AzTrials
AzTrials

Heart FailurePhase 3NCT03057977

EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)

A Phase 3 study testing Empagliflozin in people with Heart Failure, run by Boehringer Ingelheim at 520 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Empagliflozin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,730 participants
Where
520 sitesin 20 countries
Study dates
6 Mar 2017to 28 May 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
  • Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
  • If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
  • If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
  • If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
  • EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
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  • Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
  • Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
  • Signed and dated written ICF (Informed Consent Form)
  • Further inclusion criteria apply

Who cannot join

  • Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
  • Heart transplant recipient, or listed for heart transplant
  • Acute decompensated HF
  • Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
  • Symptomatic hypotension and/or a SBP < 100 mmHg
  • Indication of liver disease
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  • Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
  • History of ketoacidosis
  • Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
  • Currently enrolled in another investigational device or drug study
  • Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial
  • Further exclusion criteria apply

Trial locations and contacts

520 sites in 20 countries.

520 sites in 20 countries

United States92 sites

  • Cambridge Medical Trials

    Alexandria, Louisiana, 71301

  • Alpena General Hospital

    Alpena, Michigan, 49707

  • AnMed Health Clinical Research

    Anderson, South Carolina, 29621

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Northwest Heart Clinical Research, LLC

    Arlington Heights, Illinois, 60005

  • Asheville Cardiology Associates

    Asheville, North Carolina, 28803

  • Grady Clinical Research Center

    Atlanta, Georgia, 30303

  • Augusta University

    Augusta, Georgia, 30912

  • Johns Hopkins University Hospital School of Medicine

    Baltimore, Maryland, 21205

  • MedStar Health Research Institute

    Baltimore, Maryland, 21237

  • Metropolitan Cardiovascular Consultants

    Beltsville, Maryland, 20705

  • Integrated Heart Care

    Boca Raton, Florida, 33434

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Advanced Heart Care, LLC

    Bridgewater, New Jersey, 08807

  • Kernodle Clinic West

    Burlington, North Carolina, 27215

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-5021

  • Ralph H. Johnson VA Medical Center

    Charleston, South Carolina, 29401

  • Novant Health Heart and Vascular Institute

    Charlotte, North Carolina, 28204

  • Trinity Medical WNY, PC

    Cheektowaga, New York, 14227

  • Cardiac Health Management Network, P.C.

    Chester, Virginia, 23836

  • University of Chicago

    Chicago, Illinois, 60637

  • Morton Plant Mease Health Care

    Clearwater, Florida, 33756

  • Palmetto Health

    Columbia, South Carolina, 29203

  • William Jennings Bryan Dorn VA Medical Center

    Columbia, South Carolina, 29209

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Louisiana Heart Center

    Covington, Louisiana, 70433

  • Nature Coast Clinical Research

    Crystal River, Florida, 34429

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226

  • Soltero Cardiovascular Research Center

    Dallas, Texas, 75226

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-8837

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Doylestown Health Cardiology

    Doylestown, Pennsylvania, 18901

  • Duke University Medical Center

    Durham, North Carolina, 27609

  • Midwest Cardiovascular Research and Education Foundation

    Elkhart, Indiana, 46514

  • Alpine Research Organization

    Farmington, Utah, 84025

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Integrative Research Associates

    Fort Lauderdale, Florida, 33312

  • University of North Texas Health Science Center

    Fort Worth, Texas, 76107

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054

  • East Mountain Medical Associates, PC

    Great Barrington, Massachusetts, 01230

  • Northwell Health

    Great Neck, New York, 11021

  • The Methodist Hospital

    Houston, Texas, 77030

  • St. Francis Medical Group-Indiana Heart Physicians, Inc

    Indianapolis, Indiana, 46237

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32216

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • La Mesa Cardiac Center

    La Mesa, California, 91942

  • Mount Sinai School of Medicine

    Lake Success, New York, 11041

  • Palm Research Center

    Las Vegas, Nevada, 89148

  • Cardiovascular Group PC

    Lawrenceville, Georgia, 30046

  • Clinical Trials of America, Inc

    Lenoir, North Carolina, 28645

  • South Denver Cardiology Associates, PC

    Littleton, Colorado, 80120

  • Long Beach Center for Clinical Research

    Long Beach, California, 90807

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • Rama Research LLC

    Marion, Ohio, 43302

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Methodist University Hospital

    Memphis, Tennessee, 38104

  • Merced Vein and Vascular Center

    Merced, California, 95340

  • Cardiovascular Research Center of South Florida

    Miami, Florida, 33173

  • Clinical Trials of America, LLC

    Monroe, Louisiana, 71201

  • Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

  • St. Luke's Roosevelt Hospital

    New York, New York, 10025

  • Harlem Cardiology

    New York, New York, 10035

  • Captain James A. Lovell Federal Health Care Center

    North Chicago, Illinois, 60064

  • South Oklahoma Heart Research Group

    Oklahoma City, Oklahoma, 73135

  • University of California Irvine

    Orange, California, 92865

  • Peninsula Research, Inc.

