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

June 3, 2022 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Completed

Conditions

Heart Failure

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5988

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Bahia Blanca, Argentina, B8001DDU
    - Hospital Interzonal General de Agudos Dr Jose Penna
  - Bahia Blanca, Argentina, B8001HXM
    - Hospital Italiano Regional del Sur, Bahia Blanca
  - Caba, Argentina, C1199ABB
    - Hospital Italiano de Buenos Aires
  - Caba, Argentina, C1119ACN
    - CIPREC
  - Ciudad Autonoma Buenos Aires, Argentina, C1428ART
    - Instituto Cardiovascular de Buenos Aires
  - Ciudad Autonoma Buenos Aires, Argentina, C1430CKE
    - Glenny Corp. S.A. Bioclinica Argentina
  - Ciudad Autonoma de Bs As, Argentina, C1120AAC
    - Centro Médico Viamonte
  - Ciudad Autonoma de BuenosAires, Argentina, C1425AGC
    - Consultorios Asociados de Endocrinología e Invest Clínica
  - Ciudad Autónoma de Bs As, Argentina, C1180AAX
    - Sanatorio Güemes
  - Ciudadela, Argentina, 1702
    - Instituto Medico Elsa Perez SRL (IMEP)
  - Cordoba, Argentina, X5003DCE
    - Instituto Médico DAMIC S.R.L.
  - Cordoba, Argentina, X5002AOQ
    - Clinica Privada Colombo- Fundacion Clinica Colombo
  - Coronel Suarez, Argentina, B7540GHD
    - Clinica Coronel Suarez SA
  - Corrientes, Argentina, W3400AMZ
    - Instituto de Cardiologia de Corrientes
  - Córdoba, Argentina, 5000
    - Sanatorio Mayo Privado SA
  - Córdoba, Argentina, X5000EVQ
    - Centro de Investigaciones Clinicas Instituto del Corazon
  - Córdoba, Argentina, X5000JHQ
    - Sanatorio Allende S.A.
  - Córdoba, Argentina, X5016KEH
    - Hospital Privado
  - La Plata, Argentina, B1900AXI
    - Hospital Italiano de la Plata
  - Mar del Plata, Argentina, B7602CBM
    - Hospital Privado de Comunidad
  - Mar del Plata, Argentina, B7600FYK
    - Centro de Investigaciones Médicas
  - Quilmes, Argentina, B1878DVB
    - CER Instituto Medico
  - Quilmes, Argentina, B1878GEG
    - Instituto de Investigaciones Clinicas de Quilmes
  - Rosario, Argentina, 2000
    - Instituto de Investigaciones Clinicas de Rosario
  - Rosario, Argentina, 2000
    - Instituto Medico Fundación Grupo Colaborativo Rosario
  - Rosario, Argentina, 2000
    - Sanatorio Britanico
  - Rosario, Argentina, 2000
    - Sanatorio Plaza
  - Rosario, Argentina, S2000PBJ
    - Instituto CAICI
  - Salta, Argentina, A4400ANW
    - CORDIS S.A., Salta
  - Salta, Argentina, A4406BFP
    - Centro Cardiovascular Salta
  - San Martin, Argentina, B1650CSQ
    - Corporacion Medica de Gral. San Martin S.A.
  - San Miguel de Tucuman, Argentina, T4000JCU
    - Instituto de Cardiología
  - San Miguel de Tucuman, Argentina, T4000
    - Clínica Mayo
  - San Miguel de Tucumán, Argentina, T4000ICL
    - Investigaciones Clinicas Tucuman
  - San Vicente, Argentina, X5006CBI
    - Centro Medico Luquez
  - Santa Fe, Argentina, S3000FWO
    - Centro de Investigaciones Clinicas del Litoral
  - Santa Fé, Argentina, S3000EOZ
    - Hospital "Dr. José Maria Cullen"
  - Vicente Lopez, Argentina, 1602
    - Clinica Olivos
  - Villa Luro, Argentina, C1440CFD
    - CEMEDIC - Centro de Especialidades Medicas
Australia
- New South Wales
  - Kotara, New South Wales, Australia, 2289
    - Pendlebury Research
  - New Lambton Heights, New South Wales, Australia, 2305
    - John Hunter Hospital
- Queensland
  - Milton, Queensland, Australia, 4064
    - Core Research Group
  - Southport, Queensland, Australia, 4215
    - Gold Coast University Hospital
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Royal Adelaide Hospital
  - Ashford, South Australia, Australia, 5035
    - Adelaide Medical Research
  - Bedford Park, South Australia, Australia, 5042
    - Flinders Medical Centre
  - Fullarton, South Australia, Australia, 5063
    - Heart and Vascular Research
  - Woodville South, South Australia, Australia, 5011
    - The Queen Elizabeth Hospital
- Victoria
  - Epping, Victoria, Australia, 3076
    - The Northern Hospital
  - Frankston, Victoria, Australia, 3199
    - Peninsula Private Hospital
  - Geelong, Victoria, Australia, 3220
    - University Hospital Geelong
- Western Australia
  - Perth, Western Australia, Australia, 6000
    - Mount Hospital
Belgium
- - Charleroi, Belgium, 6000
    - C.H.U. de Charleroi
  - Dendermonde, Belgium, 9200
    - AZ Sint-Blasius
  - Genk, Belgium, 3600
    - Ziekenhuis Oost-Limburg - Campus Sint-Jan
  - Gent, Belgium, 9000
    - AZ Maria Middelares
  - Gilly, Belgium, 6060
    - Grand Hopital de Charleroi
  - Hasselt, Belgium, 3500
    - Jessa Ziekenhuis - Campus Virga Jesse
  - La Louvière, Belgium, 7100
    - La Louvière - UNIV CHU Tivoli
  - Leuven, Belgium, 3000
    - UZ Leuven
  - Liège, Belgium, 4000
    - Liège - HOSP CHR de la Citadelle
Brazil
- - Bela Vista, Brazil, 01323-000
    - FGM - Clínica Paulista de Doenças Cardiovasculares
  - Belo Horizonte, Brazil, 30110-060
    - Hospital Felício Rocho
  - Belo Horizonte, Brazil, 30140-092
    - Hospital Vera Cruz
  - Brasília, Brazil, 70200-730
    - L2IP -Instituto de Pesquisas Clínicas Ltda.
  - Brasília, Brazil, 70673-900
    - ICDF - Instituto de Cardiologia do Distrito Federal
  - Brasília, Brazil, 70710-100
    - CECAP - Centro de Cardiologia Clínica
  - Campina Grande do Sul, Brazil, 83430-000
    - Irmandade da Santa Casa de Misericordia de Curitiba
  - Campinas, Brazil, 13010-001
    - Centro Especializado em Cardiol Loema Instituto de Pesq Clin
  - Campinas, Brazil, 13060-080
    - IPECC - Instituto de Pesquisa Clínica de Campinas
  - Campinas, Brazil, 13087-567
    - CAEP - Centro Avançado de Estudos e Pesquisas Ltda.,Campinas
  - Canoas, Brazil, 92425-900
    - Hospital Universitario
  - Caxias do Sul, Brazil, 95070-560
    - IPCEM - Instituto de Pesquisa Clínica para Estudos Multicêntricos - Universidade de Caxias do Sul
  - Curitiba, Brazil, 80230-130
    - Irmandade da Santa Casa de Misericordia de Curitiba
  - Goiânia, Brazil, 74223-130
    - Via Médica
  - Goiânia, Brazil, 74605-020
    - HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
  - Marília, Brazil, 17515-000
    - ICM - Instituto do Coração de Marília
