EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction)
NCT ID: NCT04509674
Last Updated: 2025-01-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
6522 participants
INTERVENTIONAL
2020-12-16
2023-11-05
Brief Summary
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People who are in hospital may join the study soon after being treated for their heart attack. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes 1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. All participants continue their standard treatment. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. Empagliflozin is a medicine that helps people with type 2 diabetes to lower their blood sugar. Researchers think that empagliflozin might also help people after heart attack who are at risk for heart failure, whether or not they have diabetes.
Participants are in the study for about 1 to 2 years. During this time, there are about 4 visits inperson, 2 visits are done either by phone or by use of an mobile application. Results between the empagliflozin and placebo groups are compared. The doctors also regularly check the general health of the participants.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Empagliflozin 10 mg
Empagliflozin
Empagliflozin
Placebo
Placebo
Placebo
Interventions
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Empagliflozin
Empagliflozin
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
3. Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
4. Diagnosis of spontaneous Acute Myocardial Infarction (AMI): ST-Elevation Myocardial Infarction (STEMI) or Non-ST Elevation Myocardial Infarction (NSTEMI) with randomisation to occur no later than 14 calendar days after hospital admission. For patients with an in-hospital Myocardial Infarction (MI) as qualifying event, randomization must still occur within 14 days of hospital admission.
5. High risk of HF, defined as EITHER
1. Symptoms (e.g. dyspnea; decreased exercise tolerance; fatigue), or signs of congestion (e.g. pulmonary rales, crackles or crepitations; elevated jugular venous pressure; congestion on chest X-ray), that require treatment (e.g. augmentation or initiation of oral diuretic therapy; i.v. diuretic therapy; i.v. vasoactive agent; mechanical intervention etc.) at any time during the hospitalization.
OR
2. Newly developed Left Ventricular Ejection Fraction (LVEF) \< 45% as measured by echocardiography, ventriculography, cardiac Computer Tomography (CT), Magnetic Resonance Imaging (MRI) or radionuclide imaging during index hospitalisation.
6. In addition at least one of the following risk factors:
* Age \> 65 years,
* Newly developed LVEF \< 35%,
* Prior MI (before index MI) documented in medical records,
* Estimated Glomerular Filtration Rate (eGFR) \< 60 ml/min/1.73m2 (using Chronic Kidney Disease Epidemiology Collaboration Equation (CKD-EPI) formula based on creatinine from local lab at any time during index hospitalisation),
* Atrial fibrillation (persistent or permanent ; if paroxysmal, only valid if associated with index MI),
* Type 2 diabetes mellitus (prior or new diagnosis),
* N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) \>1,400 pg/mL for patients in sinus rhythm, \>2,800 pg/mL if atrial fibrillation; Brain Natriuretic Peptide (BNP) \>350 pg/mL for patients in sinus rhythm, \>700 pg/mL if atrial fibrillation, measured at any time during hospitalisation,
* Uric acid \>7.5 mg/dL (\>446 μmol/L), measured at any time during hospitalisation,
* Pulmonary Artery Systolic Pressure \[or right ventricular systolic pressure\] \>40 mmHg (non-invasive \[usually obtained from clinically indicated post-MI echocardiography\] or invasive, at any time during hospitalisation),
* Patient not revascularized (and no planned revascularization) for the index MI (Includes e.g. patients where no angiography is performed, unsuccessful revascularization attempts, diffuse atherosclerosis not amenable for intervention; but does NOT include if revascularization was not performed due to nonobstructive coronary arteries),
* 3-vessel coronary artery disease at time of index MI,
* Diagnosis of peripheral artery disease (extracoronary vascular disease, e.g. lower extremity artery disease or carotid artery disease).
Exclusion Criteria
2. Systolic blood pressure \< 90 mmHg at randomisation.
3. Cardiogenic shock or use of i.v. inotropes in last 24 hours before randomisation.
4. Coronary Artery Bypass Grafting planned at time of randomisation.
5. Current diagnosis of Takotsubo cardiomyopathy.
6. Any current severe (stenotic or regurgitant) valvular heart disease.
7. eGFR \< 20 ml/min/1.73m2 (using CKD-EPI formula based on most recent creatinine from local lab during index hospitalisation) or on dialysis.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Advanced Cardiovascular LLC
Alexander City, Alabama, United States
Grandview Medical Center
Birmingham, Alabama, United States
Heart Center Research, LLC
Huntsville, Alabama, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, United States
Arkansas Cardiology, PA
Little Rock, Arkansas, United States
Comprehensive Cardiovascular Medical Group
Bakersfield, California, United States
Valley Clinical Trials, Inc.
