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    Summary
    EudraCT Number:2018-003692-35
    Sponsor's Protocol Code Number:ZKSJ0109
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-02-14
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2018-003692-35
    A.3Full title of the trial
    Effects of empagliflozin on diuresis and renal function in patients with acute decompensated heart failure
    Auswirkungen von Empagliflozin auf Diurese und Nierenfunktion bei Patienten mit akuter dekompensierter Herzinsuffizienz
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of empagliflozin on urine output and renal function in patients with acute heart failure
    Auswirkungen von Emagliflozin auf die Urinproduktion und Nierenfunktion auf Patienten mit akuter Herzschwäche
    A.3.2Name or abbreviated title of the trial where available
    EMPAG-HF
    EMPAG-HF
    A.4.1Sponsor's protocol code numberZKSJ0109
    A.5.4Other Identifiers
    Name:ZKS Protocol CodeNumber:ZKSJ0109_EMPAG-HF
    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 SponsorFriedrich Schiller University Jena
    B.1.3.4CountryGermany
    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 Pharma GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Jena, Zentrum für Klinische Studien
    B.5.2Functional name of contact pointCenter for Clinical Studies
    B.5.3 Address:
    B.5.3.1Street AddressS. Allende-Platz 27
    B.5.3.2Town/ cityJena
    B.5.3.3Post code07747
    B.5.3.4CountryGermany
    B.5.4Telephone number004936419396625
    B.5.5Fax number004936419399969
    B.5.6E-mailsabine.barta@med.uni-jena.de
    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 Jardiance
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEmpagliflozin
    D.3.9.1CAS number 864070-44-0
    D.3.9.3Other descriptive nameEMPAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB35915
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboFilm-coated tablet
    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
    akute dekompensierte Herzinsuffizienz
    E.1.1.1Medical condition in easily understood language
    acute heart failure
    akute Herzschwäche
    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 LLT
    E.1.2Classification code 10000803
    E.1.2Term Acute heart failure
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of empagliflozin plus loop diuretics versus placebo plus loop diuretics in patients with ADHF on the increase of urine output
    Die Beurteilung der Wirksamkeit von Empagliflozin plus Schleifendiuretika im Vergleich zu Placebo plus Schleifendiuretika bei Patienten mit ADHF auf die Urinproduktion
    E.2.2Secondary objectives of the trial
    To evaluate the effects of empagliflozin plus loop diuretics versus placebo plus loop diuretics in patients with ADHF, in terms of renal function, length of hospital stay, quality of life, insulin resistance and the need for further administration of diuretics
    Die Beurteilung der Wirkung von Empagliflozin plus Schleifendiuretika im Vergleich zu Placebo plus Schleifendiuretika bei Patienten mit ADHF hinsichtlich der Nierenfunktion, der Dauer des Krankenhausaufenthalts, der Lebensqualität, der Insulinresistenz und der Notwendigkeit derr weiteren Verabreichung von Diuretika
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients (between 18 - 85 years) with acute decompensated heart failure (HF).
    • Brain Natriuretic Peptide (BNP) >100 pg/ml, or N-terminal pro-BNP (NT-proBNP)>300 pg/ml as defined by current clinical guidelines for the diagnosis of acute decompensated HF (European Society of Cardiology 2016 HF guideline)
    • Patients with diabetes mellitus type 2 or impaired glucose tolerance as defined by current clinical guidelines (German and International Diabetes Society 2016: HbA1c>6.5 % (upper limit for this clinical Trial 12%) or fasting glucose >7.0 mmol/l or any incidental glucose level >11.1 mmol/l or abnormal oral glucose tolerance test with 2h plasma glucose >7.8 mmol/l) or on antidiabetic medication or antidiabetic diet or patients with normal glucose tolerance
    • Patients without cognitive impairment, i.e. they must be capable of understanding the nature, significance and implications of the clinical trial and to form a rational intention in the light of the Facts
    • Written informed consent obtained
    • For women with childbearing potential (until 2 years after menopause):
    o Negative pregnancy test
    o regular and correct use of a highly effective contraceptive method with an error rate of <1% per year (e.g. combined (estrogen and progesteron) hormonal contraception, (oral, intravaginal, transdermal), progesteron-only hormonal contraception, (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system ( IUS)) tubal ligation (female sterilization), hormon donating intrauterine device ("hormonal spiral"), double barrier methods, sexual abstinence, vasectomy of the partner)

    • Patienten (Alter zwischen 18-85 Jahre) mit akuter dekompensierter Herzinsuffizienz (HF).