  - Passo Fundo, Brazil, 99010-080
    - Hospital Sao Vicente de Paulo
  - Porto Alegre, Brazil, 90035-903
    - Hospital de Clinicas de Porto Alegre
  - Porto Alegre, Brazil, 90035-074
    - Santa Casa de Misericordia de Porto Alegre
  - Porto Alegre, Brazil, 90035-170
    - Centro de Pesquisas em Diabetes
  - Porto Alegre, Brazil, 90620-001
    - Instituto de Cardiologia Rio Grande do Sul
  - Recife, Brazil, 52051-380
    - Hospital Agamenon Magalhaes
  - Ribeirao Preto, Brazil, 14048-900
    - H.C.da Fac. de Medicina de Ribeirao Preto
  - Rio de Janeiro, Brazil, 20551-030
    - Hospital Universitário Pedro Ernesto UERJ
  - Rio de Janeiro, Brazil, 22271-100
    - CCBR - Rio de Janeiro - BR
  - Santa Efigenia, Brazil, 30150-240
    - Cardresearch Cardiologia Assistencial e de Pesquisas Ltda
  - Santo André, Brazil, 09090-790
    - Praxis Pesquisa Medica
  - Santo André, Brazil, 09080-110
    - Pesquisare
  - Sao Jose do Rio Preto, Brazil, 15090-000
    - Hospital de Base - Fac Med de Sao Jose do Rio Preto
  - Sao Paulo, Brazil, 01228-200
    - Centro de Pesquisa Clinica - CPCLIN
  - Sao Paulo, Brazil, 04266-010
    - CEPIC - Centro Paulista de Investigacao Clinica
  - Sao Paulo, Brazil, 05403-000
    - INCOR e Hospital das Clínicas da Universidade de São Paulo
  - São Bernardo do Campo, Brazil, 09780-000
    - CEMEC - Centro Multidisciplinar de Estudos Clínicos
  - São Paulo, Brazil, 04020-060
    - CDEC BRASIL - Centro de Desenvolvimento em Estudos Clínicos Brasil
  - São Paulo, Brazil, 05016-090
    - Dr. Consulta
  - Vitória, Brazil, 29055-450
    - CEDOES - Diagnóstico e Pesquisa,Vitória
  - Votuporanga, Brazil, 15500-003
    - Santa Casa de Votuporanga
Canada
- - Quebec, Canada, G1V 4G5
    - IUCPQ (Laval University)
- Alberta
  - Edmonton, Alberta, Canada, T5H 3V9
    - Royal Alexandra Hospital
- British Columbia
  - North Vancouver, British Columbia, Canada, V7M 2H4
    - Medical Arts Health Research Group
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - Vancouver General Hospital
  - Victoria, British Columbia, Canada, V8R 1B2
    - Victoria Heart Institute Foundation
- Manitoba
  - Winnipeg, Manitoba, Canada, R2H 2A6
    - St. Boniface General Hospital
- New Brunswick
  - Moncton, New Brunswick, Canada, E1G 1A7
    - G.A. Research Associates Ltd
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 3A7
    - QEII Health Sciences Centre
- Ontario
  - Brampton, Ontario, Canada, L6Z 4N5
    - Brampton Research Associates
  - Brampton, Ontario, Canada, L6W 2X7
    - Brampton Cardio Pulmonary Clinic
  - Burlington, Ontario, Canada, L7M 4Y1
    - JBN Medical Diagnostic Services Inc.
  - Cambridge, Ontario, Canada, N1R 6V6
    - Cambridge Cardiac Care Inc.
  - Cambridge, Ontario, Canada, N1R 7R1
    - Dr. Saul Vizel
  - Hamilton, Ontario, Canada, L8L 2X2
    - Hamilton General Hospital
  - Hamilton, Ontario, Canada, L8L 0A9
    - Curnew Medicine Professional Corporation
  - London, Ontario, Canada, N6A 5A5
    - University Hospital (LHSC)
  - Newmarket, Ontario, Canada, L3Y 2P6
    - PACE (Partners in Advanced Cardiac Evaluation)
  - Oakville, Ontario, Canada, L6K 3W7
    - M Heffernan Medicine Professional Corp.
  - Peterborough, Ontario, Canada, K9J 0B2
    - Kawartha Cardiology Clinical Trials
  - Scarborough, Ontario, Canada, M1E 5E9
    - Scarborough Cardiology Research
  - Scarborough, Ontario, Canada, M1B 4Z8
    - Heart Health Institute
  - Sudbury, Ontario, Canada, P3E 3Y9
    - Cardiovascular Contract Research Organization LTD
  - Toronto, Ontario, Canada, M3J 0K2
    - Canadian Phase Onward Inc.
  - Toronto, Ontario, Canada, M6B 1N6
    - North York Diagnostic and Cardiac Centre
  - Waterloo, Ontario, Canada, N2T 0C1
    - Mohan Babapulle Medicine Professional Medicine
  - York, Ontario, Canada, M9N 1W4
    - Dr. Louis C.H. Yao
- Quebec
  - Brossard, Quebec, Canada, J4Z 2K9
    - ViaCar Recherche Clinique Inc
  - Greenfield Park, Quebec, Canada, J4V 2G8
    - ViaCar Recherche Clinique Inc
  - Longeuil, Quebec, Canada, J4M 2X1
    - Centre de Dépistage et Recherche Cardiovasculaire Rive-Sud
  - Montreal, Quebec, Canada, H1T 1C8
    - Montreal Heart Institute
  - Montreal, Quebec, Canada, H3G 1A4
    - Montreal General Hospital - McGill University Health Centre
  - Montreal, Quebec, Canada, H4A 3J1
    - McGill University Health Centre (MUHC)
  - Montreal, Quebec, Canada, H1T 3Y7
    - Clinique Sante Cardio MC
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 0W8
    - Royal University Hospital
China
- - Beijing, China, 100037
    - Cardiovascular Institute and Fu Wai Hospital
  - Beijing, China, 100050
    - Beijing Friendship Hospital
  - Changchun, China, 130021
    - First Hospital of Jilin University
  - Changsha, China, 410005
    - Hunan Provincial People's Hospital
  - Changsha, China, 410011
    - 2nd Xiangya Hospital of Central South University
  - Changsha, China, 410015
    - The Third Hospital of Changsha
  - Dongguan, China, 523059
    - Dongguan people's hospital
  - Fuzhou, China, 350005
    - The First Affiliated Hospital Of Fujian Medical University
  - Guangzhou, China, 510180
    - Guangzhou First Municipal People's Hospital
  - Guangzhou, China, 510080
    - The First Afiliated Hospital, Sun Yet-sen University
  - Haikou, China, 570311
    - Hainan Provincial People's Hospital
  - Haikou, China, 570208
    - Haikou People's Hospital
  - Lanzhou, China, 730000
    - The First Affiliated Hospital of Lanzhou University
  - Lanzhou, China, 730030
    - The Second Affiliated Hospital of Lanzhou Medical University
  - Luzhou, China, 646099
    - The Affiliated Hospital Of Southwest Medical University
  - Nanchang, China, 330008
    - Nanchang University Affiliated 3rd Hospital
  - Nanjing, China, 210029
    - First Hospital Affiliated with Nanjing Medical University
  - Shanghai, China, 200040
    - Huashan Hospital, Fudan University
  - Shenyang, China, 110016
    - General Hospital of Shenyang Military Region
  - Shenyang, China, 110072
    - Shengjing Hospital of China Medical University
  - Tianjin, China, 300121
    - Tianjin Union Medical Center Nankai University Affiliated Hospital
  - Wuhan, China, 430060
