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)
Primary Purpose
Myocardial Infarction
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Empagliflozin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- Of full age of consent (according to local legislation, at least ≥ 18 years) at screening.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- 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.
- 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.
High risk of HF, defined as EITHER
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
- 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.
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:
- Diagnosis of chronic Heart Failure (HF) prior to index MI.
- Systolic blood pressure < 90 mmHg at randomisation.
- Cardiogenic shock or use of i.v. inotropes in last 24 hours before randomisation.
- Coronary Artery Bypass Grafting planned at time of randomisation.
- Current diagnosis of Takotsubo cardiomyopathy.
- Any current severe (stenotic or regurgitant) valvular heart disease.
- eGFR < 20 ml/min/1.73m2 (using CKD-EPI formula based on most recent creatinine from local lab during index hospitalisation) or on dialysis.
- Type I diabetes mellitus. Further exclusion criteria apply.
Sites / Locations
- Advanced Cardiovascular LLC
- Grandview Medical Center
- Heart Center Research, LLC
- Mercy Gilbert Medical Center
- Arkansas Cardiology, PA
- Comprehensive Cardiovascular Medical Group
- Valley Clinical Trials, Inc.
- Cardiovascular Innovation and Research Center
- University of California Los Angeles
- InvivoCure
- Valley Clinical Trials, Inc.
- Valley Clinical Trials, Inc.
- Kaiser Permanente
- San Diego Cardiac Center
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Interventional Cardiology Medical Group
- George Washington University Medical Faculty Associates
- Clearwater Cardiovascular Consultants
- Integrative Research Associates
- University of Florida Health Jacksonville
- Cardiology Partners Clinical Research Institute
- Charlotte Heart Group Research Center
- Grady Memorial Hospital
- Cardiovascular Consultants of South Georgia, LLC
- Atlanta Heart Specialists, LLC
- Advanced Heart Care, LLC, Medicoricum, LLC
- Midwest Cardiovascular Research and Education Foundation
- Cardiovascular Research of Northwest Indiana, LLC
- Reid Physician Associates
- Midwest Heart and Vascular Specialists
- University of Kentucky Medical Center
- University of Louisville
- Eastern Maine Medical Center
- Cardiovascular Specialists of Central Maryland
- Shady Grove Adventist Hospital
- Healthy Heart Cardiology
- Western Michigan University
- Mid Michigan Medical Center
- Michigan Heart, PC
- Minneapolis Heart Institute Foundation
- Cardiology Associates Research, LLC
- Missouri Cardiovascular Specialists, LLP
- University of Missouri Health System
- North Kansas City Hospital
- Gateway Cardiology, PC
- St. Louis Heart and Vascular, P.C.
- Holy Name Medical Center
- AtlantiCare
- The Heart House
- SJH Cardiology Associates
- Stony Brook University Hospital
- Asheville Cardiology Associates
- The University of North Carolina at Chapel Hill
- Duke University Medical Center
- Moses H. Cone Memorial Hospital
- Medication Management, LLC
- North Carolina Heart and Vascular
- Trinity Health Center Medical Arts
- Aultman Hospital
- Cincinnati VA Medical Center
- Kettering Medical Center
- Oklahoma Heart Hospital Research Foundation, Incorporated
- South Oklahoma Heart Research Group
- Capital Area Research, LLC
- Penn Presbyterian Medical Center
- Guthrie Medical Group PC
- Upstate Cardiology, PA
- Carolina Heart Specialists, LLC
- Monument Health
- Centennial Heart Cardiovascular Consultants, LLC
- Parkway Cardiology Associates
- Cardiovascular Research of Knoxville
- Texas Health Presbyterian Hospital Allen
- Amarillo Heart Clinical Research Institute, Incorporated
- Pharmatex Research
- Dallas VA Medical Center
- Baylor Scott and White Health
- South Texas Cardiovascular Consultants
- Revival Research Institute, LLC.
- Cardiovascular Associates of East Texas, PA
- Carient Heart and Vascular
- Riverside Regional Medical Center
- Tidewater Physicians Multispecialty Group
- Sentara Hospitals
- Roanoke Heart Institute PLC
- Instituto Cardiovascular de Buenos Aires
- Fundacion Sanatorio Güemes
- Hospital Italiano de Córdoba
- Sanatorio Allende
- Centro Medico Luquez
- Hospital Privado Centro Medico de Cordoba
- Clinica Privada del Prado
- Centro de Investigacion Clinica Coronel Suarez
- Instituto de Cardiología de Corrientes
- Fundación Favaloro para la Docencia e Investigación Medica
- Sanatorio Modelo de Quilmes
- Instituto Cardiovascular de Rosario
- Sanatorio Delta
- Sanatorio Parque
- Corporacion Medica de Gral. San Martin S.A.
- Centro Privado de Cardiología
- Clinica U.O.M.
- Sanatorio Diagnóstico
- Hospital "Dr. José Maria Cullen"
- Clinica Privada Fusavim SRL
- Concord Repatriation General Hospital
- South Western Sydney Local Health District
- Royal North Shore Hospital
- Westmead Hospital
- The Prince Charles Hospital
- Royal Brisbane and Women's Hospital
- Gold Coast University Hospital
- Alfred Hospital
- JMF Clinica Do Coracao LTDA
- Hospital Santa Isabel
- Hospital Madre Teresa
- Hospital do Coracao do Brasil
- Hospital Angelina Caron
- Centro Especializado em Cardiol Loema Instituto de Pesq Clin
- IPECC - Instituto de Pesquisa Clínica de Campinas
- Hospital de Messejana Dr. Carlos Alberto Studart Gomes
- HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
- Hospital Regional Hans Dieter Schmidt
- Santa Casa de Misericórdia de Marília
- Hospital São Vicente de Paulo
- Hospital Sao Lucas da PUCRS
- Instituto de Cardiologia Rio Grande do Sul
- Hospital Nossa Senhora da Conceição
- Hospital Agamenon Magalhaes
- Fundacao de apoio ao ensino e assitencia HCFMRP
- Hospital Copa D'or
- Instituto de Ensino E Pesquisa Do Hospital Da Bahia
- Hospital de Base - Fac Med de Sao Jose do Rio Preto
- Hospital Samaritano
- Hospital Sao Luiz Jabaquara
- Hospital Sao Luiz Morumbi
- Hospital das Clínicas de Sao Paulo - INCOR
- CEMEC - Centro Multidisciplinar de Estudos Clínicos
- Santa Casa de Votuporanga
- Multiprofile Hospital For Active Treatment Pulse AD
- Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" AD
- Multiprofile Hospital for Active Treatment AD Haskovo
- Multiprofile Hospital For Active Treatment - Pazardzhik AD
- Specialized Hospital for Active Treatment Sv. Georgi - Pernik
- Multiprofile Hospital for Active Treatment Heart and Brain EAD
- SHAT in Cardiology EAD, Pleven
- Medical Center Medconsult Pleven LTD
- Hospital MHAT Plovdiv, AD
- National Heart Hospital, Sofia
- City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia
- University Multiprofile Hospital for Active Treatement "Alexandrovska" EAD
- UMHAT "Tsaritsa Yoannalsul"
- Medical Military Academy MHAT Sofia
- Multiprofile Hospital MHATEM 'Pirogov', Sofia
- MHAT Sv.Anna, Clinic of Internal Diseases, Sofia
- Hospital Trakia Park
- Heritage Medical Research Clinic
- Royal Alexandra Hospital
- University of Alberta Hospital (University of Alberta)
- Royal Inland Hospital
- Surrey Memorial Hospital
- Vancouver General Hospital
- Victoria Heart Institute Foundation
- St. Boniface Hospital
- GA Research Associates Ltd.
