This Study Tests Empagliflozin in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF). The Study Looks at How Far Patients Can Walk in 6 Minutes and at Their Heart Failure Symptoms

A Phase III Randomised, Double-blind Trial to Evaluate the Effect of 12 Weeks Treatment of Once Daily EMPagliflozin 10 mg Compared With Placebo on ExeRcise Ability and Heart Failure Symptoms, In Patients With Chronic HeArt FaiLure With Reduced Ejection Fraction (HFrEF) (EMPERIAL-reduced)

The primary objective of the study is to evaluate the effect of empagliflozin 10 mg versus placebo on exercise ability using the 6 minute walk test in patients with chronic HF with reduced ejection fraction (LVEF ≤ 40%) Secondary objectives are to assess Patient-Reported Outcome (PRO)

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Empagliflozin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 312
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Canberra Hospital
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital Sydney
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • University of the Sunshine Coast
    • Cairns, Queensland, Australia, 4870
      • Cairns Base Hospital
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Peninsular Health CV Research Unit
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary
  • Ontario
    • Mississauga, Ontario, Canada, L5K 2L3
      • KMH Cardiology Centres Inc.
    • Toronto, Ontario, Canada, M4P 1E4
      • Toronto Heart Centre
    • Waterloo, Ontario, Canada, N2J 1C4
      • Sameh Fikry Medicine Professional Corporation
• Germany
  • Bamberg, Germany, 96049
    • CIMS Studienzentrum Bamberg GmbH
  • Berlin, Germany, 13353
    • Charité - Universitätsmedizin Berlin
  • Berlin, Germany, 10787
    • Klinische Forschung Berlin GbR
  • Bremen, Germany, 28277
    • Bremer Institut für Herz- und Kreislaufforschung (BIHKF) am Klinikum Links der Weser
  • Dresden, Germany, 01277
    • Cardiologicum Dresden und Pirna
  • Düsseldorf, Germany, 40225
    • Universitätsklinikum Düsseldorf
  • Esslingen, Germany, 73730
    • Klinikum Esslingen GmbH
  • Frankfurt, Germany, 60596
    • IKF Pneumologie GmbH & Co. KG
  • Freiburg, Germany, 79106
    • Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH
  • Köln, Germany, 50937
    • Universitätsklinikum Köln (AöR)
  • Leipzig, Germany, 04103
    • Universitatsklinikum Leipzig
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg
• Greece
  • Athens, Greece, 14233
    • General Hospital of Athens Konstantopoulio-Agia Olga
  • Athens, Greece, 15669
    • General Hospital of Athens "G. Gennimatas"
  • Haidari, Athens, Greece, 12410
    • General University Hospital "ATTIKON"
  • Herakleion, Crete, Greece, 71110
    • University General Hospital of Heraklion
  • Ioannina, Greece, 45500
    • Univ. Gen. Hosp. of Ioannina
  • Thessaloniki, Greece, 54636
    • University Hospital of Thessaloniki AHEPA
• Italy
  • Milano, Italy, 20138
    • Centro Cardiologico Monzino-IRCCS
  • Milano, Italy, 20142
    • Asst Santi Paolo E Carlo
  • Milano, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda
  • Napoli, Italy, 80131
    • Università Federico II
  • Palermo, Italy, 90133
    • Universita degli Studi di Palermo
  • Roma, Italy, 00163
    • IRCCS San Raffaele
• Norway
  • Grålum, Norway, N-1714
    • Sykehuset Østfold Kalnes
  • Hønefoss, Norway, N-3511
    • Vestre Viken, Ringerike Sykehus HF
  • Oslo, Norway, N-0372
    • Oslo Universitetssykehus HF, Rikshospitalet
  • Stavanger, Norway, N-4011
    • Helse Stavanger, Stavanger Universitetssykehus
  • Trondheim, Norway, N-7030
    • St. Olavs Hospital, Universitetssykehuset i Trondheim
• Poland
  • Bydgoszcz, Poland, 85-605
    • INTERCORE Medical Center
  • Krakow, Poland, 30-082
    • Leszek Bryniarski Specialized Medical Cabinet
  • Lodz, Poland, 91-425
    • Card.Cli.Mil.Med.Ac.Uni.Cli.Hosp. Cent.Vetera.Hosp.Lodz
  • Lodz, Poland, 92-213
    • Cent.Clin.Hosp.Med.Univ.Lodz,Electrocard
  • Lodz, Poland, 93-513
    • Provincial Specialist M. Kopernik Hospital
  • Pulawy, Poland, 24100
    • Independent Public Healthcare, Dept. of Cardiology, Pulawy
  • Torun, Poland, 87-100
    • The Provincial Polyclinical Hospital in Torun
  • Warsaw, Poland, 02-097
    • Central Hospital of Medical Academy, Warsaw
  • Wroclaw, Poland, 50 981
    • 4. Military Clinical Hospital with Polyclinic SP ZOZ
• Portugal
  • Carnaxide, Portugal, 2795
    • CHLO, EPE - Hospital de Santa Cruz
  • Coimbra, Portugal, 3041-801
    • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
  • Leiria, Portugal, 2410-197
    • Centro Hosp. de Leiria-Pombal
  • Lisboa, Portugal, 1169-024
    • CHLC, EPE - Hospital de Santa Marta
  • Lisboa, Portugal, 1449-005
    • CHLO, EPE - Hospital S. Francisco Xavier
  • Lisboa, Portugal, 1649-035
    • CHULN, EPE - Hospital de Santa Maria
  • Penafiel, Portugal, 4560-007
    • CHTS, EPE - Hospital Padre Américo
  • Porto, Portugal, 4200-319
    • Centro Hospitalar Universitário São João,EPE
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Badalona, Spain, 08916
    • Hospital Germans Trias i Pujol
  • Granada, Spain, 18004
    • Hospital de la Inmaculada Concepción
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves
  • Granada, Spain, 18001
    • Hospital San Rafael
  • L'Hospitalet de Llobregat, Spain, 08907
