A Study to Test the Effect of Empagliflozin in Patients Who Are in Hospital for Acute Heart Failure
NCT ID: NCT04157751
Last Updated: 2022-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
530 participants
INTERVENTIONAL
2020-05-18
2021-06-02
Brief Summary
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Participants are in the study for about 3 months. At the beginning, participants are still in hospital. Later, they visit the hospital about 3 times and get 1 phone call. 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. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. It is used to treat type 2 diabetes.
During the study, the doctors check whether participants have additional heart failure events like needing to go to the hospital again because of heart failure. The participants answer questions about how their heart failure affects their life. We then compare the results between the empagliflozin and placebo groups. 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
DOUBLE
Study Groups
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Empagliflozin
Empagliflozin
Film-coated tablet
Placebo
Placebo to Empagliflozin
Film-coated tablet
Interventions
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Empagliflozin
Film-coated tablet
Placebo to Empagliflozin
Film-coated tablet
Eligibility Criteria
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Inclusion Criteria
* Evidence of left ventricular ejection fraction (LVEF, either reduced or preserved EF) as per local reading preferably measured during current hospitalisation or in the 12 months prior to randomisation
* Patients must be randomised after at least 24 hours and no later than 5 days after admission, as early as possible after stabilization and while still in hospital
* Patients must fulfil the following stabilisation criteria (while in the hospital):
* SBP ≥100mm Hg and no symptoms of hypotension in the preceding 6 hours,
* no increase in i.v. diuretic dose for 6 hours prior to randomisation,
* no i.v. vasodilators including nitrates within the last 6 hours prior to randomisation
* no i.v. inotropic drugs for 24 hours prior to randomisation.
* Elevated NT-proBNP ≥ 1600pg/mL or BNP ≥400 pg/mL according to the local lab, for patients without atrial fibrillation (AF); or elevated NT-proBNP ≥ 2400pg/mL or BNP ≥600 pg/mL for patients with AF, measured during the current hospitalization or in the 72 hours prior to hospital admission,. For patients treated with an angiotensin receptor neprilysin inhibitor (ARNI) in the previous 4 weeks prior to randomisation, only NT-proBNP values should be used
* HF episode leading to hospitalisation must have been treated with a minimum single dose of 40 mg of i.v. furosemide (or equivalent i.v. loop diuretic defined as 20 mg of torasemide or 1 mg of bumetanide)
Exclusion Criteria
* Current hospitalisation for acute heart failure primarily triggered by pulmonary embolism, cerebrovascular accident, or acute myocardial infarction (AMI)
* Current hospitalisation for acute heart failure not caused primarily by intravascular volume overload;
* Below interventions in the past 30 days prior to randomisation or planned during the study:
* Major cardiac surgery, or TAVI (Transcatheter Aortic Valve Implantation), or PCI, or Mitraclip
* All other surgeries that are considered major according to investigator judgement
* Implantation of cardiac resynchronisation therapy (CRT) device
* cardiac mechanical support implantation
* Carotid artery disease revascularisation (stent or surgery)
* Acute coronary syndrome / myocardial infarction, stroke or transient ischemic attack (TIA) in the past 90 days prior to randomisation
* Heart transplant recipient, or listed for heart transplant with expectation to receive a transplant during the course of this trial (according to investigator judgement), or planned for palliative care for HF, or currently using left ventricular assist device (LVAD) or intra-aortic balloon pump (IABP) or any other type of mechanical circulatory support, or patients on mechanical ventilation, or patients with planned inotropic support in an outpatient setting
* Haemodynamically significant (severe) uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study (note: secondary mitral regurgitation or tricuspid regurgitation due to dilated cardiomyopathy is not excluded unless planned for surgery or intervention during the course of the study)
* Impaired renal function, defined as eGFR \< 20 mL/min/1.73 m2 as measured during hospitalization (latest local lab measurement before randomisation) or requiring dialysis
* Type 1 Diabetes Mellitus (T1DM)
* History of ketoacidosis, including diabetic ketoacidosis (DKA)
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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University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California Irvine
Orange, California, United States
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Cardiology Associates Research Co.
