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    Summary
    EudraCT Number:2020-005317-40
    Sponsor's Protocol Code Number:Herlev
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-04-07
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-005317-40
    A.3Full title of the trial
    Empagliflozin to elderly and obese patients with cardiovascular disease (Empire Prevent): A randomized controlled trial
    Empagliflozin til ældre og overvægtige patienter med hjertekarsygdom (Empire Prevent): Et randomiseret kontrolleret forsøg
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Empagliflozin to elderly and obese patients with cardiovascular disease (Empire Prevent): A randomized controlled trial
    A.4.1Sponsor's protocol code numberHerlev
    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 SponsorOdense University Hospital - Department of Cardiology
    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 supportDanish Heart Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAase og Ejnar Danielsens Fond
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAsta Florida Boldings Legat
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportArvid Nilssons Fond
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportFUHAS, Herlev Gentofte Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportOUH PhD Fund
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportSDCO PhD Fund
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportKurt & Grethe Bønnelyckes Fond
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportEva & Henry Frænkels Mindefond
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDC Academy
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportKrista og Viggo Petersens Fond
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOdense Universitetshospital
    B.5.2Functional name of contact pointJulie Hempel Larsen
    B.5.3 Address:
    B.5.3.1Street AddressJ.B. Winsløws Vej 4
    B.5.3.2Town/ cityOdense
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.4Telephone number4528935466
    B.5.6E-mailjulie.hempel.larsen@rsyd.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 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 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 placeboCoated 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
    Obese patients (BMI >28 kg/m2), aged 60-84 years, with documented cardiovascular disease but no history of diabetes mellitus or heart failure with reduced ejection fraction.
    Overvægtige patienter (BMI >28 kg/m2), i alder 60-84 år, med dokumenteret kardiovaskulær sygdom, men uden kendt sukkersyge eller hjertesvigt med nedsat pumpefunktion.
    E.1.1.1Medical condition in easily understood language
    Obese patients (BMI >28 kg/m2), aged 60-84 years, with documented cardiovascular disease but no history of diabetes mellitus or heart failure with reduced ejection fraction.
    Overvægtige patienter (BMI >28 kg/m2), i alder 60-84 år, med dokumenteret hjertekarsygdom, men uden kendt sukkersyge eller hjertesvigt med nedsat pumpefunktion.
    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
    Empire Prevent: Cardiac
    (1)To evaluate whether 6 months of treatment with 10 mg of Empagliflozin can improve peak oxygen consumption (VO2) in elderly and obese patients with cardiovascular disease.

    (2) To evaluate whether 6 months of treatment with 10 mg of Empagliflozin can reduce left ventricular (LV) mass index in elderly and obese patients with cardiovascular disease

    Empire Prevent: Metabolic
    (1)To evaluate whether 6 months of treatment with 10 mg of Empagliflozin can reduce estimated extracellular volume (eECV) in elderly and obese patients with cardiovascular disease.

    (2) To evaluate whether 6 months of treatment with 10 mg of Empagliflozin can reduce epicardial adipose tissue (EAT) in elderly and obese patients with cardiovascular disease
    E.2.2Secondary objectives of the trial
    Empire Prevent: Cardiac
    (1) To investigate whether the improvement in peak VO2 is associated with improvement in daily activity level measured by an accelerometer and self-reported quality of life.

    (2) To evaluate whether reduction in LV mass is associated with reduction in cardiac fibrosis and left atrial maximal volume.

    Empire Prevent: Metabolic
    (1) To evaluate whether the decrease in eECV is associated with a decrease in estimated plasma volume (ePV) and further, if these changes are accompanied by a reduction in s-urate and a stabilization of glomerular filtration rate.

    (2) To evaluate whether reduction in EAT is associated with a reduction in pericardial adipose tissue
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Empire Prevent Cardiac:
    (1) To evaluate whether 6 months of treatment with 10 mg of Empagliflozin reduces ambulatory blood pressure and arterial vascular stiffness (Vascular function hypothesis)

    (2) To evaluate whether 6 months treatment with 10mg of Empagliflozin reduces left atrial maximal and minimal volume (Cardiac remodeling hypothesis)

    (3) To evaluate whether 6 months of treatment with 10 mg of Empagliflozin reduces right ventricular dimensions, particularly RV end-diastolic volume index (cardiac preload hypothesis).



    Empire Prevent Metabolic:
    (1) To evaluate whether 6 months of treatment with 10 mg of Empagliflozin reduces visceral adipose tissue and improve glucose tolerance in elderly and obese patients with cardiovascular disease (Visceral adiposity and glycemic control hypothesis)

    (2) To evaluate whether 6 months of treatment with 10 mg of Empagliflozin increases erythropoietin production and induce changes in iron metabolism in elderly and obese patients with cardiovascular disease (Erythropoietic response hypothesis)

    (3) Empagliflozin improves myocardial contractile reserve by an increase in plasma concentrations of ketone bodies. (Ketone bodies hypothesis)
    E.3Principal inclusion criteria
    (1)Age 60-84 years
    (2) Bodymass index >28 kg/m2
    (3) Documented cardiovascular disease by any one of following:
    (3a) Hypertension
    (3b) Documented ischemic heart disease
    (3c) Stroke or transitory cerebral ischemia
    (3d) Chronic kidney disease with GFR 30-45 ml/min/1,72m2
    E.4Principal exclusion criteria
    (1) Diabetes mellitus (type 1 or 2)
    (2) Heart failure with ejection fraction <40%
    (3) Inability to perform exercise test
    (4) Dementia
    (5) Non-compliance
    (6) Substance abuse
    (7) GFR <30 ml/min/1,72m2
    (8) Severe chronic obstructive pulmonary disease (FEV1< 50% expected value)
    (9) Permanent atrial fibrillation
    (10) Severe peripheral artery disease
    (11) Cancer treatment within one year beside prostate cancer and basal cell carcinoma
    (12) Severe aortic or mitral valve disease
    (13) Acute hospital admission within 30 days
    (14) Participation in other pharmacological study
    (15) Pregnancy
    (16) Breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
    (1) Change from baseline in peak oxygen consumption (VO2) in elderly
    (2) Change from baseline in left ventricular (LV) mass index
    (3) Change from baseline in estimated extracellular volume (eECV)
    (4) Change from baseline in epicardial adipose tissue (EAT)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0 and day 180
    E.5.2Secondary end point(s)
    Change from baseline in:
    (1) Daily activity level measured by an accelerometer
    (2) Self-reported quality of life
    (3) Cardiac fibrosis
    (4) Left atrial maximal and minimal volume
    (5) Ambulatory blood pressure
    (6) Arterial vascular stiffness
    (7) Plasma concentrations of ketone bodies
    (8) Pericardial and paracardial adipose tissue
    (9) Visceral adipose tissue
    (10) Glycemic control
    (11) Estimated plasma volume
    (12) Secretion of erythropoietin, hepcidin and erythroferrone
    (13) Changes in ferritin, transferrin saturation and reticulocyte count
    (14) Serum urate
    (14) Glomerular filtration rate
    (15) Right ventricular dimensions (diastolic and systolic)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0 and day 180
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    End of trial when last visit of the last subject undergoind the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 104
    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 state204
    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)
    The same medical treatment as before the trial
    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 Decision2021-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-26
    P. End of Trial
    P.End of Trial StatusOngoing
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