- QEII Health Sciences Centre
- William Osler Health Centre
- Queen's University
- One Heart Care Ventures
- Southlake Regional Health Centre
- Peterborough Regional Health Centre
- Heart Health Institute
- Women's College Hospital
- Montreal Heart Institute
- Centre Hospitalier de l'Universite de Montreal (CHUM)
- Montreal General Hospital - McGill University Health Centre
- McGill University Health Centre (MUHC)
- IUCPQ (Laval University)
- CIUSSS de l Estrie-CHUS
- CSSS du Sud de Lanaudiere - Hopital Pierre-Le Gardeur
- CIUSSS de la Mauricie-et-du-Centre-du-Quebec
- Prairie Vascular Research Inc.
- Oakville Trafalgar Memorial Hospital
- Beijing Chao-Yang Hospital
- Chinese PLA General Hospital
- China-Japan Friendship Hospital
- Peking University First Hospital
- Beijing Luhe Hospital Capital Medical University
- Changsha Central Hospital
- Xiangya Hospital, Central South University
- Guangdong Provincial People's Hospital
- The First Affiliated Hospital of Harbin Medical University
- Hainan General Hospital
- Shulan(Hanghzhou) Hospital
- Zhejiang Hospital
- Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
- The Second Affiliated Hospital of Lanzhou Medical University
- Nanjing Drum Tower Hospital
- Zhongshan Hospital Fudan University
- People's Hospital of Liaoning Province
- Peking University Shenzhen Hospital
- Renmin Hospital of Wuhan University
- Aalborg Universitetsshospital
- Aarhus University Hospital
- Rigshospitalet
- Frederiksberg Hospital
- Herlev and Gentofte Hospital
- Slagelse Sygehus
- HOP Sud Francilien
- HOP CHU de Grenoble
- CHRU Lille
- Hospital de Saint Joseph et Saint Luc
- HOP Bichat
- CHU Rouen
- HOP Trousseau
- HOP Brabois
- SLK-Kliniken Heilbronn GmbH
- Kerckhoff-Klinik, Bad Nauheim
- Charité - Universitätsmedizin Berlin
- Universitätsklinikum Bonn AöR
- Bremer Institut für Herz- und Kreislaufforschung (BIHKF) am Klinikum Links der Weser
- Klinikum Coburg gGmbH
- St. Johannes Hospital Dortmund
- Städtisches Klinikum Dresden
- Universitätsklinikum Frankfurt
- Klinikum Frankfurt Höchst GmbH
- Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH
- Asklepios Kliniken GmbH & Co. KGaA
- Medizinische Hochschule Hannover
- Ambulantes Herzzentrum Kassel
- Universitätsklinikum Leipzig
- Katholisches Klinikum Mainz
- Clemenshospital
- Kardiologische Praxis Papenburg
- Universitätsklinikum Regensburg
- Lausmed Kft. Outpatient Unit of Internal Medicine
- Buda Hospital of the Hospitaller Order of Saint John of God
- Semmelweis University
- St. Imre Hospital, Budapest
- Semmelweis University
- Magyar Honvedseg Egeszsegugyi Kozpont
- Jahn Ferenc Del-Pest Hospital
- University Debrecen Hospital
- Csongrad Megyei Eu. Ellato Kozp. Hodmezovasarhely-Mako
- Somogy County Kaposi Mor Teaching Hospital
- Bacs-Kiskun Megyei Onkormanyzat Hospital
- Pest Megyei Flor Ferenc Hospital
- University of Szeged
- Fejer County Saint George University Teaching Hospital
- Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet
- Zala County Hospital, Zalaegerszeg
- Kamalnayan Bajaj Hospital
- Sri Jayadeva Institute of Cardiovascular Sciences & Research
- Narayana Institute of Cardiac Sciences
- KLES Dr.Prabhakar Kore Hospital and Medical Research Centre
- Madras Medical Mission,
- Eternal Heart Care Centre & Research Institute Pvt. Ltd.
- KEM Hospital and Seth G S Medical College
- Sion Hospital (Lokmanya Tilak Municipal Hospital)
- Government Medical College & Hospital
- GB Pant Institute of Post Graduate Medical Education and Research
- Max Superspeciality Hospital
- Sir Gangaram Hospital
- Sahyadri Speciality Hospital
- Haemek Medical Center
- Assuta Medical Center
- Barzilai Medical Center
- Soroka Univ. Medical Center
- Assaf Harofe Medical Center
- Hillel Yaffe Medical Center, Hadera
- Rambam Medical Center
- Bnei Zion Medical Center, Haifa
- Lady Davis Carmel Medical Center
- Hadassah Medical Center, Ein-Karem
- Shaare Zedek Medical Center, Jerusalem 91031
- Hadassah Medical Center, Ein-Karem
- Meir Medical Center
- West.Galilee Med.Cent.Naharia
- Rabin Medical Center Beilinson
- Rabin Medical Center Beilinson
- The Chaim Sheba Medical Center Tel HaShomer
- Kaplan Medical Center
- Ziv Medical Center
- Sourasky Medical Center
- Baruch Padeh Medical Center
- Kasugai Municipal Hospital
- Toyota Memorial Hospital
- Chibanishi General Hospital
- Seikeikai New Tokyo Heart Clinic
- Saiseikai Fukuoka General Hospital
- Gifu Prefectural General Medical Center
- Ogaki Municipal Hospital
- Hiroshima General Hospital
- Hiroshima Prefectural Hospital
- Hyogo Brain and Heart Center
- Ibaraki Prefectural Central Hospital
- Tsuchiura Kyodo General Hospital
- Ishikawa Prefectural Central Hospital
- Juntendo University Shizuoka Hospital
- Tokai University Hospital
- Sagamihara Kyodo Hospital
- Yokohama City University Medical Center
- Fukuoka Tokushukai Hospital
- Saiseikai Kumamoto Hospital
- Japanese Red Cross Kumamoto Hospital
- Kusatsu General Hospital
- Miyazaki Medical Association Hospital
- Nagano Chuo Hospital
- Osaka Police Hospital
- Kagawa Prefectural Central Hospital
- Tokushima Prefectural Central Hospital
- St. Luke's International Hospital
- Tokyo Bay Urayasu Ichikawa Medical Center
- Showa University Fujigaoka Hospital
- Bucheon Sejong Hospital
- Pusan National Univ. Hosp
- Chungbuk National University Hospital
- Chungnam National University Hospital
- Chonnam National University Hospital
- Seoul National University Bundang Hospital
- Yonsei University Wonju Severance Christian Hospital
- Noordwest Ziekenhuisgroep
- Meander Medisch Centrum
- Amsterdam UMC Locatie VUMC
- Onze Lieve Vrouwe Gasthuis
- Rijnstate Hospital
- Amphia Ziekenhuis
- IJsselland Ziekenhuis
- Catharina Ziekenhuis
- Medisch Spectrum Twente
- Admiraal de Ruyter Ziekenhuis
- Universitair Medisch Centrum Groningen
- Spaarne Ziekenhuis
- Zuyderland Medisch Centrum
- Jeroen Bosch Ziekenhuis-Hertogenbosch
- Tergooi Ziekenhuis
- Vasculair Onderzoek Centrum
- Medisch Centrum Leeuwarden
- Leids Universitair Medisch Centrum (LUMC)
- Alrijne Ziekenhuis
- Ziekenhuis Rivierenland
- Tweesteden Ziekenhuis, locatie Tilburg
- Isala Zwolle
- American Heart of Poland
- Univ. Clinic Hosp, Bialystok
- American Heart of Poland Sp. z o.o.