    • Hospital De Bellvitge
  • Madrid, Spain, 28006
    • Hospital La Princesa
  • Valencia, Spain, 46010
    • Hospital Clinico de Valencia
• Sweden
  • Göteborg, Sweden, 413 45
    • Sahlgrenska US, Göteborg
  • Göteborg, Sweden, 416 85
    • Sahlgrenska Universitetssjukhuset, Östra
  • Stockholm, Sweden, 11446
    • Akardo Med Site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Mobile Heart Specialists, PC
    • Saraland, Alabama, United States, 36571
      • The Center for Clinical Trials, Inc.
  • California
    • Huntington Beach, California, United States, 92648
      • California Heart Specialists
    • Stockton, California, United States, 95204
      • Manshadi Heart Institute, Inc
    • Torrance, California, United States, 90502
      • University of California Los Angeles
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Western Connecticut Health Network
  • Florida
    • Miami, Florida, United States, 33133
      • Infinite Clinical Research
    • Miami, Florida, United States, 33135
      • Advance Medical Research Center
    • Miami Beach, Florida, United States, 33140
      • Bio1 Clinical Research
    • North Miami Beach, Florida, United States, 33169
      • Pharmacology Research, LLC
    • Palm Beach Gardens, Florida, United States, 33410
      • Palm Beach Gardens Research Center, LLC
    • Saint Augustine, Florida, United States, 32086
      • East Coast Institute For Research, LLC
    • Zephyrhills, Florida, United States, 33541
      • Cozy Research LLC
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital
    • Warner Robins, Georgia, United States, 31093
      • Georgia Arrhythmia Consultants and Research Institute
  • Idaho
    • Boise, Idaho, United States, 83712
      • St Luke's Clinic - Idaho Cardiology Associates
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Northwest Heart Clinical Research, LLC
    • Gurnee, Illinois, United States, 60031
      • Clinical Investigation Specialists, Inc
    • Hazel Crest, Illinois, United States, 60429
      • Chicago Medical Research
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Midwest Heart and Vascular Specialists
  • Louisiana
    • Bossier City, Louisiana, United States, 71111
      • Grace Research, LLC
    • Shreveport, Louisiana, United States, 71107
      • Grace Research, LLC
    • West Monroe, Louisiana, United States, 71291
      • Clinical Trials of America LA, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Florissant, Missouri, United States, 63031
      • Med Research One
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • The Docs
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Robert Wood Johnson Medical School
  • New York
    • Mineola, New York, United States, 11501
      • New York Heart Research Foundation, Inc.
  • North Carolina
    • Rocky Mount, North Carolina, United States, 27804
      • PMG Research of Rocky Mount, LLC
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington, LLC
  • Ohio
    • Marion, Ohio, United States, 43302
      • Rama Research LLC
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Columbia Heart Clinic
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Cardiovascular Research
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • The Jackson Clinic, PA
  • Texas
    • Beaumont, Texas, United States, 77701
      • DiscoveResearch, Inc.
    • Houston, Texas, United States, 77025
      • Angiocardiac Care of Texas
  • Virginia
    • Fredericksburg, Virginia, United States, 22401
      • Mary Washington Hospital Research Department
    • Norfolk, Virginia, United States, 23510
      • York Clinical Research, LLC
  • Wisconsin
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Of full age of consent (according to local legislation, usually ≥ 18 years) at screening.
• Male or female patients. Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
• Signed and dated written informed consent in accordance with ICHGCP and local legislation prior to admission to the trial
• 6MWT distance ≤350 m at screening and at baseline.
• Patients with chronic HF diagnosed for at least 3 months before Visit 1 and currently in NYHA class II-IV
• Chronic HF with reduced EF defined as LVEF ≤ 40 % as per echocardiography at Visit 1 as per local reading (obtained under stable condition).
• Elevated NT-proBNP > 450 pg/ml for patients without atrial fibrillation (AF) OR NTproBNP > 600 pg/ml for patients with AF as analysed at the Central laboratory at Visit 1
• Patients must be clinically stable and on appropriate and stable dose of medical therapy for HF (such as ACEi, ARB, β-blocker, oral diuretics, MRA, ARNI, ivabradine), consistent with prevailing CV guidelines, stable for at least 4 weeks prior to Visit 1(screening) with the exception of diuretics which must have been stable for at least two weeks prior to Visit 1. The investigator must document the reason in case the patient is not on such medication or if not on target dose of any heart failure medication as per local guidelines.
• Clinically stable at randomization with no signs of heart failure decompensation (as per investigator judgement).
• Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines, and if a device is required, it must have been implanted for at least 3 months prior to visit 1 for CRT and 1 month prior to visit 1 for ICD.

