Heart FailurePhase 3NCT03057951
EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)
A Phase 3 study testing Empagliflozin in people with Heart Failure, run by Boehringer Ingelheim at 619 sites in 23 countries.
Trial summary
This is a study in adults with chronic heart failure. People with chronic heart failure may need to be hospitalised for their condition. Some people with chronic heart failure may eventually die from their condition. 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
- 5,988 participants
- Where
- 619 sitesin 23 countries
- Study dates
- 2 Mar 2017to 26 Apr 2021
- 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 preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
- Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1
- Stable dose of oral diuretics, if prescribed
- 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 (Heart Failure)
- Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
- Symptomatic hypotension and/or a SBP < 100 mmHg
- Indication of liver disease,
Show all 13Show fewer
- Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr 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 trial
- 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 may apply
Trial locations and contacts
619 sites in 23 countries.
619 sites in 23 countries
United States135 sites
Capital Cardiology Associates, PC
Albany, New York, 12211
Alpena General Hospital
Alpena, Michigan, 49707
Anne Arundel Medical Center
Annapolis, Maryland, 21401
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Northwest Heart Clinical Research, LLC
Arlington Heights, Illinois, 60005
Asheville Cardiology Associates
Asheville, North Carolina, 28803
Grady Clinical Research Center
Atlanta, Georgia, 30303
Seton Heart Institute
Austin, Texas, 78705
Maryland Cardiovascular Specialists
Baltimore, Maryland, 21229
MedStar Health Research Institute
Baltimore, Maryland, 21237
Metropolitan Cardiovascular Consultants
Beltsville, Maryland, 20705
Deaconess Billings Clinic Research Center
Billings, Montana, 59101
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Integrated Heart Care
Boca Raton, Florida, 33434
Grace Research, LLC
Bossier City, Louisiana, 71111
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Bozeman Health Clinical Research
Bozeman, Montana, 59718
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
Lowcountry Center for Veterans Research
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
Mount Sinai Hospital
Chicago, Illinois, 60608
Southeast Clinical Research, LLC
Chiefland, Florida, 32626
Morton Plant Mease Health Care
Clearwater, Florida, 33756
VA Northeast Ohio Healthcare System
Cleveland, Ohio, 44104-1702
Palmetto Health
Columbia, South Carolina, 29203
Columbus Regional Research Institute
Columbus, Georgia, 31904
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
Cardiology Consultants of Danville, Inc
Danville, Virginia, 24541
Accel Research Sites
DeLand, Florida, 32720
Iowa Heart Center
Des Moines, Iowa, 50314
Doylestown Health Cardiology
Doylestown, Pennsylvania, 18901
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, 46514
Alpine Research Organization
Farmington, Utah, 84025
Integrative Research Associates
Fort Lauderdale, Florida, 33312
University of North Texas Health Science Center
Fort Worth, Texas, 76107
University of California San Francisco
Fresno, California, 93701
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
Clinical Research of Gastonia
Gastonia, North Carolina, 28054
The Stern Cardiovascular Center
Germantown, Tennessee, 38138
Nebraska Heart Institute
Grand Island, Nebraska, 68803
East Mountain Medical Associates, PC
Great Barrington, Massachusetts, 01230
Cardiology Associates of Bellin Health
Green Bay, Wisconsin, 54301
Angiocardiac Care of Texas
Houston, Texas, 77025
The Methodist Hospital
Houston, Texas, 77030
Biopharma Informatic, Inc. Research Center
Houston, Texas, 77084
Heart Center Research, LLC
Huntsville, Alabama, 35801
St. Francis Medical Group-Indiana Heart Physicians, Inc
Indianapolis, Indiana, 46237
Nature Coast Clinical Research
Inverness, Florida, 34452
Jackson Heart Clinic, P.A.
Jackson, Mississippi, 39216
Apex Cardiology/ Research Associates of Jackson
Jackson, Tennessee, 38301
East Coast Institute for Research, LLC
Jacksonville, Florida, 32216
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Lycoming Internal Medicine, Inc
Jersey Shore, Pennsylvania, 17740
Richard M Kastelic and Associates
Johnstown, Pennsylvania, 15905
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Private Practice Leadership, LLC
Katy, Texas, 77493
La Mesa Cardiac Center
La Mesa, California, 91942
Purushotham, Akther & Roshan Kotha, MD Inc.
La Mesa, California, 91942
Healthcare Partners LLC
Las Vegas, Nevada, 89109
Palm Research Center
Las Vegas, Nevada, 89128
Cardiovascular Group PC
Lawrenceville, Georgia, 30046
Clinical Trials of America, Inc
Lenoir, North Carolina, 28645
Maine Research Associates
Lewiston, Maine, 04240
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
Norton Heart Specialists
Louisville, Kentucky, 40202
Meriter Wisconsin Heart
Madison, Wisconsin, 53713
Garden State Heart Care, PC
Manalapan, New Jersey, 07726
Carient Heart and Vascular
Manassas, Virginia, 20109
North Shore University Hospital
Manhasset, New York, 11030
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
Elite Clinical Research
Miami, Florida, 33144
Cardiovascular Research Center of South Florida
Miami, Florida, 33173
Clinical Trials of America, LLC
Monroe, Louisiana, 71201
Advocate Health and Hospitals Corporation
Naperville, Illinois, 60540
Long Island Cardiovascular Consultants
New Hyde Park, New York, 11042
LSU Health Sciences Center
New Orleans, Louisiana, 70112
Mount Sinai - PRIME
New York, New York, 10025
Harlem Cardiology
New York, New York, 10035
Captain James A. Lovell Federal Health Care Center
North Chicago, Illinois, 60064
Valley Clinical Trials, Inc.
Northridge, California, 91325
South Oklahoma Heart Research Group
Oklahoma City, Oklahoma, 73135
University of California Irvine
Orange, California, 92865
Orlando Health Inc.
Orlando, Florida, 32806
Peninsula Research, Inc.