    Ormond Beach, Florida, 32174

  • Research Integrity, LLC

    Owensboro, Kentucky, 42303

  • Cardiology Consultants, Inc

    Pensacola, Florida, 32501

  • The Heart Hospital

    Plano, Texas, 75093

  • Reid Hospital

    Richmond, Indiana, 47374

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia, 23249

  • Covigilant Research, LLC

    Riverside, California, 92506

  • Roanoke Heart Institute PLC

    Roanoke, Virginia, 24014

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732

  • Rockford Cardiovascular Associates

    Rockford, Illinois, 61107

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Salem VA Medical Center

    Salem, Virginia, 24153

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Meridian Clinical Research, LLC

    Savannah, Georgia, 31406

  • Beacon Medical Group Clinical Research

    South Bend, Indiana, 46601

  • Palmetto Research Center, LLC

    Spartanburg, South Carolina, 29302

  • Saint Louis University

    St Louis, Missouri, 63110

  • SLHV

    St Louis, Missouri, 63136

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Cardiac Care and Vascular Medicine, PLLC

    The Bronx, New York, 10469

  • University of Toledo

    Toledo, Ohio, 43614

  • University of California

    Torrance, California, 90502

  • Spectrum Clinical Research

    Towson, Maryland, 21204

  • Orange County Research Center

    Tustin, California, 92780

  • Blue Coast Cardiology

    Vista, California, 92083

  • York Hospital, WellSpan Health

    York, Pennsylvania, 17403

Other trials in United States

Japan66 sites

  • Kasugai Municipal Hospital

    Aichi, Kasugai, 486-8510

  • Nagoya Kyoritsu Hospital

    Aichi, Nagoya, 454-0933

  • Japanese Red Cross Nagoya Daini Hospital

    Aichi, Nagoya, 466-8650

  • Toyota Memorial Hospital

    Aichi, Toyota, 471-8513

  • Chiba Heart Clinic

    Chiba, Chiba, 263-0043

  • Kimitsu Chuo Hospital

    Chiba, Kisarazu, 292-8535

  • Seikeikai New Tokyo Heart Clinic

    Chiba, Matsudo, 271-0077

  • Ehime Prefectural Central Hospital

    Ehime, Matsuyama, 790-0024

  • Matsuyama Shimin Hospital

    Ehime, Matsuyama, 790-0067

  • Uwajima City Hospital

    Ehime, Uwajima, 798-8510

  • Fukuiken Saiseikai Hospital

    Fukui, Fukui, 918-8503

  • Fukuoka University Chikushi Hospital

    Fukuoka, Chikushino, 818-8502

  • Fukuokaken Saiseikai Futsukaichi Hospital

    Fukuoka, Chikushino, 818-8516

  • Saiseikai Fukuoka General Hospital

    Fukuoka, Fukuoka, 810-0001

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Aso Co.,Ltd Iizuka Hospital

    Fukuoka, Iizuka, 820-8505

  • Steel Memorial Yawata Hospital

    Fukuoka, Kitakyushu, 805-8508

  • Japan Community Health Care Organization Kyushu Hospital

    Fukuoka, Kitakyushu, 806-8501

  • Ogaki Municipal Hospital

    Gifu, Ogaki, 503-8502

  • Chuno Kosei Hospital

    Gifu, Seki, 501-3802

  • Fukuyama City Hospital

    Hiroshima, Fukuyama, 721-8511

  • JA Hiroshima General Hospital

    Hiroshima, Hatsukaichi, 738-8503

  • Shobara Red Cross Hospital

    Hiroshima, Shobara, 727-0013

  • National Hospital Organization Hakodate Hospital

    Hokkaido, Hakodate, 041-8512

  • Teine Keijinkai Clinic

    Hokkaido, Sapporo, 006-0811

  • Tomakomai City Hospital

    Hokkaido, Tomakomai, 053-8567

  • Hyogo Prefectural Amagasaki General Medical Center

    Hyogo, Amagasaki, 660-8550

  • Hyogo Brain and Heart Center

    Hyogo, Himeji, 670-0981

  • National Hospital Organization Kobe Medical Center

    Hyogo, Kobe, 654-0155

  • Mito Medical Center

    Ibaraki, Higashiibaraki-gun, 311-3193

  • National Hospital Organization Kanazawa Medical Center

    Ishikawa, Kanazawa, 920-8650

  • Mitoyo General Hospital

    Kagawa, Kanonji, 769-1695

  • Kagawa Prefectural Central Hospital

    Kagawa, Takamatsu, 760-8557

  • Yamamoto Clinic

    Kanagawa, Sagamihara, 252-0311

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, Yokohama, 236-0051

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, Kumamoto, 861-8520

  • Seiwakai Suizenji Touya Hospital

    Kumamoto, Kumamoto, 862-0950

  • Kumamoto Rosai Hospital

    Kumamoto, Yatsushiro, 866-8533

  • Uji-Tokushukai Medical Center

    Kyoto, Uji, 611-0041

  • Sendai Kousei Hospital

    Miyagi, Sendai, 980-0873

  • Sendai Tokushukai Hospital

    Miyagi, Sendai, 981-3131

  • The Cardiovascular Center of Sendai

    Miyagi, Sendai, 981-3133

  • National Hospital Organization Sendai Medical Center

    Miyagi, Sendai, 983-8520

  • Miyazaki Medical Association Hospital

    Miyazaki, Miyazaki, 880-0834

  • Hokushin General Hospital

    Nagano, Nakano, 383-8505

  • Nagasaki Medical Center

    Nagasaki, Omura, 856-8562