Covina, California, United States
Cardiovascular Innovation and Research Center
Long Beach, California, United States
University of California Los Angeles
Los Angeles, California, United States
InvivoCure
Mission Hills, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Valley Clinical Trials, Inc.
Pasadena, California, United States
Kaiser Permanente
San Diego, California, United States
San Diego Cardiac Center
San Diego, California, United States
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Interventional Cardiology Medical Group
West Hills, California, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
Integrative Research Associates
Fort Lauderdale, Florida, United States
University of Florida Health Jacksonville
Jacksonville, Florida, United States
Cardiology Partners Clinical Research Institute
Palm Beach Gardens, Florida, United States
Charlotte Heart Group Research Center
Port Charlotte, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Cardiovascular Consultants of South Georgia, LLC
Thomasville, Georgia, United States
Atlanta Heart Specialists, LLC
Tucker, Georgia, United States
Advanced Heart Care, LLC, Medicoricum, LLC
Fairview Heights, Illinois, United States
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, United States
Cardiovascular Research of Northwest Indiana, LLC
Munster, Indiana, United States
Reid Physician Associates
Richmond, Indiana, United States
Midwest Heart and Vascular Specialists
Overland Park, Kansas, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Cardiovascular Specialists of Central Maryland
Columbia, Maryland, United States
Shady Grove Adventist Hospital
Rockville, Maryland, United States
Healthy Heart Cardiology
Grand Rapids, Michigan, United States
Western Michigan University
Kalamazoo, Michigan, United States
Mid Michigan Medical Center
Midland, Michigan, United States
Michigan Heart, PC
Ypsilanti, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States
Missouri Cardiovascular Specialists, LLP
Columbia, Missouri, United States
University of Missouri Health System
Columbia, Missouri, United States
North Kansas City Hospital
North Kansas City, Missouri, United States
Gateway Cardiology, PC
St Louis, Missouri, United States
St. Louis Heart and Vascular, P.C.
St Louis, Missouri, United States
Holy Name Medical Center
Hackensack, New Jersey, United States
AtlantiCare
Pomona, New Jersey, United States
The Heart House
Vineland, New Jersey, United States
SJH Cardiology Associates
Liverpool, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Asheville Cardiology Associates
Asheville, North Carolina, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States
Medication Management, LLC
Greensboro, North Carolina, United States
North Carolina Heart and Vascular
Raleigh, North Carolina, United States
Trinity Health Center Medical Arts
Minot, North Dakota, United States
Aultman Hospital
Canton, Ohio, United States
Cincinnati VA Medical Center
Cincinnati, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Oklahoma Heart Hospital Research Foundation, Incorporated
Oklahoma City, Oklahoma, United States
South Oklahoma Heart Research Group
Oklahoma City, Oklahoma, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Guthrie Medical Group PC
Sayre, Pennsylvania, United States
Upstate Cardiology, PA
Greenville, South Carolina, United States
Carolina Heart Specialists, LLC
Lancaster, South Carolina, United States
Monument Health
Rapid City, South Dakota, United States
Centennial Heart Cardiovascular Consultants, LLC
Nashville, Tennessee, United States
Parkway Cardiology Associates
Oak Ridge, Tennessee, United States
Cardiovascular Research of Knoxville
Powell, Tennessee, United States
Texas Health Presbyterian Hospital Allen
Allen, Texas, United States
Amarillo Heart Clinical Research Institute, Incorporated
Amarillo, Texas, United States
Pharmatex Research
Amarillo, Texas, United States
Dallas VA Medical Center
Dallas, Texas, United States
Baylor Scott and White Health
Plano, Texas, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, United States
Revival Research Institute, LLC.