Ormond Beach, Florida, 32174
Research Integrity, LLC
Owensboro, Kentucky, 42303
MD Medical Research
Oxon Hill, Maryland, 20745
CHI Health Midlands
Papillion, Nebraska, 68046
McLaren Northern Michigan Hospital
Petoskey, Michigan, 49770
Baylor Scott and White Health
Plano, Texas, 75024
Reid Hospital
Richmond, Indiana, 47374
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
Medical College of Virginia Hospitals
Richmond, Virginia, 23298
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
Laurelton Heart Specialist, PC
Rosedale, New York, 11422
Clearwater Cardiovascular Consultants
Safety Harbor, Florida, 34695
Regions Hospital
Saint Paul, Minnesota, 55101
Salem VA Medical Center
Salem, Virginia, 24153
University of California San Francisco
San Francisco, California, 94143
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Saratoga Clinical Research, LLC
Saratoga Springs, New York, 12866
Meridian Clinical Research, LLC
Savannah, Georgia, 31406
Virginia Mason Medical Center
Seattle, Washington, 98101
Sanford Research
Sioux Falls, South Dakota, 57104
Beacon Medical Group Clinical Research
South Bend, Indiana, 46601
Northwell Health
Southampton, New York, 11968
Palmetto Research Center, LLC
Spartanburg, South Carolina, 29302
Saint Louis University
St Louis, Missouri, 63110
St. Louis Center for Clinical Research
St Louis, Missouri, 63128
St. Louis Heart and Vascular, P.C.
St Louis, Missouri, 63136
Stony Brook University Medical Center
Stony Brook, New York, 11794
University of South Florida
Tampa, Florida, 33606
Advent Health Medical Group
Tampa, Florida, 33613
CHEAR Center LLC
The Bronx, New York, 10455
Cardiac Care and Vascular Medicine, PLLC
The Bronx, New York, 10469
University of California
Torrance, California, 90502
Atlanta Heart Specialists, LLC
Tucker, Georgia, 30084
Orange County Research Center
Tustin, California, 92780
Blue Coast Cardiology
Vista, California, 92083
Aspirus Research Institute
Wausau, Wisconsin, 54401
York Hospital, WellSpan Health
York, Pennsylvania, 17403
Japan65 sites
Kasugai Municipal Hospital
Aichi, Kasugai, 486-8510
Japanese Red Cross Nagoya Daini Hospital
Aichi, Nagoya, 466-8650
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
Steel Memorial Yawata Hospital
Fukuoka, Kitakyushu, 805-8508
Japan Community Health Care Organization Kyushu Hospital
Fukuoka, Kitakyushu, 806-8501
Shirakawa Kosei General Hospital
Fukushima, Shirakawa, 961-0005
Ogaki Municipal Hospital
Gifu, Ogaki, 503-8502
Chuno Kosei Hospital
Gifu, Seki, 501-3802
Fukuyama City Hospital
Hiroshima, Fukuyama, 721-8511
Shobara Red Cross Hospital
Hiroshima, Shobara, 727-0013
Matsuda Cardiovascular Clinic
Hokkaido, Sapporo, 003-0026
Teine Keijinkai Clinic
Hokkaido, Sapporo, 006-0811
Tomakomai City Hospital
Hokkaido, Tomakomai, 053-8567
Otaru Kyokai Hospital
Hokkaido,Otaru, 047-8510
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
Tokushukai Koga General Hospital
Ibaraki, Koga, 306-0041
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
Sekishinkai Second Kawasaki Saiwai Clinic
Kanagawa, Kawasaki, 212-0021
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
Omi Medical Center
Kusatsu, 525-8585
Uji-Tokushukai Medical Center
Kyoto, Uji, 611-0041
Sendai Kousei Hospital
Miyagi, Sendai, 980-0873
Sendai Tokushukai Hospital
Miyagi, Sendai, 981-3131
National Hospital Organization Sendai Medical Center
Miyagi, Sendai, 983-8520
Miyazaki Medical Association Hospital
Miyazaki, Miyazaki, 880-2102
Hokushin General Hospital
Nagano, Nakano, 383-8505
Nagasaki Medical Center
Nagasaki, Omura, 856-8562
Oita Medical Center
Oita, Oita, 870-0263
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
Hokusetsu General Hospital
Osaka, Takatsuki, 569-8585
San-Ai Hospital
Saitama, Saitama, 338-0837
Kosekai Iwatsuki-minami Hospital
Saitama, Saitama, 339-0033
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
Argentina39 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
Instituto Cardiovascular de Buenos Aires
Ciudad Autonoma Buenos Aires, C1428ART
Glenny Corp. S.A. Bioclinica Argentina
Ciudad Autonoma Buenos Aires, C1430CKE
Centro Médico Viamonte
Ciudad Autonoma de Bs As, C1120AAC
Sanatorio Güemes
Ciudad Autónoma de Bs As, C1180AAX
Consultorios Asociados de Endocrinología e Invest Clínica
Ciudad Autonoma de BuenosAires, C1425AGC
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
Clinica Privada Colombo- Fundacion Clinica Colombo
Córdoba, X5002AOQ
Instituto Médico DAMIC S.R.L.
Córdoba, X5003DCE
Hospital Privado
Córdoba, X5016KEH
Clinica Coronel Suarez SA
Coronel Suárez, B7540GHD
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
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
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
Clinica Mayo
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
Clínica Olivos
Vicente López, 1602
CEMEDIC - Centro de Especialidades Medicas
Villa Luro, C1440CFD
Brazil37 sites
FGM - Clínica Paulista de Doenças Cardiovasculares
Bela Vista, 01323-000
Hospital Felicio Rocho
Belo Horizonte, 30110-060
Hospital Vera Cruz
Belo Horizonte, 30140-092
L2IP -Instituto de Pesquisas Clínicas Ltda.