    - Renmin Hospital of Wuhan University
  - Wuhan, China, 430030
    - Tongji Hospital, Tongji University
  - Xi'an, China, 710061
    - First Affiliated Hospital of Xi'an Jiaotong University
  - Yanji, China, 133000
    - Yanbian University Hospital
  - Yueyang, China, 414000
    - the first people hospital of Yue Yang
  - Zhenjiang, China, 212013
    - Affiliated Hospital of Jiangsu University
Colombia
- - Barranquilla, Colombia, 080003
    - Corazón IPS S.A.S.
  - Barranquilla, Colombia, 080020
    - Centro de Reumatologia y Ortopedia SAS, Barranquilla
  - Barranquilla, Colombia, 080020
    - IPS Centro Cientifico Asistencia
  - Bogota, Colombia, 111611
    - Endocare Research Institute
  - Bogota D.C, Colombia, 111611
    - CardioColombia S.A.S.
  - Cali, Colombia, 760032
    - Fundacion Valle del Lili
  - Cali, Colombia, 760002
    - IPS Centro Medico Julián Coronel S.A.
  - Cali, Colombia, 760036
    - Centro de Investigaciones Clinicas S.A.S
  - Cartagena, Colombia, 130001
    - Centro de Diagnostico Cardilogico
  - Cartagena, Colombia, 130010
    - Centro cardiovascular Aristides
  - Floridablanca, Colombia, 681002
    - Fundacion Cardiovascular de Colombia
  - Manizales, Colombia, 170004
    - Asociacion IPS Medicos Internistas de Caldas
  - Medellin, Colombia, 050025
    - Promotora Medica Las Americas SA
Czechia
- - Bilovec, Czechia, 74301
    - Poliklinika Humanitas
  - Brno, Czechia, 63600
    - Vojenska nemocnice Brno
  - Brno, Czechia, 656 91
    - Fakultni nemocnice u sv. Anny v Brne
  - Brno, Czechia, 625 00
    - University Hospital Brno
  - Brno, Czechia, 603 00
    - Internal and Cardiology Practice, MUDr. Karel Kamenik, Brno
  - Brno, Czechia, 615 00
    - MUDr. Alexandra Ludkova
  - Brno, Czechia, 63900
    - Nemocnice Milosrdnych bratri
  - Brno, Czechia, 65691
    - Univ.Hosp U Svate Anny, I.Internal Clinic-Cardiology,Brno
  - Broumov, Czechia, 55001
    - EDUMED s.r.o
  - Chrudim, Czechia, 53702
    - MUDr. Jan Hubac, s.r.o. Kardiologicka ambulance
  - Frydek-Mistek, Czechia, 73818
    - Hospital Frydek Mistek
  - Havlickuv Brod, Czechia, 580 22
    - Nemocnice Havlickuv Brod p.o.
  - Hradec Kralove, Czechia, 50002
    - Gepamed s.r.o., Pulm. Outpat. Office, Hradec Kralove
  - Louny, Czechia, 440 01
    - KardioLouny s.r.o.
  - Marianske Lazne, Czechia, 353 01
    - InterKardioML s.r.o.
  - Olomouc, Czechia, 779 00
    - Zdenek Vomacka
  - Pardubice, Czechia, 53002
    - PV-Kardiologie s.r.o.
  - Prague, Czechia, 158 00
    - Corintez s.r.o.
  - Praha 2, Czechia, 128 00
    - Vseobecna fakultni nemocnice v Praze
  - Praha 4, Czechia, 140 21
    - Institute for Clinical and Experimental Medicine
  - Praha 4 - Krc, Czechia, 140 59
    - University Thomayer's Hospital
  - Praha 5, Czechia, 15006
    - University Hospital Motol
  - Prerov, Czechia, 75000
    - Kardio Vaclavik s.r.o.
  - Trebic, Czechia, 674 01
    - Nemocnice Trebic p.o.
  - Tremosna, Czechia, 33011
    - Kardiologicka ambulance
  - Trutnov, Czechia, 541 01
    - Kardiologicka ambulance MUDr. Ferkl s.r.o.
  - Uherske Hradiste, Czechia, 68601
    - Clinical Trials Services s.r.o
  - Unicov, Czechia, 783 91
    - Cardiology Private Practice
  - Zlin, Czechia, 76001
    - Angiocor s.r.o
  - Znojmo, Czechia, 66902
    - KIGE s.r.o
Germany
- - Aachen, Germany, 52074
    - Universitätsklinikum Aachen, AöR
  - Berlin, Germany, 12351
    - Vivantes Netzwerk für Gesundheit GmbH
  - Berlin, Germany, 13353
    - Charité - Universitätsmedizin Berlin
  - Berlin, Germany, 12203
    - Charité - Universitätsmedizin Berlin
  - Berlin, Germany, 10967
    - Vivantes Netzwerk für Gesundheit GmbH
  - Berlin, Germany, 10789
    - Praxis Dr. Rieker, Berlin
  - Bielefeld, Germany, 33604
    - Klinikum Bielefeld gGmbH
  - Bochum, Germany, 44791
    - Augusta-Kranken-Anstalt gGmbH
  - Dessau-Roßlau, Germany, 06846
    - Praxis Dr. Menzel
  - Dortmund, Germany, 44137
    - St. Johannes Hospital Dortmund
  - Dresden, Germany, 01307
    - Universitätsklinikum Carl Gustav Carus Dresden
  - Dresden, Germany, 01067
    - Städtisches Klinikum Dresden
  - Erfurt, Germany, 99089
    - Helios Klinikum Erfurt
  - Essen, Germany, 45355
    - Studienzentrum Bocholderstrasse
  - Frankfurt, Germany, 60596
    - ClinPhenomics GmbH & Co KG, Frankfurt
  - Göttingen, Germany, 37075
    - Universitätsmedizin Göttingen, Georg-August-Universität
  - Hannover, Germany, 30625
    - Medizinische Hochschule Hannover
  - Heidelberg, Germany, 69120
    - Universitätsklinikum Heidelberg
  - Homburg, Germany, 66421
    - Universitätsklinikum des Saarlandes
  - Jena, Germany, 07740
    - Universitätsklinikum Jena
  - Kiel, Germany, 24105
    - Universitätsklinikum Schleswig-Holstein, Campus Kiel
  - Langen, Germany, 63225
    - Asklepios Klinik Langen-Seligenstadt GmbH
  - Lüdenscheid, Germany, 58515
    - Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid
  - Lüneburg, Germany, 21339
    - Praxis Dr. Sarnighausen, Lüneburg
  - Mainz, Germany, 55131
    - Katholisches Klinikum Mainz
  - Mannheim, Germany, 68165
    - Gemeinschaftspraxis Drs. Kohler/Salbach, Mannheim
  - München, Germany, 80636
    - Deutsches Herzzentrum München
  - Nürnberg, Germany, 90402
    - Gemeinschaftspraxis Dres Haggenmiller/Jeserich
  - Papenburg, Germany, 26871
    - Kardiologische Praxis Papenburg
  - Regensburg, Germany, 93053
    - Universitätsklinikum Regensburg
  - Riesa, Germany, 01587
    - Praxis Dr. Stenzel, Riesa
  - Wangen im Allgäu, Germany, 88239
    - Zentrum für klinische Forschung
  - Warendorf, Germany, 48231
    - Josephs-Hospital Warendorf
  - Wermsdorf, Germany, 04779
    - Kardiologische Praxis, Wermsdorf
  - Wuppertal, Germany, 42283
    - Petrus-Krankenhaus
Hungary
- - Baja, Hungary, 6500
    - Lausmed Kft. Outpatient Unit of Internal Medicine
  - Bekescsaba, Hungary, 5600
    - Belgyogyaszati es Kardiologiai Maganrendelo
  - Budapest, Hungary, 1033
    - Clinexpert Kft.
  - Budapest, Hungary, 1122
    - Semmelweis University
  - Budapest, Hungary, 1023
    - Budai Irgalmasrendi Korhaz
  - Budapest, Hungary, 1106
    - Bajcsy-Zsilinszky Hospital and Clinic
  - Budapest, Hungary, 1134
    - Milit.Hosp.-State Health Cent.