Sherman, Texas, United States
Cardiovascular Associates of East Texas, PA
Tyler, Texas, United States
Carient Heart and Vascular
Manassas, Virginia, United States
Riverside Regional Medical Center
Newport News, Virginia, United States
Tidewater Physicians Multispecialty Group
Newport News, Virginia, United States
Sentara Hospitals
Norfolk, Virginia, United States
Roanoke Heart Institute PLC
Roanoke, Virginia, United States
Instituto Cardiovascular de Buenos Aires
Belgrano, , Argentina
Fundacion Sanatorio Güemes
Ciudad Autonoma Buenos Aires, , Argentina
Centro de Investigacion Clinica Coronel Suarez
Coronel Suárez, , Argentina
Instituto de Cardiologia de Corrientes
Corrientes, , Argentina
Hospital Italiano de Córdoba
Córdoba, , Argentina
Sanatorio Allende
Córdoba, , Argentina
Centro Medico Luquez
Córdoba, , Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, , Argentina
Clinica Privada del Prado
Córdoba, , Argentina
Fundación Favaloro para la Docencia e Investigación Medica
Montserrat, , Argentina
Sanatorio Modelo de Quilmes
Quilmes, , Argentina
Instituto Cardiovascular de Rosario
Rosario, , Argentina
Sanatorio Delta
Rosario, , Argentina
Sanatorio Parque
Rosario, , Argentina
Corporacion Medica de Gral. San Martin S.A.
San Martín, , Argentina
Centro Privado de Cardiologia
San Miguel de Tucumán, , Argentina
Clinica U.O.M.
San Nicolás, , Argentina
Sanatorio Diagnóstico
Santa Fe, , Argentina
Hospital "Dr. José Maria Cullen"
Santa Fé, , Argentina
Clinica Privada Fusavim SRL
Villa María, , Argentina
Concord Repatriation General Hospital
Concord, New South Wales, Australia
South Western Sydney Local Health District
Liverpool, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Alfred Hospital
Melbourne, Victoria, Australia
JMF Clinica Do Coracao LTDA
Aracaju - SE, , Brazil
Hospital Santa Isabel
Balneário Camboriú, , Brazil
Hospital Madre Teresa
Belo Horizonte, , Brazil
Hospital do Coracao do Brasil
Brasília, , Brazil
Hospital Angelina Caron
Campina Grande do Sul, , Brazil
Centro Especializado em Cardiol Loema Instituto de Pesq Clin
Campinas, , Brazil
IPECC - Instituto de Pesquisa Clínica de Campinas
Campinas, , Brazil
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Fortaleza, , Brazil
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
Goiânia, , Brazil
Hospital Regional Hans Dieter Schmidt
Joinville, , Brazil
Santa Casa de Misericórdia de Marília
Marília, , Brazil
Hospital São Vicente de Paulo
Passo Fundo, , Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, , Brazil
Instituto de Cardiologia Rio Grande do Sul
Porto Alegre, , Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre, , Brazil
Hospital Agamenon Magalhaes
Recife, , Brazil
Fundacao de apoio ao ensino e assitencia HCFMRP
Ribeirão Preto, , Brazil
Hospital Copa D'or
Rio de Janeiro, , Brazil
Instituto de Ensino E Pesquisa Do Hospital Da Bahia
Salvador, , Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, , Brazil
Hospital de Base - Fac Med de Sao Jose do Rio Preto
São José do Rio Preto, , Brazil
Hospital Samaritano
São Paulo, , Brazil
Hospital Sao Luiz Jabaquara
São Paulo, , Brazil
Hospital Sao Luiz Morumbi
São Paulo, , Brazil
Hospital das Clínicas de Sao Paulo - INCOR
São Paulo, , Brazil
Santa Casa de Votuporanga
Votuporanga, , Brazil
Multiprofile Hospital For Active Treatment Pulse AD
Blagoevgrad, , Bulgaria
Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" AD
Gabrovo, , Bulgaria
Multiprofile Hospital for Active Treatment AD Haskovo
Haskovo, , Bulgaria
Multiprofile Hospital For Active Treatment - Pazardzhik AD
Pazardzhik, , Bulgaria
Specialized Hospital for Active Treatment Sv. Georgi - Pernik
Pernik, , Bulgaria
Medical Center Medconsult Pleven LTD
Pleven, , Bulgaria
Multiprofile Hospital for Active Treatment Heart and Brain EAD
Pleven, , Bulgaria
SHAT in Cardiology EAD, Pleven
Pleven, , Bulgaria
Hospital MHAT Plovdiv, AD
Plovdiv, , Bulgaria
National Heart Hospital, Sofia
Sofia, , Bulgaria
City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatement "Alexandrovska" EAD
Sofia, , Bulgaria
UMHAT "Tsaritsa Yoannalsul"
Sofia, , Bulgaria
Medical Military Academy MHAT Sofia
Sofia, , Bulgaria
Multiprofile Hospital MHATEM 'Pirogov', Sofia
Sofia, , Bulgaria
MHAT Sv.Anna, Clinic of Internal Diseases, Sofia
Sofia, , Bulgaria
Hospital Trakia Park
Stara Zagora, , Bulgaria
Heritage Medical Research Clinic
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, Canada
Royal Inland Hospital
Kamloops, British Columbia, Canada
Surrey Memorial Hospital
Surrey, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
GA Research Associates Ltd.