Exclusion Criteria:

• Myocardial infarction (increase in cardiac enzymes in combination with symptoms of ischaemia or newly developed ischaemic ECG changes), coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA in past 90 days prior to Visit 1
• Acute decompensated HF (exacerbation of chronic HF) requiring intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or left ventricular assist device within 4 weeks prior to Visit 1, and/or during screening period until Visit 2
• Previous or current randomisation in another Empagliflozin Heart Failure trial (i.e. studies 1245.110, 1245.121, 1245-0167)
• Type 1 Diabetes Mellitus (T1DM)
• Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 (CKD-EPIcr) or requiring dialysis, as determined at Visit 1
• Symptomatic hypotension or a SBP < 100 mmHg at Visit 1 or 2
• Systolic blood pressure (SBP) ≥ 180 mmHg at Visit 1 or 2, or SBP >160mmHg at both Visit 1 and 2
• Atrial fibrillation or atrial flutter with a resting heart rate >110 bpm documented by ECG at Visit 1 (Screening)
• Unstable angina pectoris in past 30 days prior to Visit 1
• Largest distance walked in 6 minutes (6MWTD) at baseline <100m.

• Any presence of condition that precludes exercise testing such as:

  • claudication,
  • uncontrolled (according to investigator judgement) bradyarrhythmia or tachyarrhythmia,
  • significant musculoskeletal disease,
  • primary pulmonary hypertension,
  • severe obesity (body mass index ≥40.0 kg/m2),
  • orthopedic conditions that limit the ability to walk (such as arthritis in the leg, knee or hip injuries)
  • amputation with artificial limb without stable prosthesis function for the past 3 months
  • Any condition that, in the opinion of the investigator, would contraindicate the assessment of 6MWT
• Patients in a structured (according to Investigator judgement) exercise training program in the 1 month prior to screening or planned to start one during the course of this trial.
• Planned implantation of ICD or CRT during the course of the trial.
• Treatment with i.v. iron therapy or erythropoietin within 3 months prior to screening
• Treatment with i.v. iron therapy or erythropoietin within 3 months prior to screening
• Further exclusion criteria applies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Film-coated tablet
EXPERIMENTAL: Empagliflozin	Drug: Empagliflozin; Film-coated tablet; Other Names: JARDIANCE, JARDIANZ, GIBTULIO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 12 in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance	Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions. If repeated 6MWT measurements were available for the same day, the longest distance was used for analysis. Change from baseline was defined as the distance walked in 6 minutes at week 12 minus the baseline value. Baseline value was defined as the last available measurement before start of treatment with randomised study medication. If a participant was present at the visit at week 12 but did not perform the 6MWT, the participant was evaluated as having walked a distance of 0 meter. If no value was available for week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above.	At baseline and at week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 12 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS)	Change from baseline in KCCQ-TSS was defined as the endpoint value at week 12 minus the last available measurement before start of treatment with randomised study medication. The KCCQ is 23 item self-administered questionnaire and comprises 7 domains: physical limitation, symptom frequency, symptom burden, symptom stability, social limitation, self-efficacy and quality of life. Additionally 3 summary scores exist: TSS, clinical summary score, and overall summary score. The scores of the KCCQ domains and summary scores range from 0 to 100, with higher score indicating better outcome. If no questionnaire was available at week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above. If no questionnaire was available at baseline, change from baseline was not imputed.	At baseline and at week 12
Change From Baseline to Week 12 in Chronic Heart Failure Questionnaire Self- Administered Standardized Format (CHQ-SAS) Dyspnea Score	Change from baseline in CHQ-SAS was defined as the endpoint value at week 12 minus the last available endpoint value before start of treatment with randomised study medication. The CHQ-SAS evaluates 3 domains: dyspnoea, fatigue, and emotional function. Scores of the domains range from 1 to 7, with higher score indicating better quality of life. If no questionnaire was available at week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above. If no questionnaire was available at baseline, change from baseline was not imputed.	At baseline and at week 12