  • Okayama City General Medical Center

    Okayama, Okayama, 700-8557

  • Naha City Hospital

    Okinawa, Naha, 902-8511

  • Nanbu Tokushukai Hospital

    Okinawa, Shimajiri-gun, 901-0493

  • Urasoe General Hospital

    Okinawa, Urasoe, 901-2132

  • Higashiosaka City Medical Center

    Osaka, Higashiosaka, 578-8588

  • Kitano Hospital

    Osaka, Osaka, 530-8480

  • Yodogawa Christian Hospital

    Osaka, Osaka, 533-0024

  • Seichokai Bell Land General Hospital

    Osaka, Sakai, 599-8247

  • Hokusetsu General Hospital

    Osaka, Takatsuki, 569-8585

  • San-Ai Hospital

    Saitama, Saitama, 338-0837

  • Kosekai Iwatsuki-minami Hospital

    Saitama, Saitama, 339-0033

  • Kusatsu General Hospital

    Shiga, Kusatsu, 525-8585

  • Tokushima Prefectural Central Hospital

    Tokushima, Tokushima, 770-8539

  • National Hospital Organization Tokyo Medical Center

    Tokyo, Meguro-ku, 152-8902

  • Ome Municipal General Hospital

    Tokyo, Ome, 198-0042

  • Tokyo Rosai Hospital

    Tokyo, Ota-ku, 143-0013

  • Sekino Hospital

    Tokyo, Toshima-ku, 171-0014

  • Minami Wakayama Medical Center

    Wakayama, Tanabe, 646-8558

  • Kanmon Medical Center

    Yamaguchi, Shimonoseki, 752-8510

Other trials in Japan

Argentina40 sites

  • Hospital Interzonal General de Agudos Dr Jose Penna

    Bahía Blanca, B8001DDU

  • Hospital Italiano Regional del Sur, Bahia Blanca

    Bahía Blanca, B8001HXM

  • CIPREC

    CABA, C1119ACN

  • Hospital Italiano de Buenos Aires

    CABA, C1199ABB

  • Consultorios Asociados de Endocrinología e Invest Clínica

    Ciudad Autonoma Buenos Aires, C1425AGC

  • Instituto Cardiovascular de Buenos Aires

    Ciudad Autonoma Buenos Aires, C1428ART

  • CCBR - Buenos Aires - AR

    Ciudad Autonoma Buenos Aires, C1430CKE

  • Centro Médico Viamonte

    Ciudad Autonoma de Bs As, C1120AAC

  • Sanatorio Güemes

    Ciudad Autónoma de Bs As, C1180AAX

  • Instituto Medico Elsa Perez SRL (IMEP)

    Ciudadela, 1702

  • Sanatorio Mayo Privado SA

    Córdoba, 5000

  • Centro de Investigaciones Clinicas Instituto del Corazon

    Córdoba, X5000EVQ

  • Sanatorio Allende S.A.

    Córdoba, X5000JHQ

  • Clínica Colombo

    Córdoba, X5002AOQ

  • Instituto Médico DAMIC S.R.L.

    Córdoba, X5003DCE

  • Hospital Privado

    Córdoba, X5016KEH

  • Clinica Coronel Suarez SA

    Coronel Suárez, B7540DOL

  • Instituto de Cardiología de Corrientes

    Corrientes, W3400AMZ

  • Hospital Italiano de La Plata

    La Plata, B1900AXI

  • Centro de Investigaciones Médicas

    Mar del Plata, B7600FYK

  • Hospital Privado de Comunidad

    Mar del Plata, B7602CBM

  • Clínica Olivos

    Olivos, 1602

  • CER Instituto Médico

    Quilmes, B1878DVB

  • Instituto de Investigaciones Clínicas de Quilmes

    Quilmes, B1878GEG

  • Instituto de Investigaciones Clinicas de Rosario

    Rosario, 2000

  • Instituto Medico Fundación Grupo Colaborativo Rosario

    Rosario, 2000

  • Sanatorio Británico

    Rosario, 2000

  • Sanatorio Plaza

    Rosario, 2000

  • Sanatorio Parque

    Rosario, S2000DSV

  • Instituto CAICI

    Rosario, S2000PBJ

  • CORDIS S.A., Salta

    Salta, A4400ANW

  • Centro Cardiovascular Salta

    Salta, A4406BFP

  • Corporacion Medica de Gral. San Martin S.A.

    San Martin, B1650CSQ

  • Investigaciones Clinicas Tucuman

    San Miguel de Tucumán, T4000ICL

  • Instituto de Cardiología

    San Miguel de Tucumán, T4000JCU

  • CCBR Tucuman

    San Miguel de Tucumán, T4000

  • Centro Medico Luquez

    San Vicente, X5006CBI

  • Hospital "Dr. José Maria Cullen "

    Santa Fe, S3000EOZ

  • Centro de Investigaciones Clínicas del Litoral

    Santa Fe, S3000FWO

  • CEMEDIC - Centro de Especialidades Medicas

    Villa Luro, C1440CFD

Other trials in Argentina

Brazil38 sites

  • Hospital Felicio Rocho

    Belo Horizonte, 30110-060

  • Hospital Vera Cruz

    Belo Horizonte, 30140-062

  • Cardresearch Cardiologia Assistencial e de Pesquisas Ltda

    Belo Horizonte, 30150-240

  • CCBR - Brasília

    Brasília, 70200-730

  • ICDF - Instituto de Cardiologia do Distrito Federal

    Brasília, 70673-900

  • CECAP - Centro de Cardiologia Clínica

    Brasília, 70710-100

  • Hospital Angelina Caron

    Campina Grande do Sul, 83430-000

  • Centro Especializado em Cardiol Loema Instituto de Pesq Clin

    Campinas, 13010-001

  • IPECC - Instituto de Pesquisa Clínica de Campinas

    Campinas, 13060-080

  • CAEP - Centro Avançado de Estudos e Pesquisas Ltda.,Campinas

    Campinas, 13087-567

  • Hospital Universitário

    Canoas, 92425-900

  • IPCEM - Instituto de Pesquisa Clínica para Estudos Multicêntricos - Universidade de Caxias do Sul