    • Brain Natriuretic Peptide (BNP) >100 pg/ml oder N-terminales Pro-BNP (NT-proBNP)> 300 pg / ml gemäß den aktuellen klinischen Leitlinien für die Diagnose von akut dekompensiertem HF (European Society of Cardiology 2016 HF Richtlinie)
    • Patienten mit Diabetes mellitus Typ 2 oder gestörter Glukosetoleranz gemäß den aktuellen klinischen Leitlinien (Deutsche und Internationale Diabetes-Gesellschaft 2016: HbA1c> 6,5% (oberes Limit bei dieser Studie ist 12%) oder Nüchternglucose> 7,0 mmol / l oder beliebiger Glukosespiegel> 11,1 mmol / l oder abnormaler oraler Glukosetoleranztest mit 2h Plasmaglukose> 7,8 mmol / l) oder auf Antidiabetika oder Antidiabetik Diät oder Patienten mit normaler Glukosetoleranz
    • Patienten ohne kognitive Beeinträchtigung, d.h. sie müssen in der Lage sein, die Art, die Bedeutung und die Auswirkungen der klinischen Studie zu verstehen und sich im Anbetracht der Fakten eine vernünftige Meinung zu bilden
    • schriftliche Einwilligungserklärung erhalten
    • Für potentiell gebärfähige Frauen (bis 2 Jahre nach der Menopause):
    o negativer Schwangerschaftstest)
    o regelmäßige und korrekte Anwendung einer hochwirksamen Verhütungsmethode mit einer Fehlerrate von <1% pro Jahr (z. B. kombinierte hormonelle Kontrazeption (Östrogen und Progesteron) (oral, intravaginal, transdermal), hormonelle Kontrazeption nur Progesteron (oral, injizierbar, implantierbar), intrauterines Gerät (IUD), intrauterines Hormon-Releasing-System (IUS)) Tubenligatur (Sterilisation von Frauen), hormonspendendes Intrauterinprodukt ("Hormonspirale"), Doppelbarrierenmethoden, sexuelle Abstinenz, Vasektomie des Partners)

    E.4Principal exclusion criteria
    • Type 1 diabetes mellitus
    • Chronic Kidney Disease (CKD) with eGFR< 30 ml/min (if obviously not related to acute kidney injury), or end-stage renal failure with the need for chronic dialysis treatment
    • Acute kidney injury (AKI) ≥AKIN stage 2 or requiring dialysis treatment
    • Current medication with SGLT-2 inhibitors
    • Known intolerance or hypersensitivity to the active substance empagliflozin, lactose or any other of the excipients listed in section 6.1. of the SmPC
    • A contraindication or intolerance to furosemide
    • Acute heart failure without signs of congestion (“dry” patient)
    •Indication for urgent coronary angiography or planned administration of a iodine based contrast agent within the next 6 days.
    • Need for hemofiltration or any other form of extracorporeal therapy
    • Planned surgery
    • Recent participation in another clinical trial (within the last 3 months before inclusion, so that medical product/s from previous trial participation/s have been fully washed out )
    • Identification of any causes of heart failure leading to decompensation that needs urgent management (like acute coronary syndrome, severe unstable arrhythmias, mechanical causes, acute pulmonary embolism)
    • Incapacity to understand and / or to provide written informed consent
    • Ongoing reported alcohol abuse (daily alcohol intake of more than 2 drinks (liquor, beer or wine) in men and 1 drink in women, corresponding to 12/24 g of pure alcohol per day women / men and/ or obvious alcoholisation of the patient during screening )
    • Diabetes mellitus Typ 1
    • Chronische Nierenerkrankung (CKD) mit eGFR <30 ml / min (falls offensichtlich kein Zusammenhang mit akuter Nierenschädigung besteht) oder Nierenversagen im Endstadium mit der Notwendigkeit einer chronischen Dialysebehandlung
    • Akute Nierenverletzung (AKI) ≥AKIN Stufe 2 oder Dialysebehandlung erforderlich
    • Aktuelle Medikamente mit SGLT-2-Inhibitoren
    • Bekannte Intoleranz oder Überempfindlichkeit gegen den Wirkstoff Empagliflozin, Laktose oder einen der in Abschnitt 6.1 genannten sonstigen Bestandteile. der SmPC (Fachinformation)
    • Eine Kontraindikation oder Intoleranz gegenüber Furosemid
    • Akute Herzinsuffizienz ohne Anzeichen von Stauungen ("trockener" Patient)
    •Indikation für eine dringende Koronarangiographie oder geplante Gabe eines Iod-haltigen Kontrastmittels innerhalb der nächsten 6 Tage
    • Notwendigkeit einer Hämofiltration oder einer anderen Form der extrakorporalen Therapie
    • Geplanter operativer Eingriff
    • Vorhergehende Teilnahme an dieser Studie oder kürzlich erfolgte Teilnahme einer anderen klinischen Studie (innerhalb der letzten 3 Monate vor Einschluss, so dass die medizinischen Produkte aus vorherige/n Teilnahme/n vollständig ausgewaschen wurden)
