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    Summary
    EudraCT Number:2017-001679-22
    Sponsor's Protocol Code Number:EMPA-UMCG-1
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-09-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-001679-22
    A.3Full title of the trial
    Randomized, double blind, placebo controlled, multicenter pilot study on the effects of empagliflozin on clinical outcomes in patients with acute decompensated heart failure
    Gerandomiseerde, dubbel blinde, placebo gecontrolleerde, multicenter pilot studie naar het effect van empagliflozine op klinische uitkomst in patienten met acuut hartfalen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, double blind, placebo controlled study on the effect of the SGLT2 inhibitor (a new class of anti-diabetics with diuretic effects) Empagliflozin in patients admitted with acute decompensated heart failure
    A.3.2Name or abbreviated title of the trial where available
    EMPA-RESPONSE-AHF
    A.4.1Sponsor's protocol code numberEMPA-UMCG-1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniveristy Medical Center Groningen
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBoehringer Ingelheim
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031503616161
    B.5.6E-mailk.damman@umcg.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Empagliflozin (Jardiance)
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEmpagliflozin
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute (decompensated) heart failure
    acuut hartfalen
    E.1.1.1Medical condition in easily understood language
    Situation of decreased pumping capacity of the heart resulting in symptoms and signs of fluid retention, dyspnea and acute admission to hospital
    Situatie van verminderde pompfunctie van het hart met als consequentie vocht vasthouden, kortademigheid en acute opname in het ziekenhuis
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10019280
    E.1.2Term Heart failures
    E.1.2System Organ Class 100000004849
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10019283
    E.1.2Term Heart failure signs and symptoms
    E.1.2System Organ Class 100000004908
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000803
    E.1.2Term Acute heart failure
    E.1.2System Organ Class 100000011689
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to evaluate whether empagliflozin 10mg/day will relieve dyspnea, improves diuretic response, decreases length of initial hospital stay and NT-proBNP compared to placebo during hospital admission for acute decompensated heart failure.
    Het primary doel van deze studie is het onderzoeken of Empagliflozine 10 mg/dag dyspnoe verbetert, diuretische response verbetert, ziekenhuisopname verkort en NTproBNP levels verlaagd vergeleken met placebo tijdens opname voor acuut hartfalen
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are to evaluate the effects of empagliflozin on change in dyspnea, renal function, and NT-proBNP and on 30-day death and/or heart failure hospital.
    Secundaire doelen zijn het onderzoeken van het effect van Empagliflozine op verandering in dyspnoe, nierfunctie, NTproBNP en 30 dagen mortaliteit en hartfalen heropnames
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female >18 years of age;
    2. Hospitalized for AHF; AHF is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening:
    a. Dyspnea at rest or with minimal exertion
    b. Signs of congestion, such as edema, rales, and/or congestion on chest radiograph
    c. BNP ≥350 pg/mL or NT-proBNP ≥1,400 pg/mL (for patients with AF: BNP≥500 pg/mL or NT-proBNP ≥2,000 pg/mL)
    d. Treated with loop diuretics at screening
    3. Able to be randomized within 24 hours from presentation to the hospital
    4. Able and willing to provide freely given written informed consent
    5. eGFR (CKD-EPI) ≥30 ml/min/1.73m2 between presentation and randomization
    1. Mannen of Vrouwen > 18 jaar.
    2. Opname voor Acuut Hartfalen gedefinieerd als:
    - Dyspnoe in rust of bij minimale inspanning
    - Tekenen van congestie
    - BNP ≥350 pg/mL of NT-proBNP ≥1,400 pg/mL (bij atriumfibrilleren: BNP≥500 pg/mL or NT-proBNP ≥2,000 pg/mL)
    - Behandeling met lisdiuretica op screening
    3) Randomisatie binnen 24 uur mogelijk
    4) Informed consent
    5) eGFR > 30 ml/min/1.73 m2
    E.4Principal exclusion criteria
    1. Dyspnea primarily due to non-cardiac causes
    2. Cardiogenic shock
    3. Acute coronary syndrome within 30 days prior to randomization
    4. Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization
    3. Signs of keto-acidosis and/or hyperosmolar hyperglaecemic syndrome (pH>7.30 and glucose >15 mmol/L and HCO3>18 mmol/L)
    4. Pregnant or nursing (lactating) women
    5. Current participation in any interventional study
    6. Inability to follow instructions or comply with follow-up procedures
    7. Any other medical conditions that may put the patient at risk or influence study results in the investigator’s opinion, or that the investigator deems unsuitable for the study.
    1) Dyspnoe door niet cardiale oorzaken
    2) Cardiogene shock
    3) Acute coronaire syndromen binnen 30 dagen voor randomisatie
    4) Geplande coronaire interventie
    5) Tekenen van Keto-Acidose en/of hyperosomolair hyperglycemisch syndroom
    6) Zwangeren of vrouwen die borstvoeding geven
    7) Deelname aan een interventie studie
    8) Onmogelijkheid om instructies op te volgen
    9) Overige medische condities die het risico voor de patient vergroot of de studie resultaten kan beinvloeden, of patienten die andersinds niet geschikt zijn voor de studie
    E.5 End points
    E.5.1Primary end point(s)
    a) Dyspnea relief, assessed by VAS at baseline to day 4 (or discharge if earlier);
    b) Diuretic response (defined as Δ weight kg/[(total i.v. dose)/40mg]+[(total oral dose)/80mg)] furosemide (or equivalent loop diuretic dose) up to day 4
    c) Length of initial hospital stay;
    d) Change in NT-proBNP from baseline to day 4 (or discharge if earlier)
    - Verandering in Dyspnoe score (VAS) in de eerste 4 dagen van opname
    - Verandering in Diuretische Response in de eerste 4 dagen van opname
    - Verandering in NTproBNP levels in de eerste 4 dagen van opname
    - Verandering in opnameduur
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 days and inhospital stay (variable)
    4 dagen en tijd in ziekenhuis
    E.5.2Secondary end point(s)
    Death and/or heart failure re-admission at day 30
    Change in plasma values of renal function, including creatinine, eGFR, cystatin C, BUN, renal biomarkers and hemoglobin, hematocrit, albumin from baseline to day 4 (or discharge if earlier) or day 30
    Change in urinary renal biomarkers to day 4 o day 30
    Adverse events to 60 days
    - Dood en/of hartfalen rehospitalisatie binnen 30 dagen
    - adverse events tot 60 dagen na opname
    - Veranderingen in biomarkers van nierfunctie, hemoconcentratie en urine markers of 4 en 30 dagen
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 4 and day 30
    4 en 30 dagen
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS (telephone call)
    Laatste telefonische visite van laatste subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Treatment as usual per international guidelines
    Normale behandeling zoals omschreven in internationale richtlijnen
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation WCN Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-27
    P. End of Trial
    P.End of Trial StatusOngoing
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