    Caxias do Sul, 95070-560

  • Irmandade da Santa Casa de Misericórdia de Curitiba

    Curitiba, 80230-130

  • Hospital de Messejana Dr. Carlos Alberto Studart Gomes

    Fortaleza, 60846-190

  • Barroso e Sebba Ltda

    Goiânia, 74223-130

  • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

    Goiânia, 74605-020

  • ICM - Instituto do Coracao de Marilia

    Marília, 17515-000

  • Hospital São Vicente de Paulo

    Passo Fundo, 99010-080

  • Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90035-074

  • Centro de Pesquisas em Diabetes

    Porto Alegre, 90035-170

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, 90035-903

  • Instituto de Cardiologia Rio Grande do Sul

    Porto Alegre, 90620-001

  • Hospital Agamenon Magalhaes

    Recife, 52051-380

  • H.C.da Fac. de Medicina de Ribeirao Preto

    Ribeirão Preto, 14048-900

  • CCBR - Rio de Janeiro - BR

    Rio de Janeiro, 22271-100

  • Hospital Universitário Pedro Ernesto UERJ

    Rio de Janeiro - RJ, CEP 20551

  • Pesquisare

    Santo André, 09080-110

  • Praxis Pesquisa Médica

    Santo André, 09090-790

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, 09780-000

  • Fundacao Faculdade Regional de Medicina, Sao Jose

    São José do Rio Preto, 15090-000

  • Centro de Pesquisa Clinica - CPCLIN

    São Paulo, 01244-030

  • FGM - Clínica Paulista de Doenças Cardiovasculares

    São Paulo, 01323-000

  • CDEC BRASIL - Centro de Desenvolvimento em Estudos Clínicos Brasil

    São Paulo, 04020-060

  • Dr. Consulta

    São Paulo, 04208-002

  • CEPIC - Centro Paulista de Investigacao Clinica

    São Paulo, 04266-010

  • INCOR e Hospital das Clínicas da Universidade de São Paulo

    São Paulo, 05403-000

  • CEDOES - Diagnóstico e Pesquisa,Vitória

    Vitória, 29055-450

  • Santa Casa de Votuporanga

    Votuporanga, 15500-003

Other trials in Brazil

Poland33 sites

  • KLIMED Marek Klimkiewicz

    Bialystok, 15-765

  • Univ. Clinic Hosp, Bialystok

    Bialystok, 15276

  • American Heart of Poland Sp. z o.o.

    Bielsko-Biala, 43-316

  • NZOZ Centrum Medyczne KERmed

    Bydgoszcz, 85231

  • Polsko-Amerykanskie Kliniki Serca

    Chorzów, 32-500

  • American Heart of Poland Sp. z o.o.

    Dąbrowa Górnicza, 41-300

  • Poradnia Kardiologiczna Jaroslaw Jurowiecki

    Gdansk, 80-286

  • University Clinical Center, Gdansk

    Gdansk, 80952

  • Indywidualna Specjalistyczna Praktyka Lekarska

    Gdynia, 81-157

  • Saint Wincenty a Paulo Hosp., Cardiology Dept., Gdynia

    Gdynia, 81348

  • Szpital Zakonu Bonifratow Sp. z o.o.

    Katowice, 40-211

  • Specialistic Cardiology&Hypertension Out-patient Clin,Kielce

    Kielce, 25525

  • Leszek Bryniarski Specialized Medical Cabinet

    Krakow, 30-082

  • Krakow Specialistic Hospital of John Paul II

    Krakow, 31-202

  • SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia

    Lodz, 90-302

  • Nzoz Salus

    Lodz, 91-302

  • Individual Specialized Practice

    Lodz, 94-255

  • Lowickie Cardiology Center

    Lowicz, 99-400

  • American Heart of Poland Sp. z o.o.

    Nysa, 48-300

  • Medicome Sp. z o.o.

    Oświęcim, 32-600

  • Specialized Practice Dr. Janusz Spyra

    Ruda Śląska, 41-709

  • Centrum Medyczne Medyk

    Rzeszów, 35-055

  • Lukmed Lukasz Wozniak

    Siedlce, 08-110

  • Clinmedica Research Omc sp. z o.o. sp.k., Skierniewice

    Skierniewice, 96-100

  • KO-MED Centra Kliniczne Staszow

    Staszów, 28-200

  • The Provincial Polyclinical Hospital in Torun

    Torun, 87-100

  • American Heart of Poland Sp. z o.o.

    Tychy, 43-100

  • American Heart of Poland Sp. z o.o.

    Ustroń, 43-450

  • Central Hospital of Medical Academy, Warsaw

    Warsaw, 02-097

  • McM Polimedica

    Warsaw, 02-777

  • 4. Military Clinical Hospital with Polyclinic SP ZOZ

    Wroclaw, 50-981

  • Zgierskie Center of Cardiology MED-PRO

    Zgierz, 95-100

  • Specialist Hospital J. Dietla NZOZ Specialized Clinic "Gemini"

    Żychlin, 62-571

Other trials in Poland

Germany32 sites

  • Universitätsklinikum Aachen, AöR

    Aachen, 52074

  • Praxis Dr. Rieker, Berlin

    Berlin, 10789

  • Charité - Universitätsmedizin Berlin

    Berlin, 12200

  • Vivantes Netzwerk für Gesundheit GmbH

    Berlin, 12351

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353

  • Klinikum Bielefeld gGmbH

    Bielefeld, 33604

  • Praxis Dr. Menzel

    Dessau, 06846

  • St. Johannes Hospital Dortmund

    Dortmund, 44137

  • Städtisches Klinikum Dresden

    Dresden, 01067

  • GWT-TUD GmbH

    Dresden, 01307

  • Helios Klinikum Erfurt

    Erfurt, 99089

  • Studienzentrum Bocholderstraße

    Essen, 45355

  • ClinPhenomics GmbH & Co KG, Frankfurt

    Frankfurt, 60594

  • Universitätsmedizin Göttingen, Georg-August-Universität

    Göttingen, 37075

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum des Saarlandes

    Homburg, 66421

  • Universitätsklinikum Jena

    Jena, 07740

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Asklepios Klinik Langen-Seligenstadt GmbH