Moncton, New Brunswick, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
William Osler Health Centre
Brampton, Ontario, Canada
Queen's University
Kingston, Ontario, Canada
One Heart Care Ventures
Mississauga, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Peterborough Regional Health Centre
Peterborough, Ontario, Canada
Heart Health Institute
Scarborough Village, Ontario, Canada
Women's College Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
IUCPQ (Laval University)
Sainte-Foy, Quebec, Canada
CIUSSS de l Estrie-CHUS
Sherbrooke, Quebec, Canada
CSSS du Sud de Lanaudiere - Hopital Pierre-Le Gardeur
Terrebonne (Lachenaie), Quebec, Canada
CIUSSS de la Mauricie-et-du-Centre-du-Quebec
Trois-Rivières, Quebec, Canada
Prairie Vascular Research Inc.
Regina, Saskatchewan, Canada
Oakville Trafalgar Memorial Hospital
Oakville, , Canada
Beijing Chao-Yang Hospital
Beijing, , China
Chinese PLA General Hospital
Beijing, , China
China-Japan Friendship Hospital
Beijing, , China
Peking University First Hospital
Beijing, , China
Beijing Luhe Hospital Capital Medical University
Beijing, , China
Changsha Central Hospital
Changsha, , China
Xiangya Hospital, Central South University
Changsha, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
The First Affiliated Hospital of Harbin Medical University
Haerbin, , China
Hainan General Hospital
Haikou, , China
Shulan(Hanghzhou) Hospital
Hangzhou, , China
Zhejiang Hospital
Hangzhou, , China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, , China
The Second Affiliated Hospital of Lanzhou Medical University
Lanzhou, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, , China
People's Hospital of Liaoning Province
Shenyang, , China
Peking University Shenzhen Hospital
Shenzhen, , China
Renmin Hospital of Wuhan University
Wuhan, , China
Aalborg Universitetsshospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus N, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Frederiksberg Hospital
Frederiksberg, , Denmark
Herlev and Gentofte Hospital
Herlev, , Denmark
Slagelse Sygehus
Slagelse, , Denmark
HOP Sud Francilien
Corbeil-Essonnes, , France
HOP CHU de Grenoble
Grenoble, , France
CHRU Lille
Lille, , France
Hospital de Saint Joseph et Saint Luc
Lyon, , France
HOP Bichat
Paris, , France
CHU Rouen
Rouen, , France
HOP Trousseau
Tours, , France
HOP Brabois
Vandœuvre-lès-Nancy, , France
SLK-Kliniken Heilbronn GmbH
Bad Friedrichshall, , Germany
Kerckhoff-Klinik, Bad Nauheim
Bad Nauheim, , Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Bonn AöR
Bonn, , Germany
Bremer Institut für Herz- und Kreislaufforschung (BIHKF) am Klinikum Links der Weser
Bremen, , Germany
Klinikum Coburg gGmbH
Coburg, , Germany
St. Johannes Hospital Dortmund
Dortmund, , Germany
Städtisches Klinikum Dresden
Dresden, , Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
Klinikum Frankfurt Höchst GmbH
Frankfurt am Main, , Germany
Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH
Freiburg I. Breisgau, , Germany
Asklepios Kliniken GmbH & Co. KGaA
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Ambulantes Herzzentrum Kassel
Kassel, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Katholisches Klinikum Mainz
Mainz, , Germany
Clemenshospital
Münster, , Germany
Kardiologische Praxis Papenburg
Papenburg, , Germany
Universitätsklinikum Regensburg
Regensburg, , Germany
Lausmed Kft. Outpatient Unit of Internal Medicine
Baja, , Hungary
Buda Hospital of the Hospitaller Order of Saint John of God