- American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre
- American Heart of Poland Sp. z o.o.
- NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog.
- Silesian Medical University in Katowice
- American Heart of Poland Sp. z o.o.
- University Hospital in Krakow
- The John Paul II Hosp.,Dept.of Coronary Heart Disease,Krakow
- Podhalanski Special.Hosp,Intern.Med&Cardiology Dept,Nowy Tag
- Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego
- Medicome Limited Liability Company
- Independent Public Healthcare, Dept. of Cardiology, Pulawy
- American Heart of Poland Sp. z o.o.
- American Heart of Poland Sp. z o.o.
- Dr Alfred Sokołowski Specialist Hospital
- Central Hospital of Medical Academy, Warsaw
- Instytut Kardiologii, Warszawa
- Jan Mikulicz-Radecki UnivClinic Hosp,Cardiology Dept,Wroclaw
- 4. Military Clinical Hospital with Polyclinic SP ZOZ
- Emergency Clinical County Hospital, Baia Mare
- Spitalul Clinic De Urgenta "Prof. Dr. Agrippa Ionescu"
- Spitalul Judetean de Urgenta Braila
- Spitalul Clinic Judetean de Urgenta Brasov
- Military Central Clinical Emergency Hospital
- Elias Emergency Hospital, Bucharest
- Prof.C.C.Iliescu Hospital, National Institute of Cardiology
- Emergency Clinical Hospital "Bagdasar-Arseni"
- Emergency University Hospital, Bucharest
- Heart Institute "Niculae Stancioiu", Cluj Napoca
- Clincal Reabilitation Hospital, Cluj Napoca
- Spitalul Clinic Judetean, Craiova
- Cardiovascular Diseases Institute "Prof. Georgescu", Iasi
- SC Cardiomed SRL, Iasi
- SC Endodigest SRL
- Sal Med Srl
- Emergency County Clinical Hospital, Sibiu
- Centrul Medical Cardiomed
- Country Clinical Emergency Hospital, Targu-Mures
- Cardiology and Cardiovascular Rehabilitation Clinic
- First City Clinical Hospital named after E. E. Volosevich
- Regional Clinical Hospital, Kirov
- Regional Clinical Hospital No.1 n.a. Ochapovskiy, Krasnodar
- State Healthcare Institution Clinical Hosp. No. 51, Moscow
- Reg.Clin.Hosp.n.a.Semashko
- Penza Regional Clinical Hospital named after N.N.Burdenko
- Republic Kareliya Republican Hosp. named after V.A. Baranov
- GUZ Ryazanskiy Regional Clin. Cardiology Dispensary, Ryazan
- Samara Regional Clinical Cardiology Clinic, Day Hosp. Dept.
- Saratov State Med.Univ.n.a.Razumovskogo
- Saratov Regional Cardiac Center
- Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine
- Medical Academy named after I. Mechnikov, St. Petersburg
- Komi Republican Cardiological Dispensary
- Regional clinical hospital, Tver
- Tyumen Cardiology Center, Dept.of Cardiac Arrhythmia
- State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr
- Institute for Cardiovascular diseases Dedinje
- University Clinical Center of Serbia
- Clinical Hospital Center Dr. Dragisa Misovic
- Clinical Medical Center Zvezdara, Belgrade
- University Clinical Center of Kragujevac
- General Hospital Leskovac
- Institute for Treatment and Rehabilitation, Niska Banja
- University Clinical Center Nis
- General Hospital Pancevo
- Institute of Cardiovascular Diseases
- General Hospital Sremska Mitrovica
- General Hospital Subotica, Internal Medicine
- Health Center Uzice
- Health Centre Zajecar
- General Hospital - Djordje Joanovic
- Hospital Germans Trias i Pujol
- University Hospital of Bellvitge
- Hospital Universitario 12 de Octubre
- Hospital Universitari Joan XXIII
- Complejo Hospitalario Universitario de Vigo
- Cherkasy Regional Cardiological Center
- City Joint Emergency Hospital, Dnepropetrovsk
- Ivano-Frankivsk City Central Clinical Hospital
- Clinical Medical Diagnostic Center Simedgroup
- L.T. Malaya Institute of Therapy AMS of Ukraine
- Reg.Clin.Hosp.Non-Commercial Enterprise
- CI of Healthcare Kharkiv CCH #8, Kharkiv
- Khmelnytskyi Regional Hospital
- Kiev City Clinical Hospital No. 5
- SI NSC M.D. Strazhesko Institute Cardiology of NAMSU, Kyiv
- City Clinical Hospital No. 1, Kiev
- Kiev Emergency Care Hospital
- Lutsk City Clinical Hospital
- Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
- Odesa Regional Clinical Hospital
- Regional Clinical Hospital, Ternopil
- Transcarpathian Regional Clinical Center
- Zhytomyr Regional Clinical Hospital, Dept. Endocrinology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Empagliflozin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Composite of time to first heart failure hospitalisation or all-cause mortality
Secondary Outcome Measures
Total number of HHF or all-cause mortality
Total number of non-elective Cardiovascular (CV) hospitalisations or all-cause mortality
Total number of non-elective all-cause hospitalisations or all-cause mortality
Total number of hospitalisations for MI or all-cause mortality
Time to CV mortality
Full Information
NCT ID
NCT04509674
First Posted
August 10, 2020
Last Updated
September 22, 2023
Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT04509674
Brief Title
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)
Official Title
EMPACT-MI: A Streamlined, Multicentre, Randomised, Parallel Group, Double-blind Placebo-controlled Superiority Trial to Evaluate the Effect of EMPAgliflozin on Hospitalisation for Heart Failure and Mortality in Patients With aCuTe Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a study in adults who had a heart attack (myocardial infarction). The purpose of this study is to find out whether a medicine called empagliflozin helps to lower the chances of having to go to the hospital for heart failure and whether it lowers the chances of dying from cardiovascular disease.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Blinded investigator review of events in place of centralized adjudication.
