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    Summary
    EudraCT Number:2017-001341-27
    Sponsor's Protocol Code Number:Empire-2017
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-04-10
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-001341-27
    A.3Full title of the trial
    Empagliflozin in heart failure patients with reduced ejection fraction:
    A randomized clinical trial (Empire HF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Empagliflozin in heart failure patients with reduced ejection fraction:
    A randomized clinical trial (Empire HF)
    A.4.1Sponsor's protocol code numberEmpire-2017
    A.5.4Other Identifiers
    Name:ClinicalTrials.gov identifierNumber:NCT03198585
    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 SponsorMorten Schou
    B.1.3.4CountryDenmark
    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 supportThe Research Council, Herlev-Gentofte University Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDepartment of Cardiology (FUKAP), Herlev-Gentofte University Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Danish Heart Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Capital Region of Denmark
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe A. P. Møller Foundation for the Advancement of Medical Science
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportSteno Diabetes Center Odense
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Cardiology, Herlev-Gentofte University Hospital
    B.5.2Functional name of contact pointJesper Jensen
    B.5.3 Address:
    B.5.3.1Street AddressHerlev Ringvej 75
    B.5.3.2Town/ cityHerlev
    B.5.3.3Post code2730
    B.5.3.4CountryDenmark
    B.5.6E-mailjesper.jensen.06@regionh.dk
    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 AuthorisationDenmark
    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.3.4Pharmaceutical form Capsule
    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 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 placeboCapsule
    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
    Heart failure with reduced ejection fraction
    E.1.1.1Medical condition in easily understood language
    Heart failure with reduced ejection fraction
    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 10078289
    E.1.2Term Heart failure with reduced ejection fraction
    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
    Main study
    To assess the effect of 3 months’ treatment with Empagliflozin 10 mg a day on changes in plasma concentrations of NT-proBNP in stable, symptomatic HF patients with reduced left ventricular ejection fraction (LVEF)
    E.2.2Secondary objectives of the trial
    Exploratory study
    To assess the effect of 3 months’ treatment with Empagliflozin 10 mg a day on daily activity level measured by patient-worn accelerometer
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-studies
    To assess the effect of 3 months’ treatment with Empagliflozin 10 mg a day on

    - Total body composition, glucose metabolism and P-ketones
    - Glomerular filtration rate (GFR), estimated extracellular volume (eECV), estimated plasma volume (ePV), uric acid and U-albumin/-creatinine ratio
    - Cardiac biomarkers
    - Left ventricular (LV) diastolic and systolic function at rest
    - Central invasive hemodynamics at rest and during exercise
    - LV global longitudinal strain (LV-GLS) and LVEF during dobutamine stress echocardiography
    - health-related quality of life
    E.3Principal inclusion criteria
    (1) Optimal Heart Failure Therapy in accordance with European and National Guidelines
    (3) LVEF ≤ 0.40
    (4) eGFR > 30 ml/min/1.73 m2
    (5) BMI < 45 kg/m2
    (6) NYHA class I-III
    (7) Age > 18 years
    (8) If T2D – optimal treatment in accordance with European and National Guidelines
    (9) If T2D – stable doses of antiglycemic treatment for 30 days
    (10) If T2D – HbA1C 6.5-10 %
    E.4Principal exclusion criteria
    (1) CRT-D/-P implanted < 90 days
    (2) Uncorrected severe valvular disease
    (3) Non-compliance
    (4) Use of metalozone
    (5) NYHA IV
    (6) Age > 85 years
    (7) Dementia
    (8) Admission for HF < 30 days
    (9) Admission for hypoglycemia < 12 month
    (10) Known sustained VT
    (11) Symptomatic hypotension and systolic BP < 95 mmHg
    (12) Unable to perform an exercise test
    (13) Immobilization
    (14) Pregnancy
    (15) Participation in other medical trials
    (16) Previous intolerance of Empagliflozin or excipients
    E.5 End points
    E.5.1Primary end point(s)
    Between-group difference in the change from baseline in plasma concentrations of NT-proBNP
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days after baseline
    E.5.2Secondary end point(s)
    Between-group difference in the change from baseline in
    (1) daily activity level measured by patient-worn accelerometers as change in the amount of daily average accelerometer units
    (2) Body composition and estimated plasma volume (ePV) assessed by DXA-scan, hematocrit (Hct) and hemoglobin (Hgb)
    (3) Glucose metabolism assessed by OGTT
    (4) Ketone supply to the heart assessed by blood ketones
    (5) Renal function and estimated extracellular volume (eECV) assessed by Cr-51 EDTA, uric acid and U-albumin/-creatinine ratio
    (6) Cardiac biomarkers assessed by MR-proADM and hs-cTNI
    (7) Cardiac systolic and diastolic function including LV-GLS and LVEF assessed by transthoracic echocardiography at rest and during stress
    (8) Cardiac hemodynamics at rest and during sub-maximal exercise assessed by right heart catheterization including PCWP/CI index and LV contractile reserve
    (9) Health-related quality of life assessed by the questionnaires KCCQ and EQ-5D-5L
    E.5.2.1Timepoint(s) of evaluation of this end point
    90 days after baseline
    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 concerned2
    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
    Last visit of the last 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 months18
    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: 57
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 133
    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 state190
    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
    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 Decision2017-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-22
    P. End of Trial
    P.End of Trial StatusCompleted
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