Brasília, 70200-730
ICDF - Instituto de Cardiologia do Distrito Federal
Brasília, 70673-900
CECAP - Centro de Cardiologia Clínica
Brasília, 70710-100
Irmandade da Santa Casa de Misericordia de Curitiba
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
Via Medica
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
Hospital Universitário Pedro Ernesto UERJ
Rio de Janeiro, 20551-030
CCBR - Rio de Janeiro - BR
Rio de Janeiro, 22271-100
Cardresearch Cardiologia Assistencial e de Pesquisas Ltda
Santa Efigênia, 30150-240
Pesquisare
Santo André, 09080-110
Praxis Pesquisa Médica
Santo André, 09090-790
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, 09780-000
Hospital de Base - Fac Med de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000
Centro de Pesquisa Clinica - CPCLIN
São Paulo, 01228-200
CDEC BRASIL - Centro de Desenvolvimento em Estudos Clínicos Brasil
São Paulo, 04020-060
CEPIC - Centro Paulista de Investigacao Clinica
São Paulo, 04266-010
Dr. Consulta
São Paulo, 05016-090
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
Germany35 sites
Universitätsklinikum Aachen, AöR
Aachen, 52074
Praxis Dr. Rieker, Berlin
Berlin, 10789
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 10967
Charité - Universitätsmedizin Berlin
Berlin, 12203
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 12351
Charité - Universitätsmedizin Berlin
Berlin, 13353
Klinikum Bielefeld gGmbH
Bielefeld, 33604
Augusta-Kranken-Anstalt gGmbH
Bochum, 44791
Praxis Dr. Menzel
Dessau, 06846
St. Johannes Hospital Dortmund
Dortmund, 44137
Städtisches Klinikum Dresden
Dresden, 01067
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Helios Klinikum Erfurt
Erfurt, 99089
Studienzentrum Bocholderstraße
Essen, 45355
ClinPhenomics GmbH & Co KG, Frankfurt
Frankfurt, 60596
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, 37075
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 Mainz
Mainz, 55131
Gemeinschaftspraxis Drs. Kohler/Salbach, Mannheim
Mannheim, 68165
Deutsches Herzzentrum München
München, 80636
Gemeinschaftspraxis Dres Haggenmiller/Jeserich
Nuremberg, 90402
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
Kardiologische Praxis, Wermsdorf
Wermsdorf, 04779
Petrus-Krankenhaus
Wuppertal, 42283
Poland35 sites
Univ. Clinic Hosp, Bialystok
Bialystok, 15-276
KLIMED Marek Klimkiewicz
Bialystok, 15-765
ClinicMed Badurski i wspolnicy Spolka Jawna, Bialystok
Bialystok, 15-879
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, 80-952
Indywidualna Specjalistyczna Praktyka Lekarska
Gdynia, 81-157
NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog.
Gdynia, 81-423
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
ETG Lodz
Lodz, 90-302
Nzoz Salus
Lodz, 91-002
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
NZOZ HEUREKA, Piaseczno
Piaseczno, 05-500
Specialized Practice Dr. Janusz Spyra
Ruda Śląska, 41-709
Centrum Medyczne Medyk
Rzeszów, 35-055
Lukmed Lukasz Wozniak
Siedlce, 08-110
ETG 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
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, 02-097
ETG Warszawa
Warsaw, 02-793
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
Canada34 sites
Brampton Cardio Pulmonary Clinic
Brampton, Ontario, L6W 2X7
Brampton Research Associates
Brampton, Ontario, L6Z 4N5
ViaCar Recherche Clinique Inc
Brossard, Quebec, J4Z 2K9
JBN Medical Diagnostic Services Inc.
Burlington, Ontario, L7M 4Y1
Cambridge Cardiac Care Inc.
Cambridge, Ontario, N1R 6V6
Dr. Saul Vizel
Cambridge, Ontario, N1R 7R1
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Cardiovascular Contract Research Organization LTD
Greater Sudbury, Ontario, P3E 3Y9
ViaCar Recherche Clinique Inc
Greenfield Park, Quebec, J4V 2G8
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
Curnew Medicine Professional Corporation
Hamilton, Ontario, L8L 0A9
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
University Hospital (LHSC)
London, Ontario, N6A 5A5
Centre de Dépistage et Recherche Cardiovasculaire Rive-Sud
Longeuil, Quebec, J4M 2X1
G.A. Research Associates Ltd
Moncton, New Brunswick, E1G 1A7
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
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
PACE (Partners in Advanced Cardiac Evaluation)
Newmarket, Ontario, L3Y 2P6
Medical Arts Health Research Group
North Vancouver, British Columbia, V7M 2H4
M Heffernan Medicine Professional Corp.
Oakville, Ontario, L6K 3W7
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, K9J 0B2
IUCPQ (Laval University)
Québec, G1V 4G5
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Heart Health Institute
Scarborough Village, Ontario, M1B 4Z8
Scarborough Cardiology Research
Scarborough Village, Ontario, M1E 5E9
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 0K2
North York Diagnostic and Cardiac Centre
Toronto, Ontario, M6B 1N6
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 1B2
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
Czechia30 sites
Poliklinika Humanitas
Bílovec, 74301
Internal and Cardiology Practice, MUDr. Karel Kamenik, Brno
Brno, 603 00
MUDr. Alexandra Ludkova
Brno, 615 00
University Hospital Brno
Brno, 625 00
Vojenska nemocnice Brno
Brno, 63600
Nemocnice Milosrdnych bratri
Brno, 63900
Fakultni nemocnice u sv. Anny v Brne
Brno, 656 91
Univ.Hosp U Svate Anny, I.Internal Clinic-Cardiology,Brno
Brno, 65691
Edumed s.r.o
Broumov, 55001
MUDr. Jan Hubac, s.r.o. Kardiologicka ambulance
Chrudim, 53702
Hospital Frydek Mistek
Frýdek-Místek, 73818
Nemocnice Havlickuv Brod p.o.
Havlíčkův Brod, 580 22
Gepamed s.r.o., Pulm. Outpat. Office, Hradec Kralove
Hradec Králové, 50002
KardioLouny s.r.o.
Louny, 440 01
InterKardioML s.r.o.
Mariánské Lázně, 353 01
Zdenek Vomacka
Olomouc, 779 00
PV-Kardiologie s.r.o.
Pardubice, 53002
Vseobecna fakultni nemocnice V Praze
Prague, 128 00
Institute for Clinical and Experimental Medicine
Prague, 140 21
University Hospital Motol
Prague, 15006
Corintez s.r.o.
Prague, 158 00
University Thomayer's Hospital
Praha 4 - Krc, 140 59
Kardio Vaclavik s.r.o.
Přerov, 75000
Nemocnice Trebic p.o.
Třebíč, 674 01
Kardiologicka ambulance
Třemošná, 33011
Kardiologicka ambulance MUDr. Ferkl s.r.o.