Allocation
Randomized
Enrollment
6522 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Empagliflozin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Intervention Description
Empagliflozin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Composite of time to first heart failure hospitalisation or all-cause mortality
Time Frame
up to 26 months
Secondary Outcome Measure Information:
Title
Total number of HHF or all-cause mortality
Time Frame
up to 26 months
Title
Total number of non-elective Cardiovascular (CV) hospitalisations or all-cause mortality
Time Frame
up to 26 months
Title
Total number of non-elective all-cause hospitalisations or all-cause mortality
Time Frame
up to 26 months
Title
Total number of hospitalisations for MI or all-cause mortality
Time Frame
up to 26 months
Title
Time to CV mortality
Time Frame
up to 26 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Of full age of consent (according to local legislation, at least ≥ 18 years) at screening.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
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.
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.
High risk of HF, defined as EITHER
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
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.
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:
Diagnosis of chronic Heart Failure (HF) prior to index MI.
Systolic blood pressure < 90 mmHg at randomisation.
Cardiogenic shock or use of i.v. inotropes in last 24 hours before randomisation.
Coronary Artery Bypass Grafting planned at time of randomisation.
Current diagnosis of Takotsubo cardiomyopathy.
Any current severe (stenotic or regurgitant) valvular heart disease.
eGFR < 20 ml/min/1.73m2 (using CKD-EPI formula based on most recent creatinine from local lab during index hospitalisation) or on dialysis.
Type I diabetes mellitus. Further exclusion criteria apply.
Facility Information:
Facility Name
Advanced Cardiovascular LLC
City
Alexander City
State/Province
Alabama
ZIP/Postal Code
35010
Country
United States
Facility Name
Grandview Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Heart Center Research, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Mercy Gilbert Medical Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Arkansas Cardiology, PA
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Comprehensive Cardiovascular Medical Group
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Valley Clinical Trials, Inc.
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
Cardiovascular Innovation and Research Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
InvivoCure
City
Mission Hills
State/Province
California
ZIP/Postal Code
91346
Country
United States
Facility Name
Valley Clinical Trials, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Valley Clinical Trials, Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Kaiser Permanente
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
San Diego Cardiac Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Interventional Cardiology Medical Group
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
George Washington University Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Clearwater Cardiovascular Consultants
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Integrative Research Associates
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Facility Name
University of Florida Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Cardiology Partners Clinical Research Institute
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Charlotte Heart Group Research Center
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Cardiovascular Consultants of South Georgia, LLC
City
Thomasville
State/Province
Georgia
ZIP/Postal Code
31792
Country
United States
Facility Name
Atlanta Heart Specialists, LLC
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Facility Name
Advanced Heart Care, LLC, Medicoricum, LLC
City
Fairview Heights
State/Province
Illinois
ZIP/Postal Code
62208
Country
United States
Facility Name
Midwest Cardiovascular Research and Education Foundation
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
Cardiovascular Research of Northwest Indiana, LLC
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Reid Physician Associates
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
Midwest Heart and Vascular Specialists
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0200
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Cardiovascular Specialists of Central Maryland
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Shady Grove Adventist Hospital
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Healthy Heart Cardiology
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Western Michigan University
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Mid Michigan Medical Center
City
Midland
State/Province
Michigan
ZIP/Postal Code
48670
Country
United States
Facility Name
Michigan Heart, PC
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Cardiology Associates Research, LLC
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Missouri Cardiovascular Specialists, LLP
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
University of Missouri Health System
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
North Kansas City Hospital
City
North Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
Gateway Cardiology, PC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
St. Louis Heart and Vascular, P.C.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Holy Name Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
AtlantiCare
City
Pomona
State/Province
New Jersey
ZIP/Postal Code
08240
Country
United States
Facility Name
The Heart House
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
Facility Name
SJH Cardiology Associates
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Asheville Cardiology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Moses H. Cone Memorial Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Medication Management, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
North Carolina Heart and Vascular
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Trinity Health Center Medical Arts
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58701
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Cincinnati VA Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Oklahoma Heart Hospital Research Foundation, Incorporated
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
South Oklahoma Heart Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
Country
United States
Facility Name
Capital Area Research, LLC
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Guthrie Medical Group PC
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Upstate Cardiology, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Carolina Heart Specialists, LLC
City
Lancaster
State/Province
South Carolina
ZIP/Postal Code
29720
Country
United States
Facility Name
Monument Health
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Centennial Heart Cardiovascular Consultants, LLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Parkway Cardiology Associates
City
Oak Ridge
State/Province
Tennessee
ZIP/Postal Code
37830
Country
United States
Facility Name
Cardiovascular Research of Knoxville
City
Powell
State/Province
Tennessee
ZIP/Postal Code
37849
Country
United States
Facility Name
Texas Health Presbyterian Hospital Allen
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Facility Name
Amarillo Heart Clinical Research Institute, Incorporated
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Pharmatex Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79109
Country
United States
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Baylor Scott and White Health
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
South Texas Cardiovascular Consultants
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
Revival Research Institute, LLC.
City
Sherman
State/Province
Texas
ZIP/Postal Code
75092
Country
United States
Facility Name
Cardiovascular Associates of East Texas, PA
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Carient Heart and Vascular
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20109
Country
United States
Facility Name
Riverside Regional Medical Center
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
Facility Name
Tidewater Physicians Multispecialty Group
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Sentara Hospitals
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Roanoke Heart Institute PLC
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Instituto Cardiovascular de Buenos Aires
City
Belgrano
ZIP/Postal Code
C1428ART
Country
Argentina
Facility Name
Fundacion Sanatorio Güemes
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1180 AAX
Country
Argentina
Facility Name
Hospital Italiano de Córdoba
City
Cordoba
ZIP/Postal Code
X5000
Country
Argentina
Facility Name
Sanatorio Allende
City
Cordoba
ZIP/Postal Code
X5000
Country
Argentina
Facility Name
Centro Medico Luquez
City
Cordoba
ZIP/Postal Code
X5006CBI
Country
Argentina
Facility Name
Hospital Privado Centro Medico de Cordoba
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Clinica Privada del Prado
City
Cordoba
ZIP/Postal Code
X5020AAA
Country
Argentina
Facility Name
Centro de Investigacion Clinica Coronel Suarez
City
Coronel Suarez
ZIP/Postal Code
B7540GHD
Country
Argentina
Facility Name
Instituto de Cardiología de Corrientes
City
Corrientes
ZIP/Postal Code
3400
Country
Argentina
Facility Name
Fundación Favaloro para la Docencia e Investigación Medica
City
Monserrat
ZIP/Postal Code
C1093AAS
Country
Argentina
Facility Name
Sanatorio Modelo de Quilmes
City
Quilmes
ZIP/Postal Code
B1878GEG
Country
Argentina
Facility Name
Instituto Cardiovascular de Rosario
City
Rosario
ZIP/Postal Code
S2000
Country
Argentina
Facility Name
Sanatorio Delta
City
Rosario
ZIP/Postal Code
S2000
Country
Argentina
Facility Name
Sanatorio Parque
City
Rosario
ZIP/Postal Code
S2000
Country
Argentina
Facility Name
Corporacion Medica de Gral. San Martin S.A.