Change From Baseline to Week 6 in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance	Change from baseline to week 6 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions. Change from baseline was defined as the distance walked in 6 minutes at week 6 minus the baseline value. Baseline value was defined as the last available measurement before start of treatment with randomised study medication. If a participant was present at the visit at week 6 but did not perform the 6MWT, the participant was evaluated as having walked a distance of 0 meter. If no value was available for week 6, an imputed value was used.	At baseline and at week 6
Change From Baseline to Week 12 in Clinical Congestion Score	Change from baseline to week 12 in Clinical Congestion score is defined as the score-value at week 12 minus the score-value at baseline. Baseline value was defined as the last available measurement before start of treatment with randomised study medication. The Clinical Congestion Score (summary score) is based on 3 items: orthopnoea, jugular venous distention (JVD) and oedema. Each item was assessed through a 4-measure questionnaire, which was further converted to a standardised 4-point scale ranging from 0 to 3, with 0 indicating no or fewer symptoms and 3 indicating continous or more symptoms. If at least 2 of the 3 items are not missing, the summary score is calculated as: (average over items JVD, orthopnea and oedema actually answered)*3. The summary score range from 0 to 9, with lower value indicating better health, and higher value indicating worse health. Mean is adjusted mean.	At baseline and at week 12
Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms	Change from baseline to week 12 in PGI-S of Heart Failure Symptoms. The Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms is a 1-item questionnaire to assess the patient's impression of symptoms severity, specifically: shortness of breath, fatigue and swelling. The PGI-S asks the Patient to choose one response that best describes how his/her heart failure symptoms, specifically: shortness of breath, fatigue and swelling are now on a 5-point scale, ranging from 'Not at all' (1) to 'Very severe' (5). Number of participants by change in score are reported. Change in score was defined as the number of categories improved/deteriorated from baseline to week 12.	At baseline and at week 12
Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) of Dyspnoea	Change from baseline to week 12 in Patient Global Impression of Severity (PGI-S) of dyspnoea. The PGI-S of Dyspnoea is a 1-item questionnaire designed to assess the participant´s impression of symptom severity, specifically dyspnoea. The PGI-S item asks the participant to choose one response that best describes how his/her dyspnoea is now on a 5-point scale, ranging from 'Not at all' (1) to 'Very severe' (5). Number of participants by change in score are reported. Change in score was defined as the number of categories improved/deteriorated from baseline to week 12.	At baseline and at week 12
Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms at Week 12	The Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms is a 1-item questionnaire to assess the patient's impression of change in heart failure symptoms, specifically: shortness of breath, fatigue, and swelling. The PGI-C asks the patient to choose one Response that best describes the overall change (if any) in his/her heart failure symptoms, specifically: shortness of breath, fatigue, and swelling since he/she started taking the study medication on a 7- category scale ranging from 'Very much better' (+3) to 'Very much worse' (-3).	At week 12
Patient Global Impression of Change (PGI-C) in Dyspnea at Week 12	The PGI-C in Dyspnoea is a 1-item questionnaire designed to assess the patient's Impression of change in dyspnoea. The PGI-C asks the patient to choose one response that best describes the change (if any) in his/her shortness of breath when performing usual activities since he/she started taking the study medication on a 7-category scale ranging from 'Very much better' (+3) to 'Very much worse' (-3).	At week 12
Relative Change From Baseline to Week 12 in N-terminal Pro-brain Natriuretic Peptide (NTproBNP)	Relative change from baseline to week 12 in N-terminal pro-brain natriuretic peptide (NTproBNP). Relative change from baseline is expressed as ratio of week 12 to baseline. Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication.	Within 3 weeks prior to treatment start and at Week 12

