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    Summary
    EudraCT Number:2017-002695-45
    Sponsor's Protocol Code Number:15-156
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-12-22
    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 number2017-002695-45
    A.3Full title of the trial
    Effect of Empagliflozin on Cardiac Output in Patients with Acute Heart Failure (EMPA Acute Heart Failure)
    Der Effekt von Empagliflozin auf das Herzzeitvolumen bei Patienten mit akuter Herzinsuffizienz
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Empagliflozin on Cardiac Output in Patients with Acute Heart Failure (EMPA Acute Heart Failure)
    Wirkung von Empagliflozin auf die Herzleistung bei Patienten mit akuter Herzinsuffizienz
    A.3.2Name or abbreviated title of the trial where available
    EMPA Acute Heart Failure
    A.4.1Sponsor's protocol code number15-156
    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 SponsorRWTH Aachen University represented by the Rector, himself, represented by the Dean of the Medical Faculty
    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
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCenter for Transitional & Clinical Research Aachen (CTC-A)
    B.5.2Functional name of contact pointClinical Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressPauwelsstraße 30
    B.5.3.2Town/ cityAachen
    B.5.3.3Post code52074
    B.5.3.4CountryGermany
    B.5.4Telephone number+492418080092
    B.5.5Fax number+49241803380092
    B.5.6E-mailmkortmann@ukaachen.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.3.2Product code BI 10773
    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.3.9.4EV Substance CodeSUB35915
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Patients with acute heart failure
    Patienten mit akuter Herzinsuffizienz
    E.1.1.1Medical condition in easily understood language
    Patients diagnosed with acute heart failure and with or without diabetes typ 2 to assess the impact of Empagliflozin on hemodynamic and cardiac function
    Patienten mit akuter Herzinsuffizienz und mit oder ohne Diabetes mellitus Typ 2 zur Beurteilung der Wirkung von Empagliflozin auf Hämodynamik und Herzfunktion.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To examine the effect of Empagliflozin 10mg qd versus placebo on cardiac output in patients with acute heart failure.
    E.2.2Secondary objectives of the trial
    Effect of Empagliflozin on systemic vascular resistance, stroke volume, left ventricular systolic and diastolic function, exercise capacity, patient-reported dyspnea, peak expiratory flow rate, clinical judged diuretic requirement, heart rate variability, percentage of supraventricular and ventricular contraction of total heart beats, NT-proBNP, eGFR, cystatin c, kidney injury risk score (defined by TIMP-2 x IGFBP7), sodium excretion and metabolic parameters (glucagon, insulin, total-ketone bodies, -hydroxybutyrate, etc.) in patients with acute heart failure
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Patients with acute heart failure with associated signs or
    symptoms (dyspnea on exertion, orthopnea, paroxysmal
    dyspnea, peripheral oedema, chest x-ray with pulmonary
    congestion)
    3. Serum levels of NT-proBNP ≥ 1000 pg/ml within 48 hours of informed consent
    4. Written informed consent prior to study participation
    E.4Principal exclusion criteria
    1. Type 1 diabetes
    2. Participants of child-bearing age without adequate contraception
    3. Pregnancy or lactating females
    4. Cardiogenic shock
    5. Acute coronary syndrome within 30 days prior to randomization
    6. Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization
    7. Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH ≤ 7.30 and glucose >14 mmol/l and HCO3- ≤ 18 mmol/l)
    8. uncontrolled active infection
    9. Primary cause of dyspnea due to non-cardiac, non-HF causes such as acute or chronic respiratory disorders
    10. Coronary artery disease with planned revascularization within the study period
    11. Renal impairment (GFR < 20 ml/min/1,73 m2)
    12. Known hepatic impairment (as evidenced by total bilirubin >3 mg/dL) or history of cirrhosis with evidence of portal hypertension (e.g., presence of esophageal varices)
    13. Uncontrolled thyroid disease
    14. Uncontrolled Endocrinopathies like Graves’ disease, acromegaly,
    Cushings’ disease
    15. Hypertensive retinopathy or encephalopathy
    16. Bariatric surgery in last 2 years prior to randomization
    17. Patients in whom study participation is not deemed appropriate under consideration of clinical wellbeing by the principal investigator
    18. The subject is mentally or legally incapacitated
    19. The subject received an investigational drug within 30 days
    prior to inclusion into this study
    20. Urinary tract infections or significant formation of residual urine in medical history
    21. Patients with particular risk for ketoacidosis (alcohol abuse, pancreatitis, pancreatic insulin deficiency from any cause, caloric restriction etc.) or ketoacidosis in the past
    22. Frequent hypoglycaemic events (in the opinion of the investigator)
    23. Intolerance to Empagliflozin and excipients in Empagliflozin or rather placebo
    24. Patients with severe stenosis or regurgitation of the aortic, pulmonary or mitral valve
    E.5 End points
    E.5.1Primary end point(s)
    Effect of Empagliflozin 10 mg once daily on cardiac output by ClearSight System in comparison to placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and 6 hours, day 1, 3, 7 and 30 following treatment initiation
    E.5.2Secondary end point(s)
    Most important secondary endpoints:
    Effect of Empagliflozin 10 mg once daily on
    - Systemic vascular resistance (ClearSight System)
    - Stroke volume (ClearSight System)
    - Exercise capacity (Hand grip)
    - Patient-reported dyspnea (visual analogue scale (VAS), 7 point categorical Likert scale)
    - Peak expiratory flow rate
    - Oxygen saturation (%)
    - Respiratory rate (breaths/min)
    - Oxygen delivered (l/min)
    - Clinical judged diuretic requirement
    - Diuretic response (defined as Δ weight kg/[(total i.v. dose)/40mg]+[(total oral dose)/80mg)] furosemide (or equivalent loop diuretic dose)
    - Serum NT-proBNP
    - Kidney injury risk score by NephroCheck® (defined by TIMP-2 x IGFBP7 in urine)
    - eGFR
    - Serum Cystatin C
    - Lactate, pH, HCO3-
    - Blood pressure
    - Heart rate
    - Heart rate variability (24 h ECG)
    - Percent of supraventricular and ventricular contraction of total heart beats (24 h ECG)
    - Body weight
    - Urinary volume
    - Sodium excretion in 24 h urine collection (osmolarity, sodium, creatine, chloride, potassium, creatine-clearance, protein, urea nitrogen, magnesium, phosphate, glucose, calcium, uric acid)
    - Serum osmolarity, potassium, chloride
    - Serum levels of glucose, glucagon, insulin, total-ketone bodies, β-hydroxybutyrate, aldosterone, free fatty acids
    - Hemoglobin, haematocrit, erythropoietin levels

    in comparison to placebo at baseline and 6 hours, day 1, 3, 7 and 30 following treatment initiation.
    Effect of Empagliflozin 10 mg once daily on
    - Microbiome analysis

    in comparison to placebo at baseline after 7 and 30 days of treatment
    Effect of Empagliflozin 10 mg once daily on
    - Left ventricular systolic function (ejection fraction)
    - Left ventricular diastolic function (2D and 3D parameter global strain rate E by echocardiography and by standardized parameter E/E’ and left atrial (LA) volume)

    in comparison to placebo at baseline after 30 days of treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at baseline and after 6 hours, day 1, 3, 7 and 30 following treatment initiation
    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 No
    E.6.5Efficacy No
    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 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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    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: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state50
    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)
    Patients are treated according to the study protocol and in accordance with the normal standards of medical care.
    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 Decision2018-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-10-29
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