    Langen, 63225

  • Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid

    Lüdenscheid, 58515

  • Praxis Dr. Sarnighausen, Lüneburg

    Lüneburg, 21339

  • Katholisches Klinikum St. Hildegardiskrankenhaus, Mainz

    Mainz, 55131

  • Deutsches Herzzentrum München

    München, 80636

  • Kardiologische Gemeinschaftspraxis Nienburg

    Nienburg, 31582

  • Kardiologische Praxis Papenburg

    Papenburg, 26871

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • Praxis Dr. Stenzel, Riesa

    Riesa, 01587

  • Zentrum für Klinische Forschung

    Wangen, 88239

  • Josephs-Hospital Warendorf

    Warendorf, 48231

  • Petrus-Krankenhaus

    Wuppertal, 42283

Other trials in Germany

Canada30 sites

  • Brampton Cardio Pulmonary Clinic

    Brampton, Ontario, L6W 2X7

  • JBN Medical Diagnostic Services Inc.

    Burlington, Ontario, L7M 4Y1

  • Cambridge Cardiac Care Inc.

    Cambridge, Ontario, N1R 6V6

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • ViaCar Recherche Clinique Inc

    Greenfield Park, Quebec, J4V 2G8

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • Curnew Medicine Professional Corporation

    Hamilton, Ontario, L8L 0A9

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

  • Centre de Dépistage et Recherche Cardiovasculaire Rive-Sud

    Longeuil, Quebec, J4M 2X1

  • G.A. Research Associates Ltd

    Moncton, New Brunswick, E1G 1A7

  • Clinique Santé Cardio MC

    Montreal, Quebec, H1T 3Y7

  • Montreal General Hospital - McGill University Health Centre

    Montreal, Quebec, H3G 1A4

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3J1

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P6

  • M Heffernan Medicine Professional Corp.

    Oakville, Ontario, L6K 3W7

  • Kawartha Cardiology Clinical Trials

    Peterborough, Ontario, K9J 0B2

  • IUCPQ (Laval University)

    Québec, G1V 4G5

  • Centre de sante et de services sociaux de Beauce

    Saint George-de-Beauce, Quebec, G5Y 4T8

  • Heart Health Institute

    Scarborough Village, Ontario, M1B 4Z8

  • Scarborough Cardiology Research

    Scarborough Village, Ontario, M1E 5E9

  • Canadian Phase Onward Inc.