City
San Martin
ZIP/Postal Code
B1650CSP
Country
Argentina
Facility Name
Centro Privado de Cardiología
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Clinica U.O.M.
City
San Nicolas
ZIP/Postal Code
2900
Country
Argentina
Facility Name
Sanatorio Diagnóstico
City
Santa Fe
ZIP/Postal Code
3081
Country
Argentina
Facility Name
Hospital "Dr. José Maria Cullen"
City
Santa Fé
ZIP/Postal Code
S3000EOZ
Country
Argentina
Facility Name
Clinica Privada Fusavim SRL
City
Villa Maria
ZIP/Postal Code
5900
Country
Argentina
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
South Western Sydney Local Health District
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
JMF Clinica Do Coracao LTDA
City
Aracaju - SE
ZIP/Postal Code
49055-530
Country
Brazil
Facility Name
Hospital Santa Isabel
City
Balneario Camboriu
ZIP/Postal Code
88331-085
Country
Brazil
Facility Name
Hospital Madre Teresa
City
Belo Horizonte
ZIP/Postal Code
30441-070
Country
Brazil
Facility Name
Hospital do Coracao do Brasil
City
Brasilia
ZIP/Postal Code
70390 700
Country
Brazil
Facility Name
Hospital Angelina Caron
City
Campina Grande do Sul
ZIP/Postal Code
83430-000
Country
Brazil
Facility Name
Centro Especializado em Cardiol Loema Instituto de Pesq Clin
City
Campinas
ZIP/Postal Code
13010-001
Country
Brazil
Facility Name
IPECC - Instituto de Pesquisa Clínica de Campinas
City
Campinas
ZIP/Postal Code
13060-080
Country
Brazil
Facility Name
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
City
Fortaleza
ZIP/Postal Code
60840-285
Country
Brazil
Facility Name
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
City
Goiania
ZIP/Postal Code
74605-020
Country
Brazil
Facility Name
Hospital Regional Hans Dieter Schmidt
City
Joinville
ZIP/Postal Code
89227-680
Country
Brazil
Facility Name
Santa Casa de Misericórdia de Marília
City
Marília
ZIP/Postal Code
17515-000
Country
Brazil
Facility Name
Hospital São Vicente de Paulo
City
Passo Fundo
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Hospital Sao Lucas da PUCRS
City
Porto Alegre
ZIP/Postal Code
01046 010
Country
Brazil
Facility Name
Instituto de Cardiologia Rio Grande do Sul
City
Porto Alegre
ZIP/Postal Code
90620-001
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceição
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Hospital Agamenon Magalhaes
City
Recife
ZIP/Postal Code
52051-380
Country
Brazil
Facility Name
Fundacao de apoio ao ensino e assitencia HCFMRP
City
Ribeirao Preto
ZIP/Postal Code
14051-140
Country
Brazil
Facility Name
Hospital Copa D'or
City
Rio de Janeiro
ZIP/Postal Code
22031-011
Country
Brazil
Facility Name
Instituto de Ensino E Pesquisa Do Hospital Da Bahia
City
Salvador
ZIP/Postal Code
41810-011
Country
Brazil
Facility Name
Hospital de Base - Fac Med de Sao Jose do Rio Preto
City
Sao Jose do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Hospital Samaritano
City
Sao Paulo
ZIP/Postal Code
01333-030
Country
Brazil
Facility Name
Hospital Sao Luiz Jabaquara
City
Sao Paulo
ZIP/Postal Code
04321-120
Country
Brazil
Facility Name
Hospital Sao Luiz Morumbi
City
Sao Paulo
ZIP/Postal Code
04544-000
Country
Brazil
Facility Name
Hospital das Clínicas de Sao Paulo - INCOR
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
CEMEC - Centro Multidisciplinar de Estudos Clínicos
City
São Bernardo do Campo
ZIP/Postal Code
09715-090
Country
Brazil
Facility Name
Santa Casa de Votuporanga
City
Votuporanga
ZIP/Postal Code
15500-003
Country
Brazil
Facility Name
Multiprofile Hospital For Active Treatment Pulse AD
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" AD
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment AD Haskovo
City
Haskovo
ZIP/Postal Code
6304
Country
Bulgaria
Facility Name
Multiprofile Hospital For Active Treatment - Pazardzhik AD
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment Sv. Georgi - Pernik
City
Pernik
ZIP/Postal Code
2300
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Heart and Brain EAD
City
Pleven
ZIP/Postal Code
5804
Country
Bulgaria
Facility Name
SHAT in Cardiology EAD, Pleven
City
Pleven
ZIP/Postal Code
5804
Country
Bulgaria
Facility Name
Medical Center Medconsult Pleven LTD
City
Pleven
ZIP/Postal Code
5808
Country
Bulgaria
Facility Name
Hospital MHAT Plovdiv, AD
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
National Heart Hospital, Sofia
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatement "Alexandrovska" EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT "Tsaritsa Yoannalsul"
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Medical Military Academy MHAT Sofia
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Multiprofile Hospital MHATEM 'Pirogov', Sofia
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
MHAT Sv.Anna, Clinic of Internal Diseases, Sofia
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Facility Name
Hospital Trakia Park
City
Stara Zagora
ZIP/Postal Code
6004
Country
Bulgaria
Facility Name
Heritage Medical Research Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
University of Alberta Hospital (University of Alberta)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Royal Inland Hospital
City
Kamloops
State/Province
British Columbia
ZIP/Postal Code
V2C 2T1
Country
Canada
Facility Name
Surrey Memorial Hospital
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Victoria Heart Institute Foundation
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1B2
Country
Canada
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
GA Research Associates Ltd.
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1G 1A7
Country
Canada
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
William Osler Health Centre
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
One Heart Care Ventures
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 1M3
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P7
Country
Canada
Facility Name
Peterborough Regional Health Centre
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 7C6
Country
Canada
Facility Name
Heart Health Institute
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1B 4Z8
Country
Canada
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Montreal General Hospital - McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
McGill University Health Centre (MUHC)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
IUCPQ (Laval University)
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
CIUSSS de l Estrie-CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
CSSS du Sud de Lanaudiere - Hopital Pierre-Le Gardeur
City
Terrebonne (Lachenaie)
State/Province
Quebec
ZIP/Postal Code
J6V 2H2
Country
Canada
Facility Name
CIUSSS de la Mauricie-et-du-Centre-du-Quebec
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
Prairie Vascular Research Inc.