Trutnov, 541 01
Clinical Trials Services s.r.o
Uherské Hradiště, 68601
Cardiology Private Practice
Uničov, 783 91
Angiocor s.r.o
Zlín, 76001
KIGE s.r.o
Znojmo, 66902
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, 110016
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
Hungary20 sites
Lausmed Kft. Outpatient Unit of Internal Medicine
Baja, 6500
Belgyogyaszati es Kardiologiai Maganrendelo
Békéscsaba, 5600
Budai Irgalmasrendi Korhaz
Budapest, 1023
Clinexpert Kft.
Budapest, 1033
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
University Debrecen Hospital
Debrecen, 4032
Bugat Pal Hospital, Gyongyos
Gyöngyös, 3200
Studium Egeszseghaz Kft.
Kalocsa, 6300
Selye Janos Hospital Komarom
Komárom, 2921
Dorottya Kanizsai Hospital
Nagykanizsa, 8800
Medifarma-98 Kft.
Nyíregyháza, 4400
Dr. Nagy Laszlo Kardiologiai Maganrendeles
Orosháza, 5900
University of Pecs
Pécs, 7624
Da Vinci Private Clinic
Pécs, 7635
Fejer County Saint George University Teaching Hospital
Székesfehérvár, 8000
Veszpremi Sziv es Egeszseg Centrum
Veszprém, 8200
Netherlands20 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
Maastricht University
Maastricht, 6229 HX
Diaconessenhuis Meppel
Meppel, 7943 KA
St. Antonius ziekenhuis, locatie Nieuwegein
Nieuwegein, 3435 CM
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GL
Franciscus Gasthuis
Rotterdam, 3045 PM
De Heel - Zaans Medisch Centrum
Zaandam, 1502 DV
Gelre Ziekenhuis Zutphen
Zutphen, 7207 AE
India15 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, 600006
Kamalnayan Bajaj Hospital
Chhatrapati Sambhajinagar, 431 005
Medanta-The Medicity
Gūrgaon, 122001
GNRC Hospital
Guwahati, 781006
B.M. Birla Heart research Centre
Kolkata, 700027
Vijan Cardiac and Critical Care Centre
Nashik, 422005
Siddhi Hospital
Nashik, 422007
GB Pant Hospital
New Delhi, 110002
Fortis Escorts Heart Institute
New Delhi, 110025
Sir Gangaram Hospital
New Delhi, 110060
Batra Hospital and Medical Research Centre
New Delhi, 110062
Mexico14 sites
Hospital Cardiologica Aguascalientes
Aguascalientes, 20230
Centro de Investigacion Biomedica y Farmaceutica, S.C.
Distrito Federal, 03100
Hospital Ramon Garibay
Guadalajara, 44100
Diseño y Planeación en Investigación Médica SC
Guadalajara, 44130
Unidad de Investigacion Clinica Cardiometabolica de Occident
Guadalajara, 44150
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, C.P. 11650
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
Romania14 sites
Spitalul Clinic De Urgenta "Prof. Dr. Agrippa Ionescu"
Baloteşti, 077015
C.M.D.T.A. NEOMED, Brasov
Brasov, 500283
CMDTA Washington, Bucharest
Bucharest, 011794
Spitalul Clinic Colentina
Bucharest, 020125
Emergency Clinical Hospital 'Sf. Panteliomon'
Bucharest, 021659
Emergency University Hospital, Bucharest
Bucharest, 022328
Prof.C.C.Iliescu Hospital, National Institute of Cardiology
Bucharest, 022328
Emergency University Hospital, Bucharest
Bucharest, 050098
Spitalul Clinic "Prof. Dr. Theodor Burghele"
Bucharest, 050659
Clinica Medicala Data Plus SRL
Bucharest, 10192
S.C Cardiomed S.R.L
Craiova, 200505
Spital Judetean Deva
Deva, 330084
S.C Medicali's S.R.L
Timișoara, 300043
Spitalul Clinic Judetean de Urgenta, Timisoara
Timișoara, 300723
Australia13 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Adelaide Medical Research
Ashford, South Australia, 5035
Flinders Medical Centre
Bedford Park, South Australia, 5042
The Northern Hospital
Epping, Victoria, 3076
Peninsula Private Hospital
Frankston, Victoria, 3199
Heart and Vascular Research
Fullarton, South Australia, 5063
University Hospital Geelong
Geelong, Victoria, 3220
Pendlebury Research
Kotara, New South Wales, 2289
CORE Research Group
Milton, Queensland, 4064
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Mount Hospital
Perth, Western Australia, 6000
Gold Coast University Hospital
Southport, Queensland, 4215
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Colombia13 sites
Corazon IPS S.A.S.
Barranquilla, 080003
Centro de Reumatologia y Ortopedia SAS, Barranquilla
Barranquilla, 080020
IPS Centro Cientifico Asistencia
Barranquilla, 080020
Endocare Research Institute
Bogotá, 111611
CardioColombia S.A.S.
Bogota D.C, 111611
IPS Centro Medico Julián Coronel S.A.
Cali, 760002
Fundación Valle del Lili
Cali, 760032
Centro de Investigaciones Clinicas S.A.S
Cali, 760036
Centro de Diagnostico Cardilogico
Cartagena, 130001
Centro cardiovascular Aristides
Cartagena, 130010
Fundación Cardiovascular de Colombia
Floridablanca, 681002
Asociacion IPS Medicos Internistas de Caldas
Manizales, 170004
Promotora Medica Las Americas SA
Medellín, 050025
Italy13 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, 52040
Milano Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, 20122
Centro Cardiologico Monzino-IRCCS
Milan, 20138
Azienda Ospedaliera Universitaria "Federico II"
Naples, 80131
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126
AOU Policlinico Umberto I
Roma, 00161
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma, 00189
Istituto Clinico Humanitas
Rozzano (MI), 20089
IRCCS Gruppo Multimedica
Sesto San Giovanni (MI), 20099
Azienda Servizi Sanitari 1 Triestina
Trieste, 34128
South Africa13 sites
Cardiology Clinical Research
Alberton, 1449
Iatros International
Bloemfontein, 9301
Universitas Hospital Cardiology Research
Bloemfontein, 9301
Corbod Research
Cape Town, 7500
TREAD Research
Cape Town, 7500
Tiervlei Trial Centre
Cape Town, 7530
Excellentis Clinical Trials
George, 6529
Clinresco
Johannesburg, 1619
Chris Hani Baragwanath Hospital: Cardiology Department
Johannesburg, 1862
MERC Research
Kempton Park, 1619
Into Research
Pretoria, 181
Dr JM Engelbrecht
Somerset West, 7130
Clinical Projects Research
Worcester, 6850
South Korea13 sites
Inje University Busan Paik Hospital
Busan, 47392
Dong-A University Hospital
Busan, 49201
Chungbuk National University Hospital
Cheongju-si, 28644
Chungnam National University Hospital
Daejeon, 35015
Chonnam National University Hospital
Gwangju, 61469
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
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
Wonju Severance Christian Hosp
Wŏnju, 26426
Spain13 sites
Hospital Quiron. I.C.U.