Daytona Beach, Florida, United States
University of Florida Health Jacksonville
Jacksonville, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Methodist Medical Center
Peoria, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
United Hospital
Saint Paul, Minnesota, United States
University Of Mississippi Medical Center
Jackson, Mississippi, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Cardiovascular Associates of the Delaware Valley
Elmer, New Jersey, United States
Jefferson Washington Township Hospital
Washington Township, New Jersey, United States
Erie County Medical Center
Buffalo, New York, United States
The DeMatteis Center for Cardiac Research and Education
Greenvale, New York, United States
Stony Brook Medicine
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
North Carolina Heart and Vascular
Raleigh, North Carolina, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
South Oklahoma Heart Research Group
Oklahoma City, Oklahoma, United States
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Pharmatex Research
Amarillo, Texas, United States
Center for Advanced Cardiac Care - Heart Failure Clinic
Plano, Texas, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Aalst - HOSP Onze-Lieve-Vrouw
Aalst, , Belgium
Brussels - UNIV UZ Brussel
Brussels, , Belgium
AZ Sint-Blasius
Dendermonde, , Belgium
Ziekenhuis Oost-Limburg - Campus Sint-Jan
Genk, , Belgium
UZ Leuven
Leuven, , Belgium
Liège - HOSP CHR de la Citadelle
Liège, , Belgium
UNIV Ambroise Paré
Mons, , Belgium
Royal Jubilee Hospital
Victoria, British Columbia, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Beijing Chao-Yang Hospital
Beijing, , China
Beijing AnZhen Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
West China Hospital
Chengdu, , China
First Affiliated Hospital of Xi'an JiaoTong University
Xi'an, , China
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, , China
University Hospital Brno
Brno, , Czechia
Univ.Hosp U Svate Anny, I.Internal Clinic-Cardiology,Brno
Brno, , Czechia
University Hospital Motol
Prague, , Czechia
District Hospital, Tabor
Tábor, , Czechia
Aalborg Universitetsshospital
Aalborg, , Denmark
Frederiksberg Hospital
Frederiksberg, , Denmark
Herlev and Gentofte Hospital
Herlev, , Denmark
Hvidovre Hospital
Hvidovre, , Denmark
Viborg Regionhospital
Viborg, , Denmark
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Bremer Institut für Herz- und Kreislaufforschung (BIHKF) am Klinikum Links der Weser
Bremen, , Germany
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, , Germany
Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH
Freiburg im Breisgau, , Germany
Universitätsklinikum Gießen und Marburg GmbH
Giessen, , Germany
Universitätsklinikum Jena
Jena, , Germany
Asklepios Klinik Langen-Seligenstadt GmbH
Langen, , Germany
Klinikum Leverkusen gGmbH, Leverkusen
Leverkusen, , Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, , Germany
Universitätsklinikum Würzburg AÖR
Würzburg, , Germany
Semmelweis University
Budapest, , Hungary
University Debrecen Hospital
Debrecen, , Hungary
University of Pecs
Pécs, , Hungary
Csongrad Country Dr Bugyi Istvan Hosp.
Szentes, , Hungary
Fejer County Saint George University Teaching Hospital
Székesfehérvár, , Hungary
ASST degli Spedali Civili di Brescia
Brescia, , Italy
Università degli Studi "Magna Grecia" - Campus "S. Venuta"
Catanzaro, , Italy
Ospedale della Val di Chiana Santa Margherita
Cortona, , Italy
Az.Osp. Universitaria "Ospedali Riuniti"
Foggia, , Italy
Centro Cardiologico Monzino-IRCCS
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Osp. Guglielmo da Saliceto AUSL di Piacenza
Piacenza, , Italy
IRCCS San Raffaele
Roma, , Italy
AO Città della Salute e della
Torino, , Italy
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, , Italy
Japan Community Health Care Organization Kyushu Hospital
Fukuoka, Kitakyushu, , Japan
Mito Medical Center
Ibaraki, Higashiibaraki-gun, , Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, , Japan