    Toronto, Ontario, M3J 2C5

  • North York Diagnostic and Cardiac Centre

    Toronto, Ontario, M6B 1N6

  • Diabetes Heart Research Centre

    Toronto, Ontario, M6G 1M2

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

  • Victoria Heart Institute Foundation

    Victoria, British Columbia, V8R 4R2

  • Mohan Babapulle Medicine Professional Medicine

    Waterloo, Ontario, N2T 0C1

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

  • Dr. Louis C.H. Yao

    York, Ontario, M9N 1W4

Other trials in Canada

China27 sites

  • Cardiovascular Institute and Fu Wai Hospital

    Beijing, 100037

  • Beijing Friendship Hospital

    Beijing, 100050

  • First Hospital of Jilin University

    Changchun, 130021

  • Hunan Provincial People's Hospital

    Changsha, 410005

  • 2nd Xiangya Hospital of Central South University

    Changsha, 410011

  • The Third Hospital of Changsha

    Changsha, 410015

  • Dongguan People's Hospital

    Dongguan, 523059

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, 350005

  • The First Afiliated Hospital, Sun Yet-sen University

    Guangzhou, 510080

  • Guangzhou First Municipal People's Hospital

    Guangzhou, 510180

  • Haikou People's Hospital

    Haikou, 570208

  • HaiNan Provincial People's Hospital

    Haikou, 570311

  • The First Affiliated Hospital of Lanzhou University

    Lanzhou, 730000

  • The Second Affiliated Hospital of Lanzhou Medical University

    Lanzhou, 730030

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, 646099

  • Nanchang University Affiliated 3rd Hospital

    Nanchang, 330008

  • First Hospital Affiliated with Nanjing Medical University

    Nanjing, 210029

  • Huashan Hospital, Fudan University

    Shanghai, 200040

  • General Hospital of Shenyang Military Region

    Shenyang, 110015

  • Shengjing Hospital of China Medical University

    Shenyang, 110072

  • Tianjin Union Medical Center Nankai University Affiliated Hospital

    Tianjin, 300121

  • Tongji Hospital, Tongji University

    Wuhan, 430030

  • Renmin Hospital of Wuhan University

    Wuhan, 430060

  • First Affiliated Hospital of Xi'an JiaoTong University

    Xi'an, 710061

  • Yanbian University Hospital

    Yanji, 133000

  • the first people hospital of Yue Yang

    Yueyang, 414000

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, 212013

Other trials in China

Netherlands23 sites

  • Ziekenhuisgroep Twente locatie Almelo

    Almelo, 7609 PP

  • BovenIJ Ziekenhuis

    Amsterdam, 1034 CS

  • Onze Lieve Vrouwe Gasthuis, Locatie West

    Amsterdam, 1061 AE

  • Amsterdam UMC Locatie VUMC

    Amsterdam, 1081HV

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091AC

  • Amsterdam UMC, Locatie AMC

    Amsterdam, 1105 AZ

  • Rode Kruis Ziekenhuis Beverwijk

    Beverwijk, 1942 LE

  • Tergooiziekenhuizen locatie Blaricum

    Blaricum, 1261 AN

  • Amphia Ziekenhuis

    Breda, 4818 CK

  • Ziekenhuis Gelderse Vallei

    Ede, 6716 RP

  • Catharina Ziekenhuis

    Eindhoven, 5623 EJ

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Zuyderland Medisch Centrum

    Heerlen, 6419 PC

  • Vasculair Onderzoek Centrum

    Hoorn, 1624 NP

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX

  • Diaconessenhuis Meppel

    Meppel, 7943 KA

  • St. Antonius ziekenhuis, locatie Nieuwegein

    Nieuwegein, 3435 CM

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GL

  • HMC Bronovo

    The Hague, 2597 AX

  • Ziekenhuis Bernhoven Uden

    Uden, 5406 PT

  • Vie Curi Medisch Centrum

    Venlo, 5912 BL

  • De Heel - Zaans Medisch Centrum

    Zaandam, 1502 DV

  • Gelre Ziekenhuis Zutphen

    Zutphen, 7207 AE

Other trials in Netherlands

Czechia21 sites

  • Poliklinika Humanitas

    Bílovec, 74301

  • Medicus Services Ltd.

    Brandys Nad, 250 01

  • Internal and Cardiology Practice, MUDr. Karel Kamenik, Brno

    Brno, 603 00

  • MUDr. Alexandra Ludkova

    Brno, 615 00

  • Vojenska nemocnice Brno

    Brno, 63600

  • Nemocnice Milosrdnych bratri

    Brno, 63900

  • Edumed s.r.o

    Broumov, 55001

  • MUDr. Jan Hubac, s.r.o. Kardiologicka ambulance

    Chrudim, 53702

  • Nemocnice ve Frydku-Mistku, prispevkova organizace

    Frýdek-Místek, 73818

  • MUDr. Ladislav Busak

    Louny, 440 01

  • Zdenek Vomacka

    Olomouc, 779 00

  • PV-Kardiologie s.r.o.

    Pardubice, 53002

  • General Faculty Hospital, Prague

    Prague, 128 08

  • University Hospital Motol

    Prague, 15006

  • Thomayer Hospital

    Praha 4 - Krc, 140 59

  • Kardio Vaclavik s.r.o.

    Přerov, 75000

  • Clinic of Cardiology, Pribram

    Příbram, 261 01

  • Hospital Trebic, p.o.

    Třebíč, 67401

  • Masaryk Hospital, Usti nad Labem

    Ústí nad Labem, 40113

  • Angiocor s.r.o

    Zlín, 76001

  • KIGE s.r.o

    Znojmo, 66902

Other trials in Czechia

Hungary17 sites

  • Lausmed Kft. Outpatient Unit of Internal Medicine

    Baja, 6500

  • Belgyogyaszati es Kardiologiai Maganrendelo

    Békéscsaba, 5600

  • Clinexpert Kft.

    Budapest, 1033

  • Gottsegen Gyorgy Hungarian Instit.of Cardiology,Budapest

    Budapest, 1096

  • Bajcsy-Zsilinszky Hospital and Clinic

    Budapest, 1106

  • Semmelweis University

    Budapest, 1122

  • Milit.Hosp.-State Health Cent.

    Budapest, 1134

  • Uzsoki Street Hospital, Budapest

    Budapest, 1145

  • Nehezlegzes Ambulancia

    Debrecen, 4027

  • Bugat Pal Hospital, Gyongyos

    Gyöngyös, 3200

  • Selye Janos Hospital Komarom

    Komárom, 2900

  • Dorottya Kanizsai Hospital

    Nagykanizsa, 8800

  • Dr. Nagy Laszlo Kardiologiai Maganrendeles

    Orosháza, 5900

  • Pecsi Tudomanyegyetem

    Pécs, 7623

  • Da Vinci Maganklinika

    Pécs, 7635

  • Fejer County Saint George University Teaching Hospital

    Székesfehérvár, 8000

  • Veszpremi Sziv es Egeszseg Centrum

    Veszprém, 8200

Other trials in Hungary

Mexico15 sites

  • Hospital Cardiologica Aguascalientes

    Aguascalientes, 20230

  • Centro de Investigacion Biomedica y Farmaceutica, S.C.

    Distrito Federal, 03100

  • Unidad de Investigacion Clinica Cardiometabolica de Occident

    Guadalajara, 44150

  • Diseño y Planeación en Investigación Médica SC

    Guadalajara, 44656

  • Cardiologia Clinica e Intervencionista

    Guadalajara, 44670

  • Centro de Investigación Clinica Acelerada, S.C.

    México, 07020

  • CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc

    México, 11650

  • Instituto Nacional de Cardiologia Ignacio Chavez

    Mexico City, 14080

  • Instituto Cardiovascular de Monclova, S de RL de CV

    Monclova, 25750

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Nuevo León, 64460

  • Centro Integral Medico SJR S.C.

    San Juan del Río, 76800

  • Cardioarritmias e Investigación S.C

    San Luis Potosí City, 78213

  • Centro de Investigacion Cardiovascular y Metabolica

    Tijuana, 22500

  • Centro de Investigacion Medica Alberto Bazzoni S.A. de C.V.