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4P 0W5
Country
Canada
Facility Name
Oakville Trafalgar Memorial Hospital
City
Oakville
ZIP/Postal Code
L6M 0L8
Country
Canada
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100022
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Luhe Hospital Capital Medical University
City
Beijing
ZIP/Postal Code
101100
Country
China
Facility Name
Changsha Central Hospital
City
Changsha
ZIP/Postal Code
410007
Country
China
Facility Name
Xiangya Hospital, Central South University
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
ZIP/Postal Code
510100
Country
China
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Haerbin
ZIP/Postal Code
150001
Country
China
Facility Name
Hainan General Hospital
City
Haikou
ZIP/Postal Code
570311
Country
China
Facility Name
Shulan(Hanghzhou) Hospital
City
Hangzhou
ZIP/Postal Code
310004
Country
China
Facility Name
Zhejiang Hospital
City
Hangzhou
ZIP/Postal Code
310013
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
The Second Affiliated Hospital of Lanzhou Medical University
City
Lanzhou
ZIP/Postal Code
730030
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
People's Hospital of Liaoning Province
City
Shenyang
ZIP/Postal Code
110016
Country
China
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
ZIP/Postal Code
518036
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
ZIP/Postal Code
430060
Country
China
Facility Name
Aalborg Universitetsshospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Frederiksberg Hospital
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Herlev and Gentofte Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Slagelse Sygehus
City
Slagelse
ZIP/Postal Code
4200
Country
Denmark
Facility Name
HOP Sud Francilien
City
Corbeil Essonnes
ZIP/Postal Code
91106
Country
France
Facility Name
HOP CHU de Grenoble
City
Grenoble Cedex 9
ZIP/Postal Code
38043
Country
France
Facility Name
CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hospital de Saint Joseph et Saint Luc
City
Lyon
ZIP/Postal Code
69007
Country
France
Facility Name
HOP Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
CHU Rouen
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
HOP Trousseau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
HOP Brabois
City
Vandoeuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
SLK-Kliniken Heilbronn GmbH
City
Bad Friedrichshall
ZIP/Postal Code
74177
Country
Germany
Facility Name
Kerckhoff-Klinik, Bad Nauheim
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Universitätsklinikum Bonn AöR
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Bremer Institut für Herz- und Kreislaufforschung (BIHKF) am Klinikum Links der Weser
City
Bremen
ZIP/Postal Code
28277
Country
Germany
Facility Name
Klinikum Coburg gGmbH
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
St. Johannes Hospital Dortmund
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Städtisches Klinikum Dresden
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Facility Name
Klinikum Frankfurt Höchst GmbH
City
Frankfurt/Main
ZIP/Postal Code
65929
Country
Germany
Facility Name
Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH
City
Freiburg I. Breisgau
ZIP/Postal Code
79106
Country
Germany
Facility Name
Asklepios Kliniken GmbH & Co. KGaA
City
Hamburg
ZIP/Postal Code
22307
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Ambulantes Herzzentrum Kassel
City
Kassel
ZIP/Postal Code
34121
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Katholisches Klinikum Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Clemenshospital
City
Münster
ZIP/Postal Code
48153
Country
Germany
Facility Name
Kardiologische Praxis Papenburg
City
Papenburg
ZIP/Postal Code
26871
Country
Germany
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Lausmed Kft. Outpatient Unit of Internal Medicine
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Buda Hospital of the Hospitaller Order of Saint John of God
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
St. Imre Hospital, Budapest
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Jahn Ferenc Del-Pest Hospital
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
University Debrecen Hospital
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Csongrad Megyei Eu. Ellato Kozp. Hodmezovasarhely-Mako
City
Hodmezovasarhely
ZIP/Postal Code
6800
Country
Hungary
Facility Name
Somogy County Kaposi Mor Teaching Hospital
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Bacs-Kiskun Megyei Onkormanyzat Hospital
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Hospital
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
University of Szeged
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Fejer County Saint George University Teaching Hospital
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Zala County Hospital, Zalaegerszeg
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Kamalnayan Bajaj Hospital
City
Aurangabad
ZIP/Postal Code
431 010
Country
India
Facility Name
Sri Jayadeva Institute of Cardiovascular Sciences & Research
City
Bangalore
ZIP/Postal Code
560069
Country
India
Facility Name
Narayana Institute of Cardiac Sciences
City
Bangalore
ZIP/Postal Code
560099
Country
India
Facility Name
KLES Dr.Prabhakar Kore Hospital and Medical Research Centre
City
Belagavi
ZIP/Postal Code
590010
Country
India
Facility Name
Madras Medical Mission,
City
Chennai
ZIP/Postal Code
600037
Country
India
Facility Name
Eternal Heart Care Centre & Research Institute Pvt. Ltd.
City
Jaipur
ZIP/Postal Code
302017
Country
India
Facility Name
KEM Hospital and Seth G S Medical College
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Sion Hospital (Lokmanya Tilak Municipal Hospital)
City
Mumbai
ZIP/Postal Code
400022
Country
India
Facility Name
Government Medical College & Hospital
City
Nagpur
ZIP/Postal Code
440009
Country
India
Facility Name
GB Pant Institute of Post Graduate Medical Education and Research
City
New Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
Max Superspeciality Hospital
City
New Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Sir Gangaram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Sahyadri Speciality Hospital
City
Pune
ZIP/Postal Code
411004
Country
India
Facility Name
Haemek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Assuta Medical Center
City
Ashdod
ZIP/Postal Code
77000
Country
Israel
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Soroka Univ. Medical Center
City
Beer Sheba
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Assaf Harofe Medical Center
City
Beer Yaacov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Hillel Yaffe Medical Center, Hadera
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Bnei Zion Medical Center, Haifa
City
Haifa
ZIP/Postal Code
33394
Country
Israel
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Hadassah Medical Center, Ein-Karem
City
Jerusalem
ZIP/Postal Code
91000
Country
Israel
Facility Name
Shaare Zedek Medical Center, Jerusalem 91031
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah Medical Center, Ein-Karem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir Medical Center