Budapest, , Hungary
Semmelweis University
Budapest, , Hungary
St. Imre Hospital, Budapest
Budapest, , Hungary
Semmelweis University
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
Jahn Ferenc Del-Pest Hospital
Budapest, , Hungary
University Debrecen Hospital
Debrecen, , Hungary
Csongrad Megyei Eu. Ellato Kozp. Hodmezovasarhely-Mako
Hódmezővásárhely, , Hungary
Somogy County Kaposi Mor Teaching Hospital
Kaposvár, , Hungary
Bacs-Kiskun Megyei Onkormanyzat Hospital
Kecskemét, , Hungary
Pest Megyei Flor Ferenc Hospital
Kistarcsa, , Hungary
University of Szeged
Szeged, , Hungary
Fejer County Saint George University Teaching Hospital
Székesfehérvár, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet
Szolnok, , Hungary
Zala County Hospital, Zalaegerszeg
Zalaegerszeg, , Hungary
Kamalnayan Bajaj Hospital
Aurangabad, , India
Sri Jayadeva Institute of Cardiovascular Sciences & Research
Bangalore, , India
Narayana Institute of Cardiac Sciences
Bangalore, , India
KLES Dr.Prabhakar Kore Hospital and Medical Research Centre
Belagavi, , India
Madras Medical Mission,
Chennai, , India
Eternal Heart Care Centre & Research Institute Pvt. Ltd.
Jaipur, , India
KEM Hospital and Seth G S Medical College
Mumbai, , India
Sion Hospital (Lokmanya Tilak Municipal Hospital)
Mumbai, , India
Government Medical College & Hospital
Nagpur, , India
GB Pant Institute of Post Graduate Medical Education and Research
New Delhi, , India
Max Superspeciality Hospital
New Delhi, , India
Sir Gangaram Hospital
New Delhi, , India
Sahyadri Speciality Hospital
Pune, , India
Haemek Medical Center
Afula, , Israel
Assuta Medical Center
Ashdod, , Israel
Barzilai Medical Center
Ashkelon, , Israel
Assaf Harofe Medical Center
Beer Yaacov, , Israel
Soroka Univ. Medical Center
Beersheba, , Israel
Hillel Yaffe Medical Center, Hadera
Hadera, , Israel
Rambam Medical Center
Haifa, , Israel
Bnei Zion Medical Center, Haifa
Haifa, , Israel
Lady Davis Carmel Medical Center
Haifa, , Israel
Hadassah Medical Center, Ein-Karem
Jerusalem, , Israel
Shaare Zedek Medical Center, Jerusalem 91031
Jerusalem, , Israel
Hadassah Medical Center, Ein-Karem
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
West.Galilee Med.Cent.Naharia
Nahariya, , Israel
Rabin Medical Center Beilinson
Petah Tikva, , Israel
Rabin Medical Center Beilinson
Petah Tikva, , Israel
The Chaim Sheba Medical Center Tel HaShomer
Ramat Gan, , Israel
Kaplan Medical Center
Rehovot, , Israel
Ziv Medical Center
Safed, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Baruch Padeh Medical Center
Tiberias, , Israel
Kasugai Municipal Hospital
Aichi, Kasugai, , Japan
Toyota Memorial Hospital
Aichi, Toyota, , Japan
Chibanishi General Hospital
Chiba, Matsudo, , Japan
Seikeikai New Tokyo Heart Clinic
Chiba, Matsudo, , Japan
Saiseikai Fukuoka General Hospital
Fukuoka, Fukuoka, , Japan
Gifu Prefectural General Medical Center
Gifu, Gifu, , Japan
Ogaki Municipal Hospital
Gifu, Ogaki, , Japan
Hiroshima General Hospital
Hatsukaichi, , Japan
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima, , Japan
Hyogo Brain and Heart Center
Hyogo, Himeji, , Japan
Ibaraki Prefectural Central Hospital
Ibaraki, Kasama, , Japan
Tsuchiura Kyodo General Hospital
Ibaraki, Tsuchiura, , Japan
Ishikawa Prefectural Central Hospital
Ishikawa, Kanazawa, , Japan
Juntendo University Shizuoka Hospital
Izunokuni, , Japan
Tokai University Hospital
Kanagawa, Isehara, , Japan
Sagamihara Kyodo Hospital
Kanagawa, Sagamihara, , Japan