    Torreón, 27000

  • Hospital Dr Angel Leano

    Zapopan, 45200

Other trials in Mexico

India14 sites

  • Doctor Jivraj Mehta Smarak Health Foundation

    Ahmedabad, 380007

  • Narayana Institute of Cardiac Sciences

    Bangalore, 560099

  • Rajarajeswari Medical College

    Bengaluru, 560074

  • Madras Medical Mission,

    Chennai, 600 037

  • Apollo Speciality Hospital

    Chennai, 600035

  • Kamalnayan Bajaj Hospital

    Chhatrapati Sambhajinagar, 431 005

  • Medanta-The Medicity

    Gūrgaon, 122001

  • B.M. Birla Heart research Centre

    Kolkata, 700027

  • Vijan Cardiac and Critical Care Centre

    Nashik, 422005

  • Siddhi Hospital

    Nashik, 422007

  • Batra Hospital and Medical Research Centre

    New Delhi, 110 062

  • GB Pant Hospital

    New Delhi, 110002

  • Fortis Escorts Heart Institute

    New Delhi, 110025

  • Sir Gangaram Hospital

    New Delhi, 110060

Other trials in India

South Korea12 sites

  • Dong-A University Hospital

    Busan, 602-715

  • Inje University Busan Paik Hospital

    Busan, 614-735

  • Chungbuk National University Hospital

    Cheongju-si, 361-771

  • Chungnam National University Hospital

    Daejeon, 35015

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Korea University Guro Hospital

    Seoul, 08308

  • Seoul National University Bundang Hospital

    Sungnam, 463-707

  • Wonju Severance Christian Hosp

    Wŏnju, 26426

Other trials in South Korea

Spain12 sites

  • Hospital Quiron. I.C.U.

    Barcelona, 08023

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08026

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, 30120

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital La Paz

    Madrid, 28046

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Complejo Hospitalario Universitario de Orense

    Ourense, 32005

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003

Other trials in Spain

Belgium10 sites

  • AZ Sint-Jan Brugge

    Bruges, 3000

  • C.H.U. de Charleroi

    Charleroi, 6000

  • AZ Sint-Blasius

    Dendermonde, 9200

  • Ziekenhuis Oost-Limburg - Campus Sint-Jan

    Genk, 3600

  • AZ Sint-Lucas - Campus Sint Lucas

    Ghent, 9000

  • Grand Hôpital de Charleroi

    Gilly, 6060

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500

  • La Louvière - UNIV CHU Tivoli

    La Louvière, 7100

  • UZ Leuven

    Leuven, 3000

  • AZ Sint-Maarten

    Mechelen, 2800

Other trials in Belgium

France10 sites

  • HOP de Bayonne

    Bayonne, 64100

  • HOP Jean Minjoz

    Besançon, 25030

  • HOP Louis Pradel

    Bron, 69500

  • HOP Côte de Nacre

    Caen, 14033

  • HOP Arnaud de Villeneuve

    Montpellier, 34295

  • HOP La Pitié Salpêtrière

    Paris, 75651

  • Centre Hospitalier de Pau

    Pau, 64046

  • HOP Haut-Lévêque

    Pessac, 33600

  • HOP Rangueil

    Toulouse, 31059

  • INS Louis Mathieu

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Italy10 sites

  • Azienda Ospedaliera G. Rummo

    Benevento, 82100

  • ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII

    Bergamo, 24127

  • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

    Cona (FE), 44124

  • Ospedale della Val di Chiana Santa Margherita

    Cortona (AR), 52040

  • Centro Cardiologico Monzino-IRCCS

    Milan, 20138

  • Azienda Ospedaliera Universitaria "Federico II"

    Naples, 80131

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56126

  • Umberto I Pol. di Roma-Università di Roma La Sapienza

    Roma, 00161

  • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

    Roma, 00189

  • Azienda Servizi Sanitari 1 Triestina

    Trieste, 34128

Other trials in Italy

Australia9 sites

  • SA-Heart Ashford Specialist Centre

    Ashford, South Australia, 5035

  • The Northern Hospital

    Epping, Victoria, 3076

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Heart and Vascular Research

    Fullarton, South Australia, 5063

  • University Hospital Geelong

    Geelong, Victoria, 3220

  • CORE Research Group

    Milton, Queensland, 4064

  • John Hunter Hospital

    New Lambton Heights, New South Wales, 2305

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Mater Hospital Brisbane

    South Brisbane, Queensland, 4101

Other trials in Australia

United Kingdom9 sites

  • Barnet General Hospital

    Barnet, EN5 3DJ

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • Park & St Francis Surgery

    Eastleigh, SO53 4ST

  • Wycombe General Hospital

    High Wycombe, HP11 2TT

  • Glenfield Hospital

    Leicester, LE3 9QP

  • St Bartholomew's Hospital

    London, EC1A 7BE

  • Luton and Dunstable University Hospital

    Luton, LU4 0DZ

  • St Mary's Hospital

    Newport, PO30 5TG

  • Morriston Hospital

    Swansea, SA6 6NL

Other trials in United Kingdom

About this study

Official title: A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.

Conditions
Heart Failure
Being tested
Empagliflozin, Placebo
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmpagliflozinDrug

    Also called JARDIANCE, JARDIANZ, GIBTULIO

    once daily

  • PlaceboDrug

    once daily

Study groups in NCT03057977
Study groupRoleWhat they receive
EmpagliflozinExperimentalNot described
Receives: Drug: Empagliflozin
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)

    Time to the first event of adjudicated cardiovascular (CV) death or adjudicated hospitalisation for heart failure (HHF). The incidence rate per 100 patient years (100 * number of patients with event /time at risk [years]) is presented. With time at risk [year] calculated as: Sum of time at risk [days] over all patients in a treatment group / 365.25.

    Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

    Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.

    Measured: From randomisation until completion of the planned treatment period, up to 1040 days.

Secondary outcomes (9)

  1. Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent)

    Reported is the total number of HHF events (first and recurrent) which occurred.