  - Budapest, Hungary, 1145
    - Uzsoki Street Hospital, Budapest
  - Debrecen, Hungary, 4032
    - University Debrecen Hospital
  - Debrecen, Hungary, 4027
    - Nehezlegzes Ambulancia
  - Gyongyos, Hungary, 3200
    - Bugat Pal Hospital, Gyongyos
  - Kalocsa, Hungary, 6300
    - Studium Egeszseghaz Kft.
  - Komarom, Hungary, 2921
    - Selye Janos Hospital Komarom
  - Nagykanizsa, Hungary, 8800
    - Dorottya Kanizsai Hospital
  - Nyiregyhaza, Hungary, 4400
    - Medifarma-98 Kft.
  - Oroshaza, Hungary, 5900
    - Dr. Nagy Laszlo Kardiologiai Maganrendeles
  - Pecs, Hungary, 7624
    - University of Pecs
  - Pecs, Hungary, 7635
    - Da Vinci Private Clinic
  - Szekesfehervar, Hungary, 8000
    - Fejer County Saint George University Teaching Hospital
  - Veszprem, Hungary, 8200
    - Veszpremi Sziv es Egeszseg Centrum
India
- - Ahmedabad, India, 380007
    - Doctor Jivraj Mehta Smarak Health Foundation
  - Aurangabad, India, 431 005
    - Kamalnayan Bajaj Hospital
  - Bangalore, India, 560099
    - Narayana Institute of Cardiac Sciences
  - Bengaluru, India, 560074
    - Rajarajeswari Medical College
  - Chennai, India, 600 037
    - Madras Medical Mission,
  - Chennai, India, 600006
    - Apollo Speciality Hospital
  - Gurgaon, India, 122001
    - Medanta-The Medicity
  - Guwahati, India, 781006
    - GNRC Hospital
  - Kolkatta, India, 700027
    - B.M. Birla Heart research Centre
  - Nashik, India, 422007
    - Siddhi Hospital
  - Nasik, India, 422005
    - Vijan Cardiac and Critical Care Centre
  - New Delhi, India, 110060
    - Sir Gangaram Hospital
  - New Delhi, India, 110002
    - GB Pant Hospital
  - New Delhi, India, 110025
    - Fortis Escorts Heart Institute
  - New Delhi, India, 110062
    - Batra Hospital and Medical Research Centre
Italy
- - Benevento, Italy, 82100
    - Azienda Ospedaliera G. Rummo
  - Bergamo, Italy, 24127
    - ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII
  - Cona (FE), Italy, 44124
    - Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
  - Cortona, Italy, 52040
    - Ospedale della Val di Chiana Santa Margherita
  - Milano, Italy, 20122
    - Milano Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
  - Milano, Italy, 20138
    - Centro Cardiologico Monzino-IRCCS
  - Napoli, Italy, 80131
    - Azienda Ospedaliera Universitaria "Federico II"
  - Pisa, Italy, 56126
    - Azienda Ospedaliera Universitaria Pisana
  - Roma, Italy, 00189
    - Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
  - Roma, Italy, 00161
    - AOU Policlinico Umberto I
  - Rozzano (MI), Italy, 20089
    - Istituto Clinico Humanitas
  - Sesto San Giovanni (MI), Italy, 20099
    - IRCCS Gruppo Multimedica
  - Trieste, Italy, 34128
    - Azienda Servizi Sanitari 1 Triestina
Japan
- - Aichi, Kasugai, Japan, 486-8510
    - Kasugai Municipal Hospital
  - Aichi, Nagoya, Japan, 466-8650
    - Japanese Red Cross Nagoya Daini Hospital
  - Chiba, Chiba, Japan, 263-0043
    - Chiba Heart Clinic
  - Chiba, Kisarazu, Japan, 292-8535
    - Kimitsu Chuo Hospital
  - Chiba, Matsudo, Japan, 271-0077
    - Seikeikai New Tokyo Heart Clinic
  - Ehime, Matsuyama, Japan, 790-0024
    - Ehime Prefectural Central Hospital
  - Ehime, Matsuyama, Japan, 790-0067
    - Matsuyama Shimin Hospital
  - Ehime, Uwajima, Japan, 798-8510
    - Uwajima City Hospital
  - Fukui, Fukui, Japan, 918-8503
    - Fukuiken Saiseikai Hospital
  - Fukuoka, Chikushino, Japan, 818-8502
    - Fukuoka University Chikushi Hospital
  - Fukuoka, Chikushino, Japan, 818-8516
    - Fukuokaken Saiseikai Futsukaichi Hospital
  - Fukuoka, Fukuoka, Japan, 810-0001
    - Saiseikai Fukuoka General Hospital
  - Fukuoka, Fukuoka, Japan, 810-8563
    - National Hospital Organization Kyushu Medical Center
  - Fukuoka, Fukuoka, Japan, 812-8582
    - Kyushu University Hospital
  - Fukuoka, Kitakyushu, Japan, 806-8501
    - Japan Community Health care Organization Kyushu Hospital
  - Fukuoka, Kitakyushu, Japan, 805-8508
    - Steel Memorial Yawata Hospital
  - Fukushima, Shirakawa, Japan, 961-0005
    - Shirakawa Kosei General Hospital
  - Gifu, Ogaki, Japan, 503-8502
    - Ogaki Municipal Hospital
  - Gifu, Seki, Japan, 501-3802
    - Chuno Kosei Hospital
  - Hiroshima, Fukuyama, Japan, 721-8511
    - Fukuyama City Hospital
  - Hiroshima, Shobara, Japan, 727-0013
    - Shobara Red Cross Hospital
  - Hokkaido, Sapporo, Japan, 003-0026
    - Matsuda Cardiovascular clinic
  - Hokkaido, Sapporo, Japan, 006-0811
    - Teine Keijinkai Clinic
  - Hokkaido, Tomakomai, Japan, 053-8567
    - Tomakomai City Hospital
  - Hokkaido,Otaru, Japan, 047-8510
    - Otaru Kyokai Hospital
  - Hyogo, Amagasaki, Japan, 660-8550
    - Hyogo Prefectural Amagasaki General Medical Center
  - Hyogo, Himeji, Japan, 670-0981
    - Hyogo Brain and Heart Center
  - Hyogo, Kobe, Japan, 654-0155
    - National Hospital Organization Kobe Medical Center
  - Ibaraki, Higashiibaraki-gun, Japan, 311-3193
    - Mito Medical Center
  - Ibaraki, Koga, Japan, 306-0041
    - Tokushukai Koga General Hospital
  - Ishikawa, Kanazawa, Japan, 920-8650
    - National Hospital Organization Kanazawa Medical Center
  - Kagawa, Kanonji, Japan, 769-1695
    - Mitoyo General Hospital
  - Kagawa, Takamatsu, Japan, 760-8557
    - Kagawa Prefectural Central Hospital
  - Kanagawa, Kawasaki, Japan, 212-0021
    - Sekishinkai Second Kawasaki Saiwai Clinic
  - Kanagawa, Sagamihara, Japan, 252-0311
    - Yamamoto Clinic
  - Kanagawa, Yokohama, Japan, 236-0051
    - Kanagawa Cardiovascular and Respiratory Center
  - Kumamoto, Kumamoto, Japan, 861-8520
    - Japanese Red Cross Kumamoto Hospital
  - Kumamoto, Kumamoto, Japan, 862-0950
    - Seiwakai Suizenji Touya Hospital
  - Kumamoto, Yatsushiro, Japan, 866-8533
    - Kumamoto Rosai Hospital
  - Kusatsu, Japan, 525-8585
    - Omi Medical Center
  - Kyoto, Uji, Japan, 611-0041
    - Uji-Tokushukai Medical Center
  - Miyagi, Sendai, Japan, 983-8520
    - National Hospital Organization Sendai Medical Center
  - Miyagi, Sendai, Japan, 980-0873
    - Sendai Kousei Hospital
  - Miyagi, Sendai, Japan, 981-3131
    - Sendai Tokushukai Hospital
  - Miyazaki, Miyazaki, Japan, 880-2102
    - Miyazaki Medical Association Hospital