Barcelona, 08023
Hospital Santa Creu i Sant Pau
Barcelona, 08025
Hospital Sanitas CIMA
Barcelona, 08034
Hospital Universitario Virgen de la Arrixaca
El Palmar, 30120
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Ramón y Cajal
Madrid, 28034
Hospital La Paz
Madrid, 28046
Hospital Puerta de Hierro
Majadahonda, 28222
Hospital Virgen de la Victoria
Málaga, 29010
Hospital Clínico de Santiago
Santiago de Compostela, 15706
Hospital Virgen Macarena
Seville, 41009
Hospital General Universitario de Valencia
Valencia, 46014
Hospital Arnau de Vilanova
Valencia, 46015
Belgium9 sites
C.H.U. de Charleroi
Charleroi, 6000
AZ Sint-Blasius
Dendermonde, 9200
Ziekenhuis Oost-Limburg - Campus Sint-Jan
Genk, 3600
AZ Maria Middelares
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
Liège - HOSP CHR de la Citadelle
Liège, 4000
United Kingdom8 sites
Barnet General Hospital
Barnet, EN5 3DJ
University Hospital of Wales
Cardiff, CF14 4XU
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
St Mary's Hospital
Newport, PO30 5TG
Morriston Hospital
Swansea, SA6 6NL
Singapore4 sites
National University Hospital
Singapore, 119074
National Heart Center
Singapore, 169609
Tan Tock Seng Hospital
Singapore, 308433
Khoo Teck Puat Hospital
Singapore, 768828
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 Preserved Ejection Fraction (HFpEF)
This is a study in adults with chronic heart failure. People with chronic heart failure may need to be hospitalised for their condition. Some people with chronic heart failure may eventually die from their condition. The purpose of the study is to find out whether a medicine called empagliflozin lowers the chances of patients having to go to hospital for heart failure and whether it improves their survival. The study is open to patients with a type of chronic heart failure called chronic heart failure with preserved ejection fraction.
Participants stay in the study until researchers have enough information about how effective empagliflozin is. It is expected that participants who enter at the very beginning of the enrolment period may be in the study for over 3 years, while participants who enter near the end of the enrolment period may be in the study for less than 2 years. The participants are put into 2 groups. It is decided by chance who gets into which group. One group gets empagliflozin tablets every day and the other group gets placebo tablets every day. Placebo tablets look like empagliflozin tablets but contain no medicine.
Participants visit the doctors regularly. During these visits, the doctors collect information about the participant's health. The doctors want to know how many patients had to go to hospital because of heart failure or who died from cardiovascular disease.
- 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 group | Role | What they receive |
|---|---|---|
| 10 mg Empagliflozin | Experimental | Not described Receives: Drug: Empagliflozin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)
Failure with preserved Ejection Fraction (HFpEF). The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:
Incidence rate per 100 pt-yrs = 100 * number of patients with event / time at risk [years].
Time at risk [years] = 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.
Measured: From randomization until completion of the planned treatment phase, up to 1403 days.
Secondary outcomes (9)
Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent)
Reported is the total number of adjudicated HHF events (first and recurrent) which occurred.
Measured: From randomization until completion of the planned treatment phase, up to 1403 days.
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) slope of change from baseline.
Available on-treatment change-from-baseline data were used. The slope represents the long term effect of eGFR change from baseline and provides the yearly rate of decline.
Timepoints after baseline were included in calculation of slope of change from baseline.
The slope per patient was calculated using a random coefficient model with terms for treatment, region, baseline status of diabetes, age, sex, left ventricular ejection fraction (LVEF) and glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)cr) at baseline and in addition the factors "time", "treatment-by-time interaction", and "baseline eGFR (CKD-EPI)cr-by-time interaction".
Measured: At baseline, week 4, 12, 32, 52, 76, 100, 124, 148, 172 and week 196, up to 1043 days.
Time to the First Event in the Composite Renal Endpoint: Chronic Dialysis, Renal Transplant, or Sustained Reduction in eGFR (CKD-EPI)cr
Chronic dialysis was defined as dialysis with a frequency of twice per week or more for at least 90 days.
Sustained was determined by two or more consecutive post-baseline central laboratory measurement separated by at least 30 days.
Reduction in glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) was defined as reduction in eGFR from baseline ≥40%, eGFR <15 mL/min/1.73 m^2 for patients with baseline eGFR ≥30 mL/min/1.73 m^2, or eGFR <10 mL/min/1.73 m^2 for patients with baseline eGFR <30 mL/min/1.73 m^2.
The incidence rate per 100 patient years (100 * number of patients with event / time at risk [years]) is reported. Time at risk [year] is calculated as: Sum of time at risk [days] over all patients in a treatment group / 365.25.
Abbreviation:
Patient-years (pt-yrs).
Measured: From randomization until completion of the planned treatment phase, up to 1403 days.
Time to First Adjudicated Hospitalisation for Heart Failure (HHF)
Time to first adjudicated HHF. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:
Incidence rate per 100 pt-yrs = 100 * number of patients with event / time at risk [years].
Time at risk [years] = 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.
Measured: From randomization until completion of the planned treatment phase, up to 1403 days.
Time to Adjudicated Cardiovascular (CV) Death
Time to adjudicated CV death. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:
Incidence rate per 100 pt-yrs = 100 * number of patients with event / time at risk [years].