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Collaborators: Eli Lilly and Company

Publications and helpful links

General Publications

• Nassif ME, Kosiborod M. Effects of sodium glucose cotransporter type 2 inhibitors on heart failure. Diabetes Obes Metab. 2019 Apr;21 Suppl 2:19-23. doi: 10.1111/dom.13678.
• Anker SD, Ponikowski P, Wanner C, Pfarr E, Hauske S, Peil B, Salsali A, Ritter I, Koitka-Weber A, Brueckmann M, Lindenfeld J, Abraham WT; EMPERIAL Investigators and National Coordinators. Kidney Function After Initiation and Discontinuation of Empagliflozin in Patients With Heart Failure With and Without Type 2 Diabetes: Insights From the EMPERIAL Trials. Circulation. 2021 Oct 12;144(15):1265-1267. doi: 10.1161/CIRCULATIONAHA.121.054669. Epub 2021 Aug 16. No abstract available. Erratum In: Circulation. 2022 Feb 22;145(8):e641.
• Abraham WT, Ponikowski P, Brueckmann M, Zeller C, Macesic H, Peil B, Brun M, Ustyugova A, Jamal W, Salsali A, Lindenfeld J, Anker SD; EMPERIAL Investigators and National Coordinators. Rationale and design of the EMPERIAL-Preserved and EMPERIAL-Reduced trials of empagliflozin in patients with chronic heart failure. Eur J Heart Fail. 2019 Jul;21(7):932-942. doi: 10.1002/ejhf.1486. Epub 2019 Jun 19.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2018
• Primary Completion (ACTUAL): September 30, 2019
• Study Completion (ACTUAL): October 7, 2019

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (ACTUAL): February 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Empagliflozin
• Other Study ID Numbers: 1245-0168; 2017-004073-14 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No