    • Ermittlung aller Ursachen von Herzversagen, die zu einer Dekompensation führen, die ein dringendes Management erfordert (wie akutes Koronarsyndrom, schwere instabile Arrhythmien, mechanische Ursachen, akute Lungenembolie)
    • Unfähigkeit, schriftliche Einverständniserklärung zu verstehen und / oder zu erteilen
    • Anhaltender berichteter Alkoholmissbrauch (tägliche Alkoholaufnahme von mehr als 2 Getränken (Schnaps, Bier oder Wein) bei Männern und 1 Getränk bei Frauen, entsprechend 12/24 g reinem Alkohol pro Tag Frauen / Männer und / oder einer offensichtlichen Alkoholisierung des Patienten während des Screenings)
    E.5 End points
    E.5.1Primary end point(s)
    Total urine output as measured by daily volume summed up over 5 days
    Auswertung der gesamten Harnausscheidung, gemessen am Tagesvolumen, summiert über 5 Tage
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 5 days of therapy with Empaglifozin
    nach 5 Tagen Empagliflozin Therapie
    E.5.2Secondary end point(s)
    • Daily urine volume measured over 5 days
    • Renal function under treatment
    • Increase in serum creatinine of >0.3 mg/dl
    • Doubling of serum creatinine
    • Need for renal replacement therapy
    • Net fluid output
    • Total urinary sodium excretion
    • Fractional excretion of sodium
    • Change of insulin resistance (Homa-IR)
    • Cumulative dosage of diuretics and diuretics efficiency by net urinary output (UOP) in ml/mg furosemide and total daily UOP in ml/mg furosemide
    • Change in body weight from baseline to 72 hours
    • Duration of IV furosemide
    • Additional ADHF therapy
    • Severity of HF (Symptombasierter Kurzfragebogen )
    • Severity of dyspnea (NYHA class)
    • Peripheral oedema (per clinical judgement)
    • Elevated jugular venous pulse pressure
    • Quality of life (EQ-5D-3L)
    • Change in NT-proBNP at 72 hr
    • Worsening or persistent heart failure
    • IMC / ICU and hospital length of stay
    • Liver function (bilirubin, serum aminotransferases, relevant change in coagulation status)
    • Pulmonary function: oxygen saturation without oxygen therapy/ need for oxygen in l/min, presence of rales, changes in chest x-ray (worsening/ improvement/ new infiltration)
    • Number of patients alive and out of hospital -after 30 days
    • Tägliches Urinvolumen, gemessen über 5 Tage
    • Nierenfunktion unter Behandlung
    • Erhöhung des Serumkreatinins von> 0,3 mg / dl
    • Verdoppelung des Serumkreatinins
    • Notwendigkeit einer Nierenersatztherapie
    • Netto-Flüssigkeitsabgabe
    • Gesamte Natriumausscheidung im Urin
    • Fraktionierte Ausscheidung von Natrium
    • Veränderung der Insulinresistenz (Homa-IR)
    • Kumulative Dosierung der Wirksamkeit von Diuretika und Diuretika durch Netto-Urinausscheidung (UOP) in ml / mg Furosemid und tägliche Gesamt-UOP in ml / mg Furosemid
    • Veränderung des Körpergewichts von Baseline bis 72 Stunden
    • Dauer von IV Furosemid-Gabe
    • Zusätzliche ADHF-Therapie
    • Schwere der HF (Symptombasierter Kurzfragebogen)
    • Schweregrad der Dyspnoe (NYHA-Klasse)
    • Periphere Ödeme (nach klinischem Ermessen)
    • Erhöhter jugularvenöser Pulsdruck
    • Lebensqualität (EQ-5D-3L)
    • Änderung des NT-proBNP Zeitpunkt nach 72 Stunden
    • Verschlechterung oder anhaltende Herzinsuffizienz
    • IMC / ICU und Krankenhausaufenthaltsdauer
    • Leberfunktion (Bilirubin, Serum-Aminotransferasen, relevante Veränderung des Gerinnungsstatus)
    • Lungenfunktion: Sauerstoffsättigung ohne Sauerstofftherapie / Sauerstoffbedarf in l / min, Vorhandensein von Rasselgeräuschen, Veränderungen der Thoraxröntgenaufnahme (Verschlimmerung / Besserung / Neuinfiltration)
    • Anzahl der Patienten, nach 30 Tagen lebend und aus dem Krankenhaus entlassen
    E.5.2.1Timepoint(s) of evaluation of this end point
    different timepoints until day 5 after randomisation, hospital discharge and at follow-up visit day 30 after randomisation
    unterschiedliche Zeitpunkte, bis Tag 5 nach Randomisierung, Tag der Krankenhausentlassung und Follow-Up Visite an Tag 30 ab Tag der Randomisierung
    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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Time point of data hard lock after SAE follow-ups and resolution of all existing queries
    Zeitpunkt des Datenlocks nach SAE-Nachverfolgung und Auflösung aller vorhandenen Queries
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-02-14. Yes
    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 state60
    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)
    None
    Keine
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-29
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