  - Nagano, Nakano, Japan, 383-8505
    - Hokushin General Hospital
  - Nagasaki, Omura, Japan, 856-8562
    - Nagasaki Medical Center
  - Oita, Oita, Japan, 870-0263
    - Oita Medical Center
  - Okayama, Okayama, Japan, 700-8557
    - Okayama City General Medical Center
  - Okinawa, Naha, Japan, 902-8511
    - Naha City Hospital
  - Okinawa, Shimajiri-gun, Japan, 901-0493
    - Nanbu Tokushukai Hospital
  - Okinawa, Urasoe, Japan, 901-2132
    - Urasoe General Hospital
  - Osaka, Higashiosaka, Japan, 578-8588
    - Higashiosaka City Medical Center
  - Osaka, Osaka, Japan, 530-8480
    - Kitano Hospital
  - Osaka, Osaka, Japan, 533-0024
    - Yodogawa Christian Hospital
  - Osaka, Takatsuki, Japan, 569-8585
    - Hokusetsu General Hospital
  - Saitama, Saitama, Japan, 338-0837
    - San-Ai Hospital
  - Saitama, Saitama, Japan, 339-0033
    - Kosekai Iwatsuki-minami Hospital
  - Tokushima, Tokushima, Japan, 770-8539
    - Tokushima Prefectural Central Hospital
  - Tokyo, Meguro-ku, Japan, 152-8902
    - National Hospital Organization Tokyo Medical Center
  - Tokyo, Ome, Japan, 198-0042
    - Ome Municipal General Hospital
  - Tokyo, Ota-ku, Japan, 143-0013
    - Tokyo Rosai Hospital
  - Tokyo, Toshima-ku, Japan, 171-0014
    - Sekino Hospital
  - Wakayama, Tanabe, Japan, 646-8558
    - Minami Wakayama Medical Center
  - Yamaguchi, Shimonoseki, Japan, 752-8510
    - Kanmon Medical Center
Korea, Republic of
- - Busan, Korea, Republic of, 49201
    - Dong-A University Hospital
  - Busan, Korea, Republic of, 47392
    - Inje University Busan Paik Hospital
  - Cheongju-si, Korea, Republic of, 28644
    - Chungbuk National University Hospital
  - Daejeon, Korea, Republic of, 35015
    - Chungnam National University Hospital
  - Gwangju, Korea, Republic of, 61469
    - Chonnam National University Hospital
  - Gyeonggi-Do, Korea, Republic of, 13620
    - Seoul National University Bundang Hospital
  - Incheon, Korea, Republic of, 21565
    - Gachon University Gil Medical Center
  - Seoul, Korea, Republic of, 03080
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 03722
    - Severance Hospital
  - Seoul, Korea, Republic of, 05505
    - Asan Medical Center
  - Seoul, Korea, Republic of, 08308
    - Korea University Guro Hospital
  - Seoul, Korea, Republic of, 06351
    - Samsung Medical Center
  - Wonju-si, Korea, Republic of, 26426
    - Wonju Severance Christian Hosp
Mexico
- - Aguascalientes, Mexico, 20230
    - Hospital Cardiologica Aguascalientes
  - Distrito Federal, Mexico, 03100
    - Centro de Investigacion Biomedica y Farmaceutica, S.C.
  - Guadalajara, Mexico, 44150
    - Unidad de Investigacion Clinica Cardiometabolica de Occident
  - Guadalajara, Mexico, 44100
    - Hospital Ramon Garibay
  - Guadalajara, Mexico, 44130
    - Diseño y Planeación en Investigación Médica SC
  - Guadalajara, Mexico, 44670
    - Cardiologia Clinica e Intervencionista
  - Mexico, Mexico, 07020
    - Centro de Investigación Clinica Acelerada, S.C.
  - Monclova, Mexico, 25750
    - Instituto Cardiovascular de Monclova, S de RL de CV
  - México, Mexico, C.P. 11650
    - CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc
  - Nuevo Leon, Mexico, 64460
    - Hospital Universitario Dr Jose Eleuterio Gonzalez
  - San Juan del Rio, Mexico, 76800
    - Centro Integral Medico SJR S.C.
  - San Luis Potosi, Mexico, 78213
    - Cardioarritmias e Investigación S.C
  - Tijuana, Mexico, 22500
    - Centro de Investigacion Cardiovascular y Metabólica
  - Torreon, Mexico, 27000
    - Centro de Investigacion Medica Alberto Bazzoni S.A. de C.V.
Netherlands
- - Almelo, Netherlands, 7609 PP
    - Ziekenhuisgroep Twente locatie Almelo
  - Amsterdam, Netherlands, 1105 AZ
    - Amsterdam UMC, Locatie AMC
  - Amsterdam, Netherlands, 1034 CS
    - BovenIJ Ziekenhuis
  - Amsterdam, Netherlands, 1081HV
    - Amsterdam UMC locatie VUMC
  - Amsterdam, Netherlands, 1061 AE
    - Onze Lieve Vrouwe Gasthuis, Locatie West
  - Amsterdam, Netherlands, 1091AC
    - Onze Lieve Vrouwe Gasthuis
  - Beverwijk, Netherlands, 1942 LE
    - Rode Kruis Ziekenhuis Beverwijk
  - Blaricum, Netherlands, 1261 AN
    - Tergooiziekenhuizen locatie Blaricum
  - Breda, Netherlands, 4818 CK
    - Amphia ziekenhuis
  - EDE, Netherlands, 6716 RP
    - Ziekenhuis Gelderse Vallei
  - Eindhoven, Netherlands, 5623 EJ
    - Catharina Ziekenhuis
  - Groningen, Netherlands, 9713 GZ
    - Universitair Medisch Centrum Groningen
  - Heerlen, Netherlands, 6419 PC
    - Zuyderland Medisch Centrum
  - Maastricht, Netherlands, 6229 HX
    - Maastricht University
  - Meppel, Netherlands, 7943 KA
    - Diaconessenhuis Meppel
  - Nieuwegein, Netherlands, 3435 CM
    - St. Antonius ziekenhuis, locatie Nieuwegein
  - Nijmegen, Netherlands, 6525 GL
    - Radboud Universitair Medisch Centrum
  - Rotterdam, Netherlands, 3045 PM
    - Franciscus Gasthuis
  - Zaandam, Netherlands, 1502 DV
    - De Heel - Zaans Medisch Centrum
  - Zutphen, Netherlands, 7207 AE
    - Gelre Ziekenhuis Zutphen
Poland
- - Bialystok, Poland, 15-765
    - KLIMED Marek Klimkiewicz
  - Bialystok, Poland, 15-276
    - Univ. Clinic Hosp, Bialystok
  - Bialystok, Poland, 15-879
    - ClinicMed Badurski i wspolnicy Spolka Jawna, Bialystok
  - Bielsko-Biala, Poland, 43-316
    - American Heart of Poland Sp. z o.o.
  - Bydgoszcz, Poland, 85231
    - NZOZ Centrum Medyczne KERmed
  - Chorzow, Poland, 32-500
    - Polsko-Amerykańskie Kliniki Serca
  - Dabrowa Gornicza, Poland, 41-300
    - American Heart of Poland Sp. z o.o.
  - Gdansk, Poland, 80-952
    - University Clinical Center, Gdansk
  - Gdansk, Poland, 80-286
    - Poradnia Kardiologiczna Jaroslaw Jurowiecki
  - Gdynia, Poland, 81-157
    - Indywidualna Specjalistyczna Praktyka Lekarska
  - Gdynia, Poland, 81-423
    - NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog.
  - Katowice, Poland, 40-211
    - Szpital Zakonu Bonifratow Sp. z o.o.
  - Kielce, Poland, 25525
    - Specialistic Cardiology&Hypertension Out-patient Clin,Kielce
  - Krakow, Poland, 30-082
    - Leszek Bryniarski Specialized Medical Cabinet
  - Krakow, Poland, 31-202
    - Krakow Specialistic Hospital of John Paul II
  - Lodz, Poland, 90-302
    - ETG Lodz