Yokohama City University Medical Center
Kanagawa, Yokohama, , Japan
Fukuoka Tokushukai Hospital
Kasuga, , Japan
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, , Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, , Japan
Kusatsu General Hospital
Kusatsu, , Japan
Miyazaki Medical Association Hospital
Miyazaki, , Japan
Nagano Chuo Hospital
Nagano, Nagano, , Japan
Osaka Police Hospital
Osaka, Osaka, , Japan
Kagawa Prefectural Central Hospital
Takamatsu, , Japan
Tokushima Prefectural Central Hospital
Tokushima, , Japan
St. Luke's International Hospital
Tokyo, Chuo-ku, , Japan
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu, , Japan
Showa University Fujigaoka Hospital
Yokohama, , Japan
Jeroen Bosch Ziekenhuis-Hertogenbosch
's-Hertogenbosch, , Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, , Netherlands
Meander Medisch Centrum
Amersfoort, , Netherlands
Amsterdam UMC Locatie VUMC
Amsterdam, , Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Rijnstate Hospital
Arnhem, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
IJsselland Ziekenhuis
Capelle aan den IJssel, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Admiraal de Ruyter Ziekenhuis
Goes, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Spaarne Ziekenhuis
Haarlem, , Netherlands
Zuyderland Medisch Centrum
Heerlen, , Netherlands
Tergooi Ziekenhuis
Hilversum, , Netherlands
Vasculair Onderzoek Centrum
Hoorn, , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
Leids Universitair Medisch Centrum (LUMC)
Leiden, , Netherlands
Alrijne Ziekenhuis
Leiden, , Netherlands
Ziekenhuis Rivierenland
Tiel, , Netherlands
Tweesteden Ziekenhuis, locatie Tilburg
Tilburg, , Netherlands
Isala Zwolle
Zwolle, , Netherlands
American Heart of Poland
Bełchatów, , Poland
Univ. Clinic Hosp, Bialystok
Bialystok, , Poland
American Heart of Poland Sp. z o.o.
Bielsko-Biala, , Poland
American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre
Chorzów, , Poland
American Heart of Poland Sp. z o.o.
Dąbrowa Górnicza, , Poland
NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog.
Gdynia, , Poland
Silesian Medical University in Katowice
Katowice, , Poland
American Heart of Poland Sp. z o.o.
Kędzierzyn-Koźle, , Poland
University Hospital in Krakow
Krakow, , Poland
The John Paul II Hosp.,Dept.of Coronary Heart Disease,Krakow
Krakow, , Poland
Podhalanski Special.Hosp,Intern.Med&Cardiology Dept,Nowy Tag
Nowy Targ, , Poland
Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego
Ostrołęka, , Poland
Medicome Limited Liability Company
Oświęcim, , Poland
Independent Public Healthcare, Dept. of Cardiology, Pulawy
Puławy, , Poland
American Heart of Poland Sp. z o.o.
Sztum, , Poland
American Heart of Poland Sp. z o.o.
Tychy, , Poland
Central Hospital of Medical Academy, Warsaw
Warsaw, , Poland
Instytut Kardiologii, Warszawa
Warsaw, , Poland
Dr Alfred Sokołowski Specialist Hospital
Wałbrzych, , Poland
Jan Mikulicz-Radecki UnivClinic Hosp,Cardiology Dept,Wroclaw
Wroclaw, , Poland
4. Military Clinical Hospital with Polyclinic SP ZOZ
Wroclaw, , Poland
Emergency Clinical County Hospital, Baia Mare
Baia Mare, , Romania
Spitalul Clinic De Urgenta "Prof. Dr. Agrippa Ionescu"
Baloteşti, , Romania
Spitalul Clinic Judetean de Urgenta Brasov
Brasov, , Romania
Spitalul Judetean de Urgenta Braila
Brăila, , Romania
Military Central Clinical Emergency Hospital
Bucharest, , Romania
Elias Emergency Hospital, Bucharest
Bucharest, , Romania
Prof.C.C.Iliescu Hospital, National Institute of Cardiology