Shinshu University Hospital
Nagano, Matsumoto, , Japan
The Sakakibara Heart Institute of Okayama
Okayama, Okayama, , Japan
Osaka University Hospital
Osaka, Suita, , Japan
Kawaguchi Cardiovascular and Respiratory Hospital
Saitama, Kawaguchi, , Japan
Saitama Sekishikai Hospital
Saitama, Sayama, , Japan
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, , Japan
Jeroen Bosch Ziekenhuis-Hertogenbosch
's-Hertogenbosch, , Netherlands
Gelre Ziekenhuizen Apeldoorn
Apeldoorn, , Netherlands
TREANT Zorggroep
Emmen, , Netherlands
Groene Hart ziekenhuis
Gouda, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Sint Jansdal Ziekenhuis
Harderwijk, , Netherlands
Alrijne Leiderdorp
Leiderdorp, , Netherlands
Bravis ziekenhuis, locatie Roosendaal
Roosendaal, , Netherlands
HagaZiekenhuis
The Hague, , Netherlands
Diakonessenhuis Utrecht
Utrecht, , Netherlands
Helse Førde HF, Førde Sentralsjukehus
Førde, , Norway
Sykehuset Innlandet HF, Avd. Lillehammer
Lillehammer, , Norway
Akershus Universitetssykehus HF
Lørenskog, , Norway
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, , Norway
Universitetssykehuset Nord-Norge, Tromsø
Tromsø, , Norway
Saint Wincenty a Paulo Hosp., Cardiology Dept., Gdynia
Gdynia, , Poland
Card.Cli.Mil.Med.Ac.Uni.Cli.Hosp. Cent.Vetera.Hosp.Lodz
Lodz, , Poland
Cent.Clin.Hosp.Med.Univ.Lodz,Electrocard
Lodz, , Poland
Provincial Specialist M. Kopernik Hospital
Lodz, , Poland
Hospital Universitario Virgen de la Arrixaca
El Palmar, , Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, , Spain
Hospital Puerta de Hierro
Majadahonda, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Hospital Moises Broggi
Sant Joan Despí, , Spain
Hospital Nuestra Señora de Valme
Seville, , Spain
Hospital Clínico de Valencia
Valencia, , Spain
Sahlgrenska US, Göteborg
Gothenburg, , Sweden
Sahlgrenska Universitetssjukhuset, Östra
Gothenburg, , Sweden
Countries
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References
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Jongs N, Gasparyan SB, Frison L, Schloemer P, Brinker M, Little DJ, Heerspink HJL. Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point. J Am Soc Nephrol. 2025 Jun 17. doi: 10.1681/ASN.0000000766. Online ahead of print. No abstract available.
Ferreira JP, Blatchford JP, Teerlink JR, Kosiborod MN, Angermann CE, Biegus J, Collins SP, Tromp J, Nassif ME, Psotka MA, Comin-Colet J, Mentz RJ, Brueckmann M, Nordaby M, Ponikowski P, Voors AA. Mineralocorticoid receptor antagonist use and the effects of empagliflozin on clinical outcomes in patients admitted for acute heart failure: Findings from EMPULSE. Eur J Heart Fail. 2023 Oct;25(10):1797-1805. doi: 10.1002/ejhf.2982. Epub 2023 Aug 22.
Kosiborod MN, Angermann CE, Collins SP, Teerlink JR, Ponikowski P, Biegus J, Comin-Colet J, Ferreira JP, Mentz RJ, Nassif ME, Psotka MA, Tromp J, Brueckmann M, Blatchford JP, Salsali A, Voors AA. Effects of Empagliflozin on Symptoms, Physical Limitations, and Quality of Life in Patients Hospitalized for Acute Heart Failure: Results From the EMPULSE Trial. Circulation. 2022 Jul 26;146(4):279-288. doi: 10.1161/CIRCULATIONAHA.122.059725. Epub 2022 Apr 4.
Voors AA, Angermann CE, Teerlink JR, Collins SP, Kosiborod M, Biegus J, Ferreira JP, Nassif ME, Psotka MA, Tromp J, Borleffs CJW, Ma C, Comin-Colet J, Fu M, Janssens SP, Kiss RG, Mentz RJ, Sakata Y, Schirmer H, Schou M, Schulze PC, Spinarova L, Volterrani M, Wranicz JK, Zeymer U, Zieroth S, Brueckmann M, Blatchford JP, Salsali A, Ponikowski P. The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial. Nat Med. 2022 Mar;28(3):568-574. doi: 10.1038/s41591-021-01659-1. Epub 2022 Feb 28.
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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2019-002946-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1245-0204
Identifier Type: -
Identifier Source: org_study_id
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