Time at risk [years] = 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.
Measured: From randomization until completion of the planned treatment phase, up to 1403 days.
Time to All-cause Mortality
Time to all-cause mortality. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:
Incidence rate per 100 pt-yrs = 100 * number of patients with event / time at risk [years].
Time at risk [years] = 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.
Measured: From randomization until completion of the planned treatment phase, up to 1403 days.
Time to Onset of Diabetes Mellitus (DM) in Patients With Pre-DM
Time to onset of DM (defined as HbA1c ≥6.5% or as diagnosed by the investigator) in patients with pre-DM.
Pre-DM was defined as no history of DM and no HbA1c ≥6.5% before treatment, and a pre-treatment HbA1c value of ≥5.7% and <6.5%.
The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:
Incidence rate per 100 pt-yrs = 100 * number of patients with event / time at risk [years].
Time at risk [years] = 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.
Measured: From randomization until completion of the planned treatment phase, to 1403 days.
Change From Baseline in Kansas City Cardiomyopathy Questionaire (KCCQ) 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, self-efficacy, 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) was imputed for the score at all subsequent scheduled visits after the date of death where the score would have been assessed.
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: At baseline and at week 12, week 32 and week 52.
Occurrence of All-cause Hospitalisation (First and Recurrent)
Occurrence of all-cause hospitalisation (first and recurrent). Total number of all cause hospitalisations is reported.
Measured: From randomization until completion of the planned treatment phase, up to 1403 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start2 Mar 2017
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 5,988 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057951
- Sponsor's protocol ID
- 1245.110
- Other IDs
- 2016-002278-11, 2016
- Status last verified
- Jun 2022
- First submitted
- 16 Feb 2017
- Last updated
- 6 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ferreira JP, Packer M, Butler J, Vasques-Novoa F, Marques P, Pocock S, Filippatos G, Zannad F, Anker SD. Serum Magnesium, Outcomes, and the Effect of Empagliflozin in Heart Failure With Mildly Reduced and Preserved Ejection Fraction: Findings From EMPEROR-Preserved. JACC Heart Fail. 2026 Feb;14(2):102889. doi: 10.1016/j.jchf.2025.102889. Epub 2026 Jan 5.
PubMed 41493412Carson P, Teerlink JR, Komajda M, Anand I, Packer M, Butler J, Doehner W, Ferreira JP, Filippatos G, Haass M, Miller A, Pehrson S, Pocock SJ, Iwata T, Brueckmann M, Gasior T, Zannad F, Anker SD. Comparison of Investigator-Reported and Centrally Adjudicated Heart Failure Outcomes in the EMPEROR-Preserved Trial. JACC Heart Fail. 2025 May;13(5):710-721. doi: 10.1016/j.jchf.2024.10.021. Epub 2025 Jan 29.
PubMed 39895437Natale 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 38770818Talha KM, Green J, Filippatos G, Pocock S, Zannad F, Brueckmann M, Schueler E, Ofstad AP, Ferreira JP, Anker SD, Butler J, Rosenstock J, Packer M. Impact of empagliflozin on insulin needs in patients with heart failure and diabetes: An EMPEROR-Pooled analysis. Diabetes Obes Metab. 2024 Jul;26(7):2578-2587. doi: 10.1111/dom.15572. Epub 2024 Apr 1.
PubMed 38558314Ferreira JP, Packer M, Sattar N, Butler J, Pocock SJ, Anker SD, Maldonado SG, Panova-Noeva M, Sumin M, Masson S, Zannad F, Januzzi JL. Carbohydrate antigen 125 concentrations across the ejection fraction spectrum in chronic heart failure: The EMPEROR programme. Eur J Heart Fail. 2024 Apr;26(4):788-802. doi: 10.1002/ejhf.3166. Epub 2024 Mar 4.
PubMed 38439582Coats AJS, Butler J, Tsutsui H, Doehner W, Filippatos G, Ferreira JP, Bohm M, Chopra VK, Verma S, Nordaby M, Iwata T, Nitta D, Ponikowski P, Zannad F, Packer M, Anker SD. Efficacy of empagliflozin in heart failure with preserved ejection fraction according to frailty status in EMPEROR-Preserved. J Cachexia Sarcopenia Muscle. 2024 Feb;15(1):412-424. doi: 10.1002/jcsm.13393. Epub 2023 Dec 29.
PubMed 38158636Ferreira JP, Butler J, Anker SD, Januzzi JL, Panova-Noeva M, Reese-Petersen AL, Sattar N, Schueler E, Pocock SJ, Filippatos G, Packer M, Sumin M, Zannad F; EMPEROR Committees and Investigators. Effects of empagliflozin on collagen biomarkers in patients with heart failure: Findings from the EMPEROR trials. Eur J Heart Fail. 2024 Feb;26(2):274-284. doi: 10.1002/ejhf.3101. Epub 2023 Dec 28.
PubMed 38037709Zannad F, Macari S. Drug treatment with empagliflozin was beneficial in people with heart failure with preserved ejection fraction: plain language summary of the EMPEROR-Preserved study. Future Cardiol. 2023 Nov;19(14):671-677. doi: 10.2217/fca-2023-0091. Epub 2023 Nov 9.
PubMed 37942723Packer M, Butler J, Zeller C, Pocock SJ, Brueckmann M, Ferreira JP, Filippatos G, Usman MS, Zannad F, Anker SD. Blinded Withdrawal of Long-Term Randomized Treatment With Empagliflozin or Placebo in Patients With Heart Failure. Circulation. 2023 Sep 26;148(13):1011-1022. doi: 10.1161/CIRCULATIONAHA.123.065748. Epub 2023 Aug 24.
PubMed 37621153Butler J, Usman MS, Filippatos G, Ferreira JP, Bohm M, Brueckmann M, Januzzi JL, Kaul S, Pina IL, Ponikowski P, Senni M, Sumin M, Verma S, Zaremba-Pechmann L, Pocock SJ, Packer M, Anker S. Safety and Efficacy of Empagliflozin and Diuretic Use in Patients with Heart Failure and Preserved Ejection Fraction: A Post Hoc Analysis of the EMPEROR-Preserved Trial. JAMA Cardiol. 2023 Jul 1;8(7):640-649. doi: 10.1001/jamacardio.2023.1090.