  - Lodz, Poland, 91-002
    - Nzoz Salus
  - Lodz, Poland, 94-255
    - Individual Specialized Practice
  - Lowicz, Poland, 99-400
    - Lowickie Cardiology Center
  - Nysa, Poland, 48-300
    - American Heart of Poland Sp. z o.o.
  - Oswiecim, Poland, 32-600
    - Medicome Sp. z o.o.
  - Piaseczno, Poland, 05-500
    - NZOZ HEUREKA, Piaseczno
  - Ruda Slaska, Poland, 41-709
    - Specialized Practice Dr. Janusz Spyra
  - Rzeszow, Poland, 35-055
    - Centrum Medyczne Medyk
  - Siedlce, Poland, 08-110
    - Lukmed Lukasz Wozniak
  - Skierniewice, Poland, 96-100
    - Etg Skierniewice
  - Staszow, Poland, 28-200
    - KO-MED Centra Kliniczne Staszow
  - Torun, Poland, 87-100
    - The Provincial Polyclinical Hospital in Torun
  - Tychy, Poland, 43-100
    - American Heart of Poland Sp. z o.o.
  - Ustron, Poland, 43-450
    - American Heart of Poland Sp. z o.o.
  - Warszawa, Poland, 02-793
    - Etg Warszawa
  - Warszawa, Poland, 02-097
    - Samodzielny Publiczny Centralny Szpital Kliniczny
  - Wroclaw, Poland, 50-981
    - 4. Military Clinical Hospital with Polyclinic SP ZOZ
  - Zgierz, Poland, 95-100
    - Zgierskie Center of Cardiology MED-PRO
  - Zychlin, Poland, 62-571
    - Specialist Hospital J. Dietla NZOZ Specialized Clinic "Gemini"
Romania
- - Balotesti, Romania, 077015
    - Spitalul Clinic De Urgenta "Prof. Dr. Agrippa Ionescu"
  - Brasov, Romania, 500283
    - C.M.D.T.A. NEOMED, Brasov
  - Bucharest, Romania, 011794
    - CMDTA Washington, Bucharest
  - Bucharest, Romania, 021659
    - Emergency Clinical Hospital 'Sf. Panteliomon'
  - Bucharest, Romania, 022328
    - Emergency University Hospital, Bucharest
  - Bucharest, Romania, 022328
    - Prof.C.C.Iliescu Hospital, National Institute of Cardiology
  - Bucharest, Romania, 050098
    - Emergency University Hospital, Bucharest
  - Bucuresti, Romania, 020125
    - Spitalul Clinic Colentina
  - Bucuresti, Romania, 050659
    - Spitalul Clinic "Prof. Dr. Theodor Burghele"
  - Bucuresti, Romania, 10192
    - Clinica Medicala Data Plus SRL
  - Craiova, Romania, 200505
    - S.C Cardiomed S.R.L
  - Deva, Romania, 330084
    - Spital Judetean Deva
  - Timisoara, Romania, 300043
    - S.C Medicali's S.R.L
  - Timisoara, Romania, 300723
    - Spitalul Clinic Judetean de Urgenta, Timisoara
Singapore
- - Singapore, Singapore, 119074
    - National University Hospital
  - Singapore, Singapore, 308433
    - Tan Tock Seng Hospital
  - Singapore, Singapore, 169609
    - National Heart Center
  - Singapore, Singapore, 768828
    - Khoo Teck Puat Hospital
South Africa
- - Alberton, South Africa, 1449
    - Cardiology Clinical Research
  - Bloemfontein, South Africa, 9301
    - Iatros International
  - Bloemfontein, South Africa, 9301
    - Universitas Hospital Cardiology Research
  - Cape Town, South Africa, 7500
    - TREAD Research
  - Cape Town, South Africa, 7500
    - Corbod Research
  - Cape Town, South Africa, 7530
    - Tiervlei Trial Centre
  - George, South Africa, 6529
    - Excellentis Clinical Trials
  - Johannesburg, South Africa, 1619
    - Clinresco
  - Johannesburg, South Africa, 1862
    - Chris Hani Baragwanath Hospital: Cardiology Department
  - Kempton Park, South Africa, 1619
    - MERC Research
  - Pretoria, South Africa, 181
    - Into Research
  - Somerset West, South Africa, 7130
    - Dr JM Engelbrecht
  - Worcester, South Africa, 6850
    - Clinical Projects Research
Spain
- - Barcelona, Spain, 08025
    - Hospital Santa Creu i Sant Pau
  - Barcelona, Spain, 08023
    - Hospital Quiron. I.C.U.
  - Barcelona, Spain, 08034
    - Hospital Sanitas Cima
  - El Palmar, Spain, 30120
    - Hospital Universitario Virgen de la Arrixaca
  - Madrid, Spain, 28034
    - Hospital Ramón y Cajal
  - Madrid, Spain, 28046
    - Hospital La Paz
  - Madrid, Spain, 28007
    - Hospital General Universitario Gregorio Maranon
  - Majadahonda, Spain, 28222
    - Hospital Puerta de Hierro
  - Malaga, Spain, 29010
    - Hospital Virgen de la Victoria
  - Santiago de Compostela, Spain, 15706
    - Hospital Clínico de Santiago
  - Sevilla, Spain, 41009
    - Hospital Virgen Macarena
  - Valencia, Spain, 46015
    - Hospital Arnau de Vilanova
  - Valencia, Spain, 46014
    - Hospital General Universitario de Valencia
United Kingdom
- - Barnet, United Kingdom, EN5 3DJ
    - Barnet General Hospital
  - Cardiff, United Kingdom, CF14 4XU
    - University Hospital of Wales
  - Eastleigh, United Kingdom, SO53 4ST
    - Park & St Francis Surgery
  - High Wycombe, United Kingdom, HP11 2TT
    - Wycombe General Hospital
  - Leicester, United Kingdom, LE3 9QP
    - Glenfield Hospital
  - London, United Kingdom, EC1A 7BE
    - St Bartholomew's Hospital
  - Newport, United Kingdom, PO30 5TG
    - St Mary's Hospital
  - Swansea, United Kingdom, SA6 6NL
    - Morriston Hospital
United States
- Alabama
  - Anniston, Alabama, United States, 36207
    - Pinnacle Research Group, LLC
  - Birmingham, Alabama, United States, 35249
    - University of Alabama at Birmingham
  - Huntsville, Alabama, United States, 35801
    - Heart Center Research, LLC
- California
  - Fresno, California, United States, 93701
    - University of California San Francisco
  - La Mesa, California, United States, 91942
    - La Mesa Cardiac Center
  - La Mesa, California, United States, 91942
    - Purushotham, Akther & Roshan Kotha, MD Inc.
  - Long Beach, California, United States, 90807
    - Long Beach Center For Clinical Research
  - Los Angeles, California, United States, 90073
    - VA Greater Los Angeles Healthcare System
  - Merced, California, United States, 95340
    - Merced Vein and Vascular Center
  - Northridge, California, United States, 91325
    - Valley Clinical Trials, Inc.
  - Orange, California, United States, 92865
    - University of California Irvine
  - Riverside, California, United States, 92506
    - Covigilant Research, LLC
  - San Francisco, California, United States, 94143
    - University of California San Francisco
  - Torrance, California, United States, 90502
    - University of California
  - Tustin, California, United States, 92780
    - Orange County Research Center
  - Vista, California, United States, 92083
    - Blue Coast Cardiology