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
West.Galilee Med.Cent.Naharia
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Rabin Medical Center Beilinson
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Rabin Medical Center Beilinson
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
The Chaim Sheba Medical Center Tel HaShomer
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Ziv Medical Center
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Baruch Padeh Medical Center
City
Tiberias
ZIP/Postal Code
15208
Country
Israel
Facility Name
Kasugai Municipal Hospital
City
Aichi, Kasugai
ZIP/Postal Code
486-8510
Country
Japan
Facility Name
Toyota Memorial Hospital
City
Aichi, Toyota
ZIP/Postal Code
471-8513
Country
Japan
Facility Name
Chibanishi General Hospital
City
Chiba, Matsudo
ZIP/Postal Code
270-2251
Country
Japan
Facility Name
Seikeikai New Tokyo Heart Clinic
City
Chiba, Matsudo
ZIP/Postal Code
271-0077
Country
Japan
Facility Name
Saiseikai Fukuoka General Hospital
City
Fukuoka, Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
Facility Name
Gifu Prefectural General Medical Center
City
Gifu, Gifu
ZIP/Postal Code
500-8717
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Gifu, Ogaki
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Hiroshima General Hospital
City
Hatsukaichi
ZIP/Postal Code
738-8503
Country
Japan
Facility Name
Hiroshima Prefectural Hospital
City
Hiroshima, Hiroshima
ZIP/Postal Code
734-8530
Country
Japan
Facility Name
Hyogo Brain and Heart Center
City
Hyogo, Himeji
ZIP/Postal Code
670-0981
Country
Japan
Facility Name
Ibaraki Prefectural Central Hospital
City
Ibaraki, Kasama
ZIP/Postal Code
309-1793
Country
Japan
Facility Name
Tsuchiura Kyodo General Hospital
City
Ibaraki, Tsuchiura
ZIP/Postal Code
300-0028
Country
Japan
Facility Name
Ishikawa Prefectural Central Hospital
City
Ishikawa, Kanazawa
ZIP/Postal Code
920-8530
Country
Japan
Facility Name
Juntendo University Shizuoka Hospital
City
Izunokuni
ZIP/Postal Code
410-2295
Country
Japan
Facility Name
Tokai University Hospital
City
Kanagawa, Isehara
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Sagamihara Kyodo Hospital
City
Kanagawa, Sagamihara
ZIP/Postal Code
252-5188
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Kanagawa, Yokohama
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Fukuoka Tokushukai Hospital
City
Kasuga
ZIP/Postal Code
816-0864
Country
Japan
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto, Kumamoto
ZIP/Postal Code
861-4193
Country
Japan
Facility Name
Japanese Red Cross Kumamoto Hospital
City
Kumamoto, Kumamoto
ZIP/Postal Code
861-8520
Country
Japan
Facility Name
Kusatsu General Hospital
City
Kusatsu
ZIP/Postal Code
525-8585
Country
Japan
Facility Name
Miyazaki Medical Association Hospital
City
Miyazaki
ZIP/Postal Code
880-2102
Country
Japan
Facility Name
Nagano Chuo Hospital
City
Nagano, Nagano
ZIP/Postal Code
380-0814
Country
Japan
Facility Name
Osaka Police Hospital
City
Osaka, Osaka
ZIP/Postal Code
543-0035
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital
City
Takamatsu
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
Tokushima Prefectural Central Hospital
City
Tokushima
ZIP/Postal Code
770-0042
Country
Japan
Facility Name
St. Luke's International Hospital
City
Tokyo, Chuo-ku
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Tokyo Bay Urayasu Ichikawa Medical Center
City
Urayasu
ZIP/Postal Code
279-0001
Country
Japan
Facility Name
Showa University Fujigaoka Hospital
City
Yokohama
ZIP/Postal Code
227-8501
Country
Japan
Facility Name
Bucheon Sejong Hospital
City
Bucheon
ZIP/Postal Code
14754
Country
Korea, Republic of
Facility Name
Pusan National Univ. Hosp
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Cheongiu
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejoen
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Wonju-si
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Noordwest Ziekenhuisgroep
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Meander Medisch Centrum
City
Amersfoort
ZIP/Postal Code
3813 TZ
Country
Netherlands
Facility Name
Amsterdam UMC Locatie VUMC
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 HA
Country
Netherlands
Facility Name
Rijnstate Hospital
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
IJsselland Ziekenhuis
City
Capelle Aan Den Ijssel
ZIP/Postal Code
2906 ZC
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7513 ER
Country
Netherlands
Facility Name
Admiraal de Ruyter Ziekenhuis
City
Goes
ZIP/Postal Code
4462 RA
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Spaarne Ziekenhuis
City
Haarlem
ZIP/Postal Code
2035 RC
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Jeroen Bosch Ziekenhuis-Hertogenbosch
City
Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Tergooi Ziekenhuis
City
Hilversum
ZIP/Postal Code
1213 XZ
Country
Netherlands
Facility Name
Vasculair Onderzoek Centrum
City
Hoorn
ZIP/Postal Code
1624 NP
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum (LUMC)
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
Alrijne Ziekenhuis
City
Leiden
ZIP/Postal Code
2334 CK
Country
Netherlands
Facility Name
Ziekenhuis Rivierenland
City
Tiel
ZIP/Postal Code
4002 WP
Country
Netherlands
Facility Name
Tweesteden Ziekenhuis, locatie Tilburg
City
Tilburg
ZIP/Postal Code
5042 AD
Country
Netherlands
Facility Name
Isala Zwolle
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
American Heart of Poland
City
Belchatow
ZIP/Postal Code
97-400
Country
Poland
Facility Name
Univ. Clinic Hosp, Bialystok
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
American Heart of Poland Sp. z o.o.
City
Bielsko-Biala
ZIP/Postal Code
43-316
Country
Poland
Facility Name
American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre
City
Chorzow
ZIP/Postal Code
32-500
Country
Poland
Facility Name
American Heart of Poland Sp. z o.o.
City
Dabrowa Gornicza
ZIP/Postal Code
41-300
Country
Poland
Facility Name
NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog.
City
Gdynia
ZIP/Postal Code
81-423
Country
Poland
Facility Name
Silesian Medical University in Katowice
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Facility Name
American Heart of Poland Sp. z o.o.
City
Kedzierzyn-Kozle
ZIP/Postal Code
47-200
Country
Poland
Facility Name
University Hospital in Krakow
City
Krakow
ZIP/Postal Code
30-688
Country
Poland
Facility Name
The John Paul II Hosp.,Dept.of Coronary Heart Disease,Krakow
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Podhalanski Special.Hosp,Intern.Med&Cardiology Dept,Nowy Tag
City
Nowy Targ
ZIP/Postal Code
34-400
Country
Poland
Facility Name
Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego
City
Ostroleka
ZIP/Postal Code
07-410
Country
Poland
Facility Name
Medicome Limited Liability Company
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Independent Public Healthcare, Dept. of Cardiology, Pulawy
City
Pulawy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
American Heart of Poland Sp. z o.o.
City
Sztum
ZIP/Postal Code
82-400
Country
Poland
Facility Name
American Heart of Poland Sp. z o.o.