PubMed 37223933Bhm M, Anker S, Mahfoud F, Lauder L, Filippatos G, Ferreira JP, Pocock SJ, Brueckmann M, Saloustros I, Schler E, Wanner C, Zannad F, Packer M, Butler J. Empagliflozin, irrespective of blood pressure, improves outcomes in heart failure with preserved ejection fraction: the EMPEROR-Preserved trial. Eur Heart J. 2023 Feb 1;44(5):396-407. doi: 10.1093/eurheartj/ehac693.
PubMed 36478225Ferreira JP, Zannad F, Butler J, Filippatos G, Pocock SJ, Brueckmann M, Steubl D, Schueler E, Anker SD, Packer M. Association of Empagliflozin Treatment With Albuminuria Levels in Patients With Heart Failure: A Secondary Analysis of EMPEROR-Pooled. JAMA Cardiol. 2022 Nov 1;7(11):1148-1159. doi: 10.1001/jamacardio.2022.2924.
PubMed 36129693Butler J, Filippatos G, Siddiqi TJ, Ferreira JP, Brueckmann M, Bocchi E, Bohm M, Chopra VK, Giannetti N, Iwata T, Januzzi JL, Kaul S, Pina IL, Ponikowski P, Rauch-Krohnert U, Shah SJ, Senni M, Sumin M, Verma S, Zhang J, Pocock SJ, Zannad F, Packer M, Anker SD. Effects of Empagliflozin in Women and Men With Heart Failure and Preserved Ejection Fraction. Circulation. 2022 Oct 4;146(14):1046-1055. doi: 10.1161/CIRCULATIONAHA.122.059755. Epub 2022 Sep 13.
PubMed 36098051Zannad F, Ferreira JP, Butler J, Filippatos G, Januzzi JL, Sumin M, Zwick M, Saadati M, Pocock SJ, Sattar N, Anker SD, Packer M. Effect of empagliflozin on circulating proteomics in heart failure: mechanistic insights into the EMPEROR programme. Eur Heart J. 2022 Dec 21;43(48):4991-5002. doi: 10.1093/eurheartj/ehac495.
PubMed 36017745Filippatos G, Butler J, Farmakis D, Zannad F, Ofstad AP, Ferreira JP, Green JB, Rosenstock J, Schnaidt S, Brueckmann M, Pocock SJ, Packer M, Anker SD; EMPEROR-Preserved Trial Committees and Investigators. Empagliflozin for Heart Failure With Preserved Left Ventricular Ejection Fraction With and Without Diabetes. Circulation. 2022 Aug 30;146(9):676-686. doi: 10.1161/CIRCULATIONAHA.122.059785. Epub 2022 Jun 28.
PubMed 35762322
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Preserved Ejection Fraction (HFpEF)
- ClinicalTrials.gov ID
- NCT03057951
- Acronym / sponsor ID
- 1245.110
- Conditions
- Heart Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,988 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 20 Feb 2017 (actual)
- Results
- Posted 6 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study in adults with chronic heart failure. People with chronic heart failure may need to be hospitalised for their condition. Some people with chronic heart failure may eventually die from their condition. The purpose of the study is to find out whether a medicine called empagliflozin lowers the chances of patients having to go to hospital for heart failure and whether it improves their survival. The study is open to patients with a type of chronic heart failure called chronic heart failure with preserved ejection fraction.
Participants stay in the study until researchers have enough information about how effective empagliflozin is. It is expected that participants who enter at the very beginning of the enrolment period may be in the study for over 3 years, while participants who enter near the end of the enrolment period may be in the study for less than 2 years. The participants are put into 2 groups. It is decided by chance who gets into which group. One group gets empagliflozin tablets every day and the other group gets placebo tablets every day. Placebo tablets look like empagliflozin tablets but contain no medicine.
Participants visit the doctors regularly. During these visits, the doctors collect information about the participant's health. The doctors want to know how many patients had to go to hospital because of heart failure or who died from cardiovascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 mg Empagliflozin | Experimental | Drug: Empagliflozin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
- Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1
- Stable dose of oral diuretics, if prescribed
- Signed and dated written ICF (informed consent form)
Key exclusion criteria (13 listed)
- 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 (Heart Failure)
- Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
- Symptomatic hypotension and/or a SBP < 100 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinAlso: JARDIANCE, JARDIANZ, GIBTULIOonce daily | Drug | 10 mg Empagliflozin |
| Placeboonce daily | Drug | Placebo |
Primary outcome
Time to First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)
Time frame: From randomization until completion of the planned treatment phase, up to 1403 days.
Failure with preserved Ejection Fraction (HFpEF). The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed: Incidence rate per 100 pt-yrs = 100 * number of patients with event / time at risk [years]. Time at risk [years] = 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.
9 secondary outcomes
Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent)
Time frame: From randomization until completion of the planned treatment phase, up to 1403 days.
eGFR (CKD-EPI) cr Slope of Change From Baseline
Time frame: At baseline, week 4, 12, 32, 52, 76, 100, 124, 148, 172 and week 196, up to 1043 days.
Time to the First Event in the Composite Renal Endpoint: Chronic Dialysis, Renal Transplant, or Sustained Reduction in eGFR (CKD-EPI)cr
Time frame: From randomization until completion of the planned treatment phase, up to 1403 days.
Time to First Adjudicated Hospitalisation for Heart Failure (HHF)
Time frame: From randomization until completion of the planned treatment phase, up to 1403 days.
Time to Adjudicated Cardiovascular (CV) Death
Time frame: From randomization until completion of the planned treatment phase, up to 1403 days.
Time to All-cause Mortality
Time frame: From randomization until completion of the planned treatment phase, up to 1403 days.
Time to Onset of Diabetes Mellitus (DM) in Patients With Pre-DM
Time frame: From randomization until completion of the planned treatment phase, to 1403 days.
Change From Baseline in Kansas City Cardiomyopathy Questionaire (KCCQ) Clinical Summary Score at Week 52
Time frame: At baseline and at week 12, week 32 and week 52.