- Colorado
  - Littleton, Colorado, United States, 80120
    - South Denver Cardiology Associates, PC
- Florida
  - Boca Raton, Florida, United States, 33434
    - Integrated Heart Care
  - Chiefland, Florida, United States, 32626
    - Southeast Clinical Research, LLC
  - Clearwater, Florida, United States, 33756
    - Morton Plant Mease Health Care
  - DeLand, Florida, United States, 32720
    - Accel Research Sites
  - Fort Lauderdale, Florida, United States, 33312
    - Integrative Research Associates
  - Inverness, Florida, United States, 34452
    - Nature Coast Clinical Research
  - Jacksonville, Florida, United States, 32216
    - Jacksonville Center for Clinical Research
  - Jacksonville, Florida, United States, 32216
    - East Coast Institute for Research, LLC
  - Miami, Florida, United States, 33144
    - Elite Clinical Research
  - Miami, Florida, United States, 33173
    - Cardiovascular Research Center of South Florida
  - Orlando, Florida, United States, 32806
    - Orlando Health Inc.
  - Ormond Beach, Florida, United States, 32174
    - Peninsula Research, Inc.
  - Safety Harbor, Florida, United States, 34695
    - Clearwater Cardiovascular Consultants
  - Sarasota, Florida, United States, 34239
    - Sarasota Memorial Hospital
  - Tampa, Florida, United States, 33606
    - University of South Florida
  - Tampa, Florida, United States, 33613
    - Advent Health Medical Group
- Georgia
  - Atlanta, Georgia, United States, 30303
    - Grady Clinical Research Center
  - Columbus, Georgia, United States, 31904
    - Columbus Regional Research Institute
  - Lawrenceville, Georgia, United States, 30046
    - Cardiovascular Group PC
  - Savannah, Georgia, United States, 31406
    - Meridian Clinical Research, LLC
  - Tucker, Georgia, United States, 30084
    - Atlanta Heart Specialists, LLC
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - Northwest Heart Clinical Research, LLC
  - Chicago, Illinois, United States, 60608
    - Mount Sinai Hospital
  - Naperville, Illinois, United States, 60540
    - Advocate Health and Hospitals Corporation
  - North Chicago, Illinois, United States, 60064
    - Captain James A. Lovell Federal Health Care Center
  - Rockford, Illinois, United States, 61107
    - Rockford CardioVascular Associates
- Indiana
  - Elkhart, Indiana, United States, 46514
    - Midwest Cardiovascular Research and Education Foundation
  - Indianapolis, Indiana, United States, 46237
    - St. Francis Medical Group-Indiana Heart Physicians, Inc
  - Richmond, Indiana, United States, 47374
    - Reid Hospital
  - South Bend, Indiana, United States, 46601
    - Beacon Medical Group Clinical Research
- Iowa
  - Des Moines, Iowa, United States, 50314
    - Iowa Heart Center
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Norton Heart Specialists
  - Owensboro, Kentucky, United States, 42303
    - Research Integrity, LLC
- Louisiana
  - Bossier City, Louisiana, United States, 71111
    - Grace Research, LLC
  - Monroe, Louisiana, United States, 71201
    - Clinical Trials of America, LLC
  - New Orleans, Louisiana, United States, 70112
    - LSU Health Sciences Center
- Maine
  - Lewiston, Maine, United States, 04240
    - Maine Research Associates
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Anne Arundel Medical Center
  - Baltimore, Maryland, United States, 21229
    - Maryland Cardiovascular Specialists
  - Baltimore, Maryland, United States, 21237
    - MedStar Health Research Institute
  - Beltsville, Maryland, United States, 20705
    - Metropolitan Cardiovascular Consultants
  - Oxon Hill, Maryland, United States, 20745
    - MD Medical Research
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center
  - Great Barrington, Massachusetts, United States, 01230
    - East Mountain Medical Associates, PC
- Michigan
  - Alpena, Michigan, United States, 49707
    - Alpena General Hospital
  - Petoskey, Michigan, United States, 49770
    - McLaren Northern Michigan Hospital
- Minnesota
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - Jackson Heart Clinic, P.A.
- Missouri
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Hospital of Kansas City
  - Saint Louis, Missouri, United States, 63110
    - Saint Louis University
  - Saint Louis, Missouri, United States, 63128
    - St. Louis Center for Clinical Research
  - Saint Louis, Missouri, United States, 63136
    - St. Louis Heart and Vascular, P.C.
- Montana
  - Billings, Montana, United States, 59101
    - Deaconess Billings Clinic Research Center
  - Bozeman, Montana, United States, 59718
    - Bozeman Health Clinical Research
- Nebraska
  - Grand Island, Nebraska, United States, 68803
    - Nebraska Heart Institute
  - Papillion, Nebraska, United States, 68046
    - CHI Health Midlands
- Nevada
  - Las Vegas, Nevada, United States, 89128
    - Palm Research Center
  - Las Vegas, Nevada, United States, 89109
    - Healthcare Partners LLC
- New Jersey
  - Bridgewater, New Jersey, United States, 08807
    - Advanced Heart Care, LLC
  - Manalapan, New Jersey, United States, 07726
    - Garden State Heart Care, PC
- New York
  - Albany, New York, United States, 12211
    - Capital Cardiology Associates, PC
  - Bronx, New York, United States, 10455
    - Chear Center LLC
  - Bronx, New York, United States, 10469
    - Cardiac Care and Vascular Medicine, PLLC
  - Cheektowaga, New York, United States, 14227
    - Trinity Medical WNY, PC
  - Manhasset, New York, United States, 11030
    - North Shore University Hospital
  - New Hyde Park, New York, United States, 11042
    - Long Island Cardiovascular Consultants
  - New York, New York, United States, 10035
    - Harlem Cardiology
  - New York, New York, United States, 10025
    - Mount Sinai - PRIME
  - Rosedale, New York, United States, 11422
    - Laurelton Heart Specialist, PC
  - Saratoga Springs, New York, United States, 12866
    - Saratoga Clinical Research, LLC
  - Southampton, New York, United States, 11968
    - Northwell Health
  - Stony Brook, New York, United States, 11794
    - Stony Brook University Medical Center
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - Asheville Cardiology Associates