    All data up to the end of the planned treatment period (including the data after the end of treatment for patients not completing the treatment period as planned) from all randomised patients was used.

    Measured: From randomisation until completion of the planned treatment phase, up to 1040 days.

  2. eGFR (CKD-EPI) cr Slope of Change From Baseline

    Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) [mL/min/1.73m2] slope of change from baseline.

    Available on-treatment change-from-baseline data were to be used. Patients without on-treatment data after randomisation were not to be included in this analysis. Slope represents the long term effect on eGFR.

    Timepoints after baseline were included in calculation of slope of change from baseline. Descriptive statistic (mean(standard error)) is reported.

    Measured: Assessed at baseline, week 4, 12, 32, 52, 76, 100, 124, 148 and at end of treatment (EOT), up to 1040 days.

  3. Time to First Event in Composite Renal Endpoint: Chronic Dialysis, Renal Transplant or Sustained Reduction of eGFR(CKD-EPI)cr

    Time to the first event in the composite renal endpoint: chronic dialysis (with a frequency of twice per week or more for at least 90 days), renal transplant, or sustained reduction in Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr).

    The incidence rate per 100 patient years (100 * number of patients with event /time at risk [years]) is presented. With time at risk [year] calculated as: Sum of time at risk [days] over all patients in a treatment group / 365.25.

    Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

    Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.

    Measured: From randomisation until completion of the planned treatment period, up to 1040 days.

  4. Time to First Adjudicated Hospitalisation for Heart Failure (HHF)

    Time to first adjudicated Hospitalisation for Heart Failure (HHF). The incidence rate per 100 patient years (100 * number of patients with event /time at risk [years]) is presented. With time at risk [year] calculated as: Sum of time at risk [days] over all patients in a treatment group / 365.25. Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

    Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.

    Measured: From randomisation until completion of the planned treatment period, up to 1040 days.

  5. Time to Adjudicated Cardiovascular (CV) Death

    Time to adjudicated CV (Cardiovascular) death. The incidence rate (patients with events per 100 person years at risk) is reported.

    The incidence rate per 100 patient years (100 * number of patients with event /time at risk [years]) is presented. With time at risk [year] calculated as: Sum of time at risk [days] over all patients in a treatment group / 365.25.

    Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

    Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.

    Measured: From randomisation until completion of the planned treatment period, up to 1040 days.

  6. Time to All-cause Mortality

    Time to all-cause mortality. The incidence rate (patients with events per 100 person years at risk) is reported.

    The incidence rate per 100 patient years (100 * number of patients with event /time at risk [years]) is presented. With time at risk [year] calculated as: Sum of time at risk [days] over all patients in a treatment group / 365.25.

    Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

    Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.

    Measured: From randomisation until completion of the planned treatment period, up to 1040 days.

  7. Time to Onset of Diabetes Mellitus (DM)

    Time to onset of DM (Glycated haemoglobin (HbA1c) ≥6.5% or as diagnosed by the investigator) in patients with pre-DM (no history of DM and no HbA1c ≥6.5% before treatment, and a pre-treatment HbA1c value of 5.7 to <6.5%). The incidence rate (patients with events per 100 person years at risk) is reported.

    The incidence rate per 100 patient years (100 * number of patients with event /time at risk [years]) is presented. With time at risk [year] calculated as: Sum of time at risk [days] over all patients in a treatment group / 365.25.

    Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

    Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.

    Measured: From randomisation until completion of the planned treatment period, up to 1040 days.

  8. Change From Baseline in KCCQ (Kansas City Cardiomyopathy Questionnaire) Clinical Summary Score at Week 52

    Change from baseline in KCCQ (Kansas City cardiomyopathy questionnaire) clinical summary score at Week 52. The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, selfefficacy, and quality of life in patients with Heart Failure. The KCCQ-clinical summary score comprises the following domains: Symptom frequency, symptom burden and physical limitation. The score is calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.

    For patients who died, a worst score (score of 0) is imputed at all subsequent scheduled visits after the date of death.

    Standard error is adjusted standard error. Change from baseline in KCCQ-score at week 52 was modeled using a MMRM with visit (week 12, 32 and 52) as repeated measures, adjusted mean (standard error) at week 52 is reported.

    Measured: Assessed at baseline, week 12, week 32 and week 52.

  9. Number of All-cause Hospitalizations (First and Recurrent)

    Number of all-cause hospitalizations (first and recurrent).

    Measured: From randomisation until completion of the planned treatment phase, up to 1040 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2017
  2. Study start6 Mar 2017
  3. Primary completion1 May 2020
  4. Study completion28 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3,730 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03057977
Sponsor's protocol ID
1245.121
Other IDs
2016-002280-34, 2016
Status last verified
Apr 2021
First submitted
16 Feb 2017
Last updated
18 May 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Packer M, Ferreira JP, Butler J, Filippatos G, Januzzi JL Jr, Gonzalez Maldonado S, Panova-Noeva M, Pocock SJ, Prochaska JH, Saadati M, Sattar N, Sumin M, Anker SD, Zannad F. Reaffirmation of Mechanistic Proteomic Signatures Accompanying SGLT2 Inhibition in Patients With Heart Failure: A Validation Cohort of the EMPEROR Program. J Am Coll Cardiol. 2024 Nov 12;84(20):1979-1994. doi: 10.1016/j.jacc.2024.07.013. Epub 2024 Aug 31.

    PubMed 39217550

  • Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

    PubMed 38770818

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Empagliflozin in people with Heart Failure, run by Boehringer Ingelheim at 520 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 520 sites in United States, Japan, Argentina, Brazil, Poland and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) (time frame: From randomisation until completion of the planned treatment period, up to 1040 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03057977, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.

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