units: m/s
    arithmetic mean (full range (min-max))
        E wave
    3.227311 (-19.20 to 43.00)
    -0.925811 (-33.00 to 22.40)
    No statistical analyses for this end point

    Secondary: Change of the Cardiac structure and function Deceleration

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    End point title
    		 Change of the Cardiac structure and function Deceleration
    End point description
    End point type
    Secondary
    End point timeframe
    9 months
    End point values
    		 furosemide (PP) torasemide (PP)
    Number of subjects analysed
    16
    12
    Units: time in ms
    arithmetic mean (full range (min-max))
        Deceleration time
    -0.149871 (-12.00 to 10.00)
    -4.746263 (-29.00 to 7.00)
    No statistical analyses for this end point

    Secondary: Change of the Cardiac structure and function in 6MWT

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    End point title
    		 Change of the Cardiac structure and function in 6MWT
    End point description
    End point type
    Secondary
    End point timeframe
    9 months
    End point values
    		 furosemide (PP) torasemide (PP)
    Number of subjects analysed
    16
    12
    Units: distance in m
    arithmetic mean (full range (min-max))
        6MWT distance
    -24.065546 (-83.80 to 30.20)
    -8.930035 (-50.00 to 23.00)
    No statistical analyses for this end point

    Secondary: Laboratory change in Sodium and Potassium

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    End point title
    		 Laboratory change in Sodium and Potassium
    End point description
    End point type
    Secondary
    End point timeframe
    9 months
    End point values
    		 furosemide (PP) torasemide (PP)
    Number of subjects analysed
    16
    12
    Units: mmol/L
    arithmetic mean (full range (min-max))
        Sodium
    0.848150 (-5.00 to 4.00)
    1.051091 (-3.00 to 5.00)
        Potassium
    0.146975 (-0.50 to 1.10)
    -0.103028 (-1.00 to 0.50)
    Attachments
    		 Graphical display of safety parameters
    No statistical analyses for this end point

    Secondary: Laboratory Change in Creatinine

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    End point title
    		 Laboratory Change in Creatinine
    End point description
    End point type
    Secondary
    End point timeframe
    9months
    End point values
    		 furosemide (PP) torasemide (PP)
    Number of subjects analysed
    16
    12
    Units: mg/dL
        arithmetic mean (full range (min-max))
    0.051509 (-0.26 to 0.60)
    0.002024 (-0.32 to 0.38)
    No statistical analyses for this end point

    Secondary: Laboratory Change in NTproBNP

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    End point title
    		 Laboratory Change in NTproBNP
    End point description
    NT-proBNP, N-terminal pro-B-type natriuretic peptide
    End point type
    Secondary
    End point timeframe
    9 months
    End point values
    		 furosemide (PP) torasemide (PP)
    Number of subjects analysed
    16
    12
    Units: pg/mL
    arithmetic mean (full range (min-max))
        NT-proBNP
    100.427856 (-64.60 to 696.50)
    19.663125 (-115.50 to 476.30)
    No statistical analyses for this end point

    Secondary: Change in Quality of life (KCCQ)

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    End point title
    		 Change in Quality of life (KCCQ)
    End point description
    Kansas City Cardiomyopathy Questionnaire
    End point type
    Secondary
    End point timeframe
    9 months
    End point values
    		 furosemide (PP) torasemide (PP)
    Number of subjects analysed
    16
    12
    Units: Score
    arithmetic mean (full range (min-max))
        KCCQ total symptom
    1.844597 (-25.00 to 41.67)
    2.262459 (-25.00 to 33.33)
        KCCQ clinical summary
    1.168577 (-19.79 to 36.77)
    3.951155 (-15.63 to 31.25)
        KCCQ overall summary
    3.560723 (-16.93 to 27.08)
    -0.038717 (-18.75 to 27.08)
    No statistical analyses for this end point

    Other pre-specified: Difference between Furosemide and Torasemide in ITT Group

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    End point title
    		 Difference between Furosemide and Torasemide in ITT Group
    End point description
    End point type
    Other pre-specified
    End point timeframe
    9 months
    End point values
    		 Diff (F–T) ITT
    Number of subjects analysed
    35
    Units: ng/ml
    arithmetic mean (standard deviation)
        Percentage PIP change
    0.11 ( 25.63 )
        Absolute PIP change
    1.90 ( 30.70 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    9 months
    Adverse event reporting additional description
    One non-cardiac death with no relation to the study drug or procedures was observed in the furosemide group. Overall, 17.1% of patients dropped out due to other causes, mainly refractory congestion requiring intensified therapy outside of the protocol
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 own
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Furosemide
    Reporting group description
    		 -

    Reporting group title
    Torasemide
    Reporting group description
    		 -

    Serious adverse events
    		 Furosemide Torasemide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 18 (61.11%)
    11 / 17 (64.71%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    fracture, surgery, depression, pulmonary infection
         subjects affected / exposed
    5 / 18 (27.78%)
    4 / 17 (23.53%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    refractory congestion, cardiac decompensation
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 17 (11.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    acute coronary syndrome, atrial flutter/fibrillation
         subjects affected / exposed
    3 / 18 (16.67%)
    3 / 17 (17.65%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    anuresis, acute renal failure
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Furosemide Torasemide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 18 (83.33%)
    10 / 17 (58.82%)
    Investigations
    Hyperkalaemia (>5.2 mmol/L)
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 17 (17.65%)
         occurrences all number
    1
    3
    Hypotension (≤100 mmHg systolic blood pressure)
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 17 (11.76%)
         occurrences all number
    1
    2
    Injury, poisoning and procedural complications
    Falls
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 17 (5.88%)
         occurrences all number
    2
    1
    Gastrointestinal disorders
    Refractory congestion
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 17 (5.88%)
         occurrences all number
    2
    1
    Renal and urinary disorders
    Worsening renal function (> 0.3mg/dL increase in Creatinine)
         subjects affected / exposed
    9 / 18 (50.00%)
    3 / 17 (17.65%)
         occurrences all number
    9
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Apr 2014
    #1 Amendment: Update protocol V1.3. from 2013/08/07 Modul 1
    02 Mar 2015
    #2 Amendment: Update study protocol + Synopse V1.3
    24 Aug 2015
    #3 Amendment: Update study protocol V1.4 from 2015/ 08/06, update Modul 1
    05 Apr 2016
    #4 Amendment: Change manufacturer of study medication., update Modul 1 - IMPD, SmPC

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28891228
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