  - Burlington, North Carolina, United States, 27215
    - Kernodle Clinic West
  - Chapel Hill, North Carolina, United States, 27599-5021
    - The University of North Carolina at Chapel Hill
  - Charlotte, North Carolina, United States, 28204
    - Novant Health Heart and Vascular Institute
  - Gastonia, North Carolina, United States, 28054
    - Clinical Research of Gastonia
  - Lenoir, North Carolina, United States, 28645
    - Clinical Trials of America, Inc
- Ohio
  - Cleveland, Ohio, United States, 44104-1702
    - Va Northeast Ohio Healthcare System
  - Marion, Ohio, United States, 43302
    - Rama Research LLC
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73135
    - South Oklahoma Heart Research Group
- Pennsylvania
  - Doylestown, Pennsylvania, United States, 18901
    - Doylestown Health Cardiology
  - Jersey Shore, Pennsylvania, United States, 17740
    - Lycoming Internal Medicine, Inc
  - Johnstown, Pennsylvania, United States, 15905
    - Richard M Kastelic and Associates
  - York, Pennsylvania, United States, 17403
    - York Hospital, WellSpan Health
- South Carolina
  - Charleston, South Carolina, United States, 29401
    - Lowcountry Center for Veterans Research
  - Columbia, South Carolina, United States, 29203
    - Palmetto Health
  - Rock Hill, South Carolina, United States, 29732
    - Clinical Research of Rock Hill
  - Spartanburg, South Carolina, United States, 29302
    - Palmetto Research Center, LLC
- South Dakota
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Research
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - The Stern Cardiovascular Center
  - Jackson, Tennessee, United States, 38301
    - Apex Cardiology/ Research Associates of Jackson
  - Memphis, Tennessee, United States, 38104
    - Methodist University Hospital
- Texas
  - Austin, Texas, United States, 78705
    - Seton Heart Institute
  - Dallas, Texas, United States, 75226
    - Baylor Heart and Vascular Hospital
  - Dallas, Texas, United States, 75226
    - Soltero Cardiovascular Research Center
  - Dallas, Texas, United States, 75390-8837
    - University of Texas Southwestern Medical Center
  - Fort Worth, Texas, United States, 76107
    - University of North Texas Health Science Center
  - Galveston, Texas, United States, 77555
    - University of Texas Medical Branch at Galveston
  - Houston, Texas, United States, 77030
    - The Methodist Hospital
  - Houston, Texas, United States, 77025
    - Angiocardiac Care of Texas
  - Houston, Texas, United States, 77084
    - Biopharma Informatic, Inc. Research Center
  - Katy, Texas, United States, 77493
    - Private Practice Leadership, LLC
  - Plano, Texas, United States, 75024
    - Baylor Scott and White Health
- Utah
  - Farmington, Utah, United States, 84025
    - Alpine Research Organization
- Virginia
  - Chester, Virginia, United States, 23836
    - Cardiac Health Management Network, P.C.
  - Danville, Virginia, United States, 24541
    - Cardiology Consultants of Danville, Inc
  - Manassas, Virginia, United States, 20109
    - Carient Heart and Vascular
  - Richmond, Virginia, United States, 23249
    - Hunter Holmes McGuire VA Medical Center
  - Richmond, Virginia, United States, 23298
    - Medical College of Virginia Hospitals
  - Roanoke, Virginia, United States, 24014
    - Roanoke Heart Institute PLC
  - Salem, Virginia, United States, 24153
    - Salem VA Medical Center
- Washington
  - Seattle, Washington, United States, 98101
    - Virginia Mason Medical Center
- Wisconsin
  - Green Bay, Wisconsin, United States, 54301
    - Cardiology Associates of Bellin Health
  - Madison, Wisconsin, United States, 53713
    - Meriter Wisconsin Heart
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic
  - Wausau, Wisconsin, United States, 54401
    - Aspirus Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion criteria:

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

Exclusion criteria:

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,
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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo once daily
Experimental: 10 mg Empagliflozin	Drug: Empagliflozin once daily Other Names: JARDIANCE, JARDIANZ, GIBTULIO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From randomization until completion of the planned treatment phase, up to 1403 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Reported is the total number of adjudicated HHF events (first and recurrent) which occurred.	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.	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".	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.	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).	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 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.	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 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.	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 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.	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.	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.	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.	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.	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.	Occurrence of all-cause hospitalisation (first and recurrent). Total number of all cause hospitalisations is reported.	From randomization until completion of the planned treatment phase, up to 1403 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2017

Primary Completion (Actual)

April 26, 2021

Study Completion (Actual)

April 26, 2021

Study Registration Dates

First Submitted

February 16, 2017

First Submitted That Met QC Criteria

February 16, 2017

First Posted (Actual)

February 20, 2017

Study Record Updates

Last Update Posted (Actual)

June 6, 2022

Last Update Submitted That Met QC Criteria

June 3, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

1245.110
2016-002278-11 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Heart Failure

Clinical Trials on Placebo

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