Bucharest, , Romania
Emergency Clinical Hospital "Bagdasar-Arseni"
Bucharest, , Romania
Emergency University Hospital, Bucharest
Bucharest, , Romania
Heart Institute "Niculae Stancioiu", Cluj Napoca
Cluj-Napoca, , Romania
Clincal Reabilitation Hospital, Cluj Napoca
Cluj-Napoca, , Romania
Spitalul Clinic Judetean, Craiova
Craiova, , Romania
Cardiovascular Diseases Institute "Prof. Georgescu", Iasi
Iași, , Romania
SC Cardiomed SRL, Iasi
Iași, , Romania
SC Endodigest SRL
Oradea, , Romania
Sal Med Srl
Piteşti, , Romania
Emergency County Clinical Hospital, Sibiu
Sibiu, , Romania
Centrul Medical Cardiomed
Târgu Mureş, , Romania
Country Clinical Emergency Hospital, Targu-Mures
Târgu Mureş, , Romania
Cardiology and Cardiovascular Rehabilitation Clinic
Timișoara, , Romania
First City Clinical Hospital named after E. E. Volosevich
Arkhangelsk, , Russia
Regional Clinical Hospital, Kirov
Kirov, , Russia
Regional Clinical Hospital No.1 named after Professor. S.V. Ochapovskiy
Krasnodar, , Russia
State Healthcare Institution Clinical Hosp. No. 51, Moscow
Moscow, , Russia
Reg.Clin.Hosp.n.a.Semashko
Nizhny Novgorod, , Russia
Penza Regional Clinical Hospital named after N.N.Burdenko
Penza, , Russia
Republic Kareliya Republican Hosp. named after V.A. Baranov
Petrozavodsk, , Russia
GUZ Ryazanskiy Regional Clin. Cardiology Dispensary, Ryazan
Ryazan, , Russia
Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine
Saint Petersburg, , Russia
Medical Academy named after I. Mechnikov, St. Petersburg
Saint Petersburg, , Russia
Samara Regional Clinical Cardiology Clinic, Day Hosp. Dept.
Samara, , Russia
Saratov State Med.Univ.n.a.Razumovskogo
Saratov, , Russia
Saratov Regional Cardiac Center
Saratov, , Russia
Komi Republican Cardiological Dispensary
Syktyvkar, , Russia
Regional clinical hospital, Tver
Tver', , Russia
Tyumen Cardiology Center, Dept.of Cardiac Arrhythmia
Tyumen, , Russia
State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr
Volgograd, , Russia
Institute for Cardiovascular diseases Dedinje
Belgrade, , Serbia
University Clinical Center of Serbia
Belgrade, , Serbia
Clinical Hospital Center Dr. Dragisa Misovic
Belgrade, , Serbia
Clinical Medical Center Zvezdara, Belgrade
Belgrade, , Serbia
Institute of Cardiovascular Diseases
Kamenitz, , Serbia
University Clinical Center of Kragujevac
Kragujevac, , Serbia
General Hospital Leskovac
Leskovac, , Serbia
University Clinical Center Nis
Niš, , Serbia
Institute for Treatment and Rehabilitation, Niska Banja
Niška Banja, , Serbia
General Hospital Pancevo
Pančevo, , Serbia
General Hospital Sremska Mitrovica
Sremska Mitrovica, , Serbia
General Hospital Subotica, Internal Medicine
Subotica, , Serbia
Health Center Uzice
Užice, , Serbia
Health Centre Zajecar
Zaječar, , Serbia
General Hospital - Djordje Joanovic
Zrenjanin, , Serbia
Bucheon Sejong Hospital
Bucheon-si, , South Korea
Pusan National Univ. Hosp
Busan, , South Korea
Chungbuk National University Hospital
Cheongiu, , South Korea
Chungnam National University Hospital
Daejoen, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Yonsei University Wonju Severance Christian Hospital
Wonju-si, Gangwon State, , South Korea
Hospital Germans Trias i Pujol
Badalona, , Spain
University Hospital of Bellvitge
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitari Joan XXIII
Tarragona, , Spain
Complejo Hospitalario Universitario de Vigo
Vigo, , Spain
Cherkasy Regional Cardiological Center
Cherkasy, , Ukraine
City Joint Emergency Hospital, Dnepropetrovsk