City
Tychy
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Dr Alfred Sokołowski Specialist Hospital
City
Walbrzych
ZIP/Postal Code
58-309
Country
Poland
Facility Name
Central Hospital of Medical Academy, Warsaw
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Instytut Kardiologii, Warszawa
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Jan Mikulicz-Radecki UnivClinic Hosp,Cardiology Dept,Wroclaw
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
4. Military Clinical Hospital with Polyclinic SP ZOZ
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
Facility Name
Emergency Clinical County Hospital, Baia Mare
City
Baia Mare
ZIP/Postal Code
430031
Country
Romania
Facility Name
Spitalul Clinic De Urgenta "Prof. Dr. Agrippa Ionescu"
City
Balotesti
ZIP/Postal Code
077016
Country
Romania
Facility Name
Spitalul Judetean de Urgenta Braila
City
Braila
ZIP/Postal Code
810325
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Brasov
City
Brasov
ZIP/Postal Code
500326
Country
Romania
Facility Name
Military Central Clinical Emergency Hospital
City
Bucharest
ZIP/Postal Code
010825
Country
Romania
Facility Name
Elias Emergency Hospital, Bucharest
City
Bucharest
ZIP/Postal Code
011461
Country
Romania
Facility Name
Prof.C.C.Iliescu Hospital, National Institute of Cardiology
City
Bucharest
ZIP/Postal Code
022322
Country
Romania
Facility Name
Emergency Clinical Hospital "Bagdasar-Arseni"
City
Bucharest
ZIP/Postal Code
041915
Country
Romania
Facility Name
Emergency University Hospital, Bucharest
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
Heart Institute "Niculae Stancioiu", Cluj Napoca
City
Cluj Napoca
ZIP/Postal Code
400001
Country
Romania
Facility Name
Clincal Reabilitation Hospital, Cluj Napoca
City
Cluj Napoca
ZIP/Postal Code
400347
Country
Romania
Facility Name
Spitalul Clinic Judetean, Craiova
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Cardiovascular Diseases Institute "Prof. Georgescu", Iasi
City
Iasi
ZIP/Postal Code
700503
Country
Romania
Facility Name
SC Cardiomed SRL, Iasi
City
Iasi
ZIP/Postal Code
700732
Country
Romania
Facility Name
SC Endodigest SRL
City
Oradea
ZIP/Postal Code
410151
Country
Romania
Facility Name
Sal Med Srl
City
Pitesti
ZIP/Postal Code
110437
Country
Romania
Facility Name
Emergency County Clinical Hospital, Sibiu
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Centrul Medical Cardiomed
City
Targu-Mures
ZIP/Postal Code
540124
Country
Romania
Facility Name
Country Clinical Emergency Hospital, Targu-Mures
City
Targu-Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Cardiology and Cardiovascular Rehabilitation Clinic
City
Timisoara
ZIP/Postal Code
300310
Country
Romania
Facility Name
First City Clinical Hospital named after E. E. Volosevich
City
Arkhangelsk
ZIP/Postal Code
163001
Country
Russian Federation
Facility Name
Regional Clinical Hospital, Kirov
City
Kirov
ZIP/Postal Code
610014
Country
Russian Federation
Facility Name
Regional Clinical Hospital No.1 n.a. Ochapovskiy, Krasnodar
City
Krasnodar
ZIP/Postal Code
350086
Country
Russian Federation
Facility Name
State Healthcare Institution Clinical Hosp. No. 51, Moscow
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
Reg.Clin.Hosp.n.a.Semashko
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Penza Regional Clinical Hospital named after N.N.Burdenko
City
Penza
ZIP/Postal Code
440026
Country
Russian Federation
Facility Name
Republic Kareliya Republican Hosp. named after V.A. Baranov
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
GUZ Ryazanskiy Regional Clin. Cardiology Dispensary, Ryazan
City
Ryazan
ZIP/Postal Code
390039
Country
Russian Federation
Facility Name
Samara Regional Clinical Cardiology Clinic, Day Hosp. Dept.
City
Samara
ZIP/Postal Code
443070
Country
Russian Federation
Facility Name
Saratov State Med.Univ.n.a.Razumovskogo
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Saratov Regional Cardiac Center
City
Saratov
ZIP/Postal Code
410039
Country
Russian Federation
Facility Name
Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine
City
St. Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Medical Academy named after I. Mechnikov, St. Petersburg
City
St. Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Komi Republican Cardiological Dispensary
City
Syktyvkar
ZIP/Postal Code
167981
Country
Russian Federation
Facility Name
Regional clinical hospital, Tver
City
Tver
ZIP/Postal Code
170036
Country
Russian Federation
Facility Name
Tyumen Cardiology Center, Dept.of Cardiac Arrhythmia
City
Tyumen
ZIP/Postal Code
625026
Country
Russian Federation
Facility Name
State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr
City
Volgograd
ZIP/Postal Code
400062
Country
Russian Federation
Facility Name
Institute for Cardiovascular diseases Dedinje
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Dr. Dragisa Misovic
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
Facility Name
Clinical Medical Center Zvezdara, Belgrade
City
Belgrade
ZIP/Postal Code
11050
Country
Serbia
Facility Name
University Clinical Center of Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
General Hospital Leskovac
City
Leskovac
ZIP/Postal Code
16000
Country
Serbia
Facility Name
Institute for Treatment and Rehabilitation, Niska Banja
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
University Clinical Center Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
General Hospital Pancevo
City
Pancevo
ZIP/Postal Code
26101
Country
Serbia
Facility Name
Institute of Cardiovascular Diseases
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
General Hospital Sremska Mitrovica
City
Sremska Mitrovica
ZIP/Postal Code
22000
Country
Serbia
Facility Name
General Hospital Subotica, Internal Medicine
City
Subotica
ZIP/Postal Code
24107
Country
Serbia
Facility Name
Health Center Uzice
City
Uzice
ZIP/Postal Code
31000
Country
Serbia
Facility Name
Health Centre Zajecar
City
Zajecar
ZIP/Postal Code
19000
Country
Serbia
Facility Name
General Hospital - Djordje Joanovic
City
Zrenjanin
ZIP/Postal Code
23101
Country
Serbia
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
University Hospital of Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitari Joan XXIII
City
Tarragona
ZIP/Postal Code
43005
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Vigo
City
Vigo
ZIP/Postal Code
36213
Country
Spain
Facility Name
Cherkasy Regional Cardiological Center
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
City Joint Emergency Hospital, Dnepropetrovsk
City
Dnepropetrovsk
ZIP/Postal Code
49006
Country
Ukraine
Facility Name
Ivano-Frankivsk City Central Clinical Hospital
City
Ivano-Frankivsk
ZIP/Postal Code
76005
Country
Ukraine
Facility Name
Clinical Medical Diagnostic Center Simedgroup
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
L.T. Malaya Institute of Therapy AMS of Ukraine
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Reg.Clin.Hosp.Non-Commercial Enterprise
City
Kharkiv
ZIP/Postal Code
61058
Country
Ukraine
Facility Name
CI of Healthcare Kharkiv CCH #8, Kharkiv
City
Kharkiv
ZIP/Postal Code
61176
Country
Ukraine
Facility Name
Khmelnytskyi Regional Hospital
City
Khmelnytskyi
ZIP/Postal Code
29007
Country
Ukraine
Facility Name
Kiev City Clinical Hospital No. 5
City
Kiev
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
SI NSC M.D. Strazhesko Institute Cardiology of NAMSU, Kyiv
City
Kiev
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
City Clinical Hospital No. 1, Kiev
City
Kiev
ZIP/Postal Code
2091
Country
Ukraine
Facility Name
Kiev Emergency Care Hospital
City
Kiev
ZIP/Postal Code
2166
Country
Ukraine
Facility Name
Lutsk City Clinical Hospital
City
Lutsk
ZIP/Postal Code
43024
Country
Ukraine
Facility Name
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
City
Lviv
ZIP/Postal Code
79015
Country
Ukraine
Facility Name
Odesa Regional Clinical Hospital
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Regional Clinical Hospital, Ternopil
City
Ternopil
ZIP/Postal Code
46001
Country
Ukraine
Facility Name
Transcarpathian Regional Clinical Center
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Zhytomyr Regional Clinical Hospital, Dept. Endocrinology
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
IPD Sharing Time Frame
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD Sharing Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
https://www.mystudywindow.com/
Description
Related Info
Learn more about this trial
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)
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