Occurrence of All-cause Hospitalisation (First and Recurrent)
Time frame: From randomization until completion of the planned treatment phase, up to 1403 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41493412Ferreira JP, Packer M, Butler J, Vasques-Novoa F, Marques P, Pocock S, Filippatos G, Zannad F, Anker SD. Serum Magnesium, Outcomes, and the Effect of Empagliflozin in Heart Failure With Mildly Reduced and Preserved Ejection Fraction: Findings From EMPEROR-Preserved. JACC Heart Fail. 2026 Feb;14(2):102889. doi: 10.1016/j.jchf.2025.102889. Epub 2026 Jan 5.
- Derived from this study: PubMed 39895437Carson P, Teerlink JR, Komajda M, Anand I, Packer M, Butler J, Doehner W, Ferreira JP, Filippatos G, Haass M, Miller A, Pehrson S, Pocock SJ, Iwata T, Brueckmann M, Gasior T, Zannad F, Anker SD. Comparison of Investigator-Reported and Centrally Adjudicated Heart Failure Outcomes in the EMPEROR-Preserved Trial. JACC Heart Fail. 2025 May;13(5):710-721. doi: 10.1016/j.jchf.2024.10.021. Epub 2025 Jan 29.
- Derived from this study: PubMed 38770818Natale 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.
- Derived from this study: PubMed 38558314Talha KM, Green J, Filippatos G, Pocock S, Zannad F, Brueckmann M, Schueler E, Ofstad AP, Ferreira JP, Anker SD, Butler J, Rosenstock J, Packer M. Impact of empagliflozin on insulin needs in patients with heart failure and diabetes: An EMPEROR-Pooled analysis. Diabetes Obes Metab. 2024 Jul;26(7):2578-2587. doi: 10.1111/dom.15572. Epub 2024 Apr 1.
- Derived from this study: PubMed 38439582Ferreira JP, Packer M, Sattar N, Butler J, Pocock SJ, Anker SD, Maldonado SG, Panova-Noeva M, Sumin M, Masson S, Zannad F, Januzzi JL. Carbohydrate antigen 125 concentrations across the ejection fraction spectrum in chronic heart failure: The EMPEROR programme. Eur J Heart Fail. 2024 Apr;26(4):788-802. doi: 10.1002/ejhf.3166. Epub 2024 Mar 4.
- Derived from this study: PubMed 38158636Coats AJS, Butler J, Tsutsui H, Doehner W, Filippatos G, Ferreira JP, Bohm M, Chopra VK, Verma S, Nordaby M, Iwata T, Nitta D, Ponikowski P, Zannad F, Packer M, Anker SD. Efficacy of empagliflozin in heart failure with preserved ejection fraction according to frailty status in EMPEROR-Preserved. J Cachexia Sarcopenia Muscle. 2024 Feb;15(1):412-424. doi: 10.1002/jcsm.13393. Epub 2023 Dec 29.
- Derived from this study: PubMed 38037709Ferreira JP, Butler J, Anker SD, Januzzi JL, Panova-Noeva M, Reese-Petersen AL, Sattar N, Schueler E, Pocock SJ, Filippatos G, Packer M, Sumin M, Zannad F; EMPEROR Committees and Investigators. Effects of empagliflozin on collagen biomarkers in patients with heart failure: Findings from the EMPEROR trials. Eur J Heart Fail. 2024 Feb;26(2):274-284. doi: 10.1002/ejhf.3101. Epub 2023 Dec 28.
- Derived from this study: PubMed 37942723Zannad F, Macari S. Drug treatment with empagliflozin was beneficial in people with heart failure with preserved ejection fraction: plain language summary of the EMPEROR-Preserved study. Future Cardiol. 2023 Nov;19(14):671-677. doi: 10.2217/fca-2023-0091. Epub 2023 Nov 9.
- Derived from this study: PubMed 37621153Packer M, Butler J, Zeller C, Pocock SJ, Brueckmann M, Ferreira JP, Filippatos G, Usman MS, Zannad F, Anker SD. Blinded Withdrawal of Long-Term Randomized Treatment With Empagliflozin or Placebo in Patients With Heart Failure. Circulation. 2023 Sep 26;148(13):1011-1022. doi: 10.1161/CIRCULATIONAHA.123.065748. Epub 2023 Aug 24.
- Derived from this study: PubMed 37223933Butler J, Usman MS, Filippatos G, Ferreira JP, Bohm M, Brueckmann M, Januzzi JL, Kaul S, Pina IL, Ponikowski P, Senni M, Sumin M, Verma S, Zaremba-Pechmann L, Pocock SJ, Packer M, Anker S. Safety and Efficacy of Empagliflozin and Diuretic Use in Patients with Heart Failure and Preserved Ejection Fraction: A Post Hoc Analysis of the EMPEROR-Preserved Trial. JAMA Cardiol. 2023 Jul 1;8(7):640-649. doi: 10.1001/jamacardio.2023.1090.
- Derived from this study: PubMed 36478225Bhm M, Anker S, Mahfoud F, Lauder L, Filippatos G, Ferreira JP, Pocock SJ, Brueckmann M, Saloustros I, Schler E, Wanner C, Zannad F, Packer M, Butler J. Empagliflozin, irrespective of blood pressure, improves outcomes in heart failure with preserved ejection fraction: the EMPEROR-Preserved trial. Eur Heart J. 2023 Feb 1;44(5):396-407. doi: 10.1093/eurheartj/ehac693.
- Derived from this study: PubMed 36129693Ferreira JP, Zannad F, Butler J, Filippatos G, Pocock SJ, Brueckmann M, Steubl D, Schueler E, Anker SD, Packer M. Association of Empagliflozin Treatment With Albuminuria Levels in Patients With Heart Failure: A Secondary Analysis of EMPEROR-Pooled. JAMA Cardiol. 2022 Nov 1;7(11):1148-1159. doi: 10.1001/jamacardio.2022.2924.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
619 sites in 23 countries: see every site and its status.
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 619 sites in 23 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 6 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 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 619 sites in United States, Japan, Argentina, Brazil, Germany and 18 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 6 Jun 2022). 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 First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) (time frame: From randomization until completion of the planned treatment phase, up to 1403 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 NCT03057951, which also lists 23 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 6 Jun 2022.