Dnipro, , Ukraine
Ivano-Frankivsk City Central Clinical Hospital
Ivano-Frankivsk, , Ukraine
Clinical Treatment and Diagnostic Center of the Limited Liability Company "SIMEDGROUP"
Ivano-Frankivsk, , Ukraine
L.T. Malaya Institute of Therapy AMS of Ukraine
Kharkiv, , Ukraine
Reg.Clin.Hosp.Non-Commercial Enterprise
Kharkiv, , Ukraine
CI of Healthcare Kharkiv CCH #8, Kharkiv
Kharkiv, , Ukraine
Khmelnytskyi Regional Hospital
Khmelnytskyi, , Ukraine
Kiev City Clinical Hospital No. 5
Kiev, , Ukraine
SI NSC M.D. Strazhesko Institute Cardiology of NAMSU, Kyiv
Kiev, , Ukraine
City Clinical Hospital No. 1, Kiev
Kiev, , Ukraine
Kiev Emergency Care Hospital
Kiev, , Ukraine
Lutsk City Clinical Hospital
Lutsk, , Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
Lviv, , Ukraine
Odesa Regional Clinical Hospital
Odesa, , Ukraine
Regional Clinical Hospital, Ternopil
Ternopil, , Ukraine
Municipal Non-Profit Enterprise "Zakarpattia Regional Clinical Center of Cardiology and Cardiac Surgery" of Zakarpattia Regional Council
Uzhhorod, , Ukraine
Zhytomyr Regional Clinical Hospital, Dept. Endocrinology
Zhytomyr, , Ukraine
Countries
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References
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Udell JA, Petrie MC, Jones WS, Anker SD, Harrington J, Mattheus M, Seide S, Amir O, Bahit MC, Bauersachs J, Bayes-Genis A, Chen Y, Chopra VK, Figtree G, Ge J, Goodman SG, Gotcheva N, Goto S, Gasior T, Jamal W, Januzzi JL, Jeong MH, Lopatin Y, Lopes RD, Merkely B, Martinez-Traba M, Parikh PB, Parkhomenko A, Ponikowski P, Rossello X, Schou M, Simic D, Steg PG, Szachniewicz J, van der Meer P, Vinereanu D, Zieroth S, Brueckmann M, Sumin M, Bhatt DL, Hernandez AF, Butler J. Left Ventricular Function, Congestion, and Effect of Empagliflozin on Heart Failure Risk After Myocardial Infarction. J Am Coll Cardiol. 2024 Jun 11;83(23):2233-2246. doi: 10.1016/j.jacc.2024.03.405. Epub 2024 Apr 6.
Butler J, Jones WS, Udell JA, Anker SD, Petrie MC, Harrington J, Mattheus M, Zwiener I, Amir O, Bahit MC, Bauersachs J, Bayes-Genis A, Chen Y, Chopra VK, Figtree G, Ge J, Goodman SG, Gotcheva N, Goto S, Gasior T, Jamal W, Januzzi JL, Jeong MH, Lopatin Y, Lopes RD, Merkely B, Parikh PB, Parkhomenko A, Ponikowski P, Rossello X, Schou M, Simic D, Steg PG, Szachniewicz J, van der Meer P, Vinereanu D, Zieroth S, Brueckmann M, Sumin M, Bhatt DL, Hernandez AF. Empagliflozin after Acute Myocardial Infarction. N Engl J Med. 2024 Apr 25;390(16):1455-1466. doi: 10.1056/NEJMoa2314051. Epub 2024 Apr 6.
Hernandez AF, Udell JA, Jones WS, Anker SD, Petrie MC, Harrington J, Mattheus M, Seide S, Zwiener I, Amir O, Bahit MC, Bauersachs J, Bayes-Genis A, Chen Y, Chopra VK, A Figtree G, Ge J, G Goodman S, Gotcheva N, Goto S, Gasior T, Jamal W, Januzzi JL, Jeong MH, Lopatin Y, Lopes RD, Merkely B, Parikh PB, Parkhomenko A, Ponikowski P, Rossello X, Schou M, Simic D, Steg PG, Szachniewicz J, van der Meer P, Vinereanu D, Zieroth S, Brueckmann M, Sumin M, Bhatt DL, Butler J. Effect of Empagliflozin on Heart Failure Outcomes After Acute Myocardial Infarction: Insights From the EMPACT-MI Trial. Circulation. 2024 May 21;149(21):1627-1638. doi: 10.1161/CIRCULATIONAHA.124.069217. Epub 2024 Apr 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2019-001037-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1245-0202
Identifier Type: -
Identifier Source: org_study_id
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