TY - JOUR
T1 - Impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction-The EMMY trial
AU - EMMY study group
AU - Tripolt, Norbert J
AU - Kolesnik, Ewald
AU - Pferschy, Peter N
AU - Verheyen, Nicolas
AU - Ablasser, Klemens
AU - Sailer, Sandra
AU - Alber, Hannes
AU - Berger, Rudolf
AU - Kaulfersch, Carl
AU - Leitner, Katharina
AU - Lichtenauer, Michael
AU - Mader, Arthur
AU - Moertl, Deddo
AU - Oulhaj, Abderrahim
AU - Reiter, Christian
AU - Rieder, Thomas
AU - Saely, Christoph H
AU - Siller-Matula, Jolanta
AU - Weidinger, Franz
AU - Zechner, Peter M
AU - von Lewinski, Dirk
AU - Sourij, Harald
N1 - Funding Information:
The authors are grateful to all participants for their time and effort. We would also like to thank Prof/Dr Martin Clodi and Dr Michael Resl for their support and input in the early phases of the trial. Funding: The EMMY study is funded by an unrestricted Investigator Initiated Trial Grant from Boehringer Ingelheim. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the manuscript, and its final contents. Competing interests: HS received unrestricted research grants from Boehringer Ingelheim, Astra Zeneca, MSD, NovoNordisk, Sanofi-aventis, Kapsch and SAP. HS is on the speakers’ bureau of Amgen, Astra Zeneca, Boehringer Ingelheim, MSD, NovoNordisk, Sanofi-Aventis. DvL received unrestricted research grants from Boehringer Ingelheim, and Novartis. DvL is on the speakers’ bureau of Abiomed, Astra Zeneca, Bayer, Boehringer Ingelheim, NovoNordisk, Orion, Pfizer, Sanofi and Sanova. DvL is advisor for Bayer. CS reports personal fees and non-financial support from Boehringer Ingelheim, personal fees and non-financial support from Astra Zeneca, personal fees and non-financial support from MSD, outside the submitted work. HA reports personal fees from Boehringer Ingelheim, outside the submitted work. JSM reports personal fees from Daaichy, Astra Zeneca, Bayer, Roche, outside the submitted work. All other authors have nothing to declare.
Publisher Copyright:
© 2019 Elsevier Inc.
PY - 2020/3
Y1 - 2020/3
N2 - BACKGROUND: Sodium glucose cotransporter 2 (SGLT2) inhibitors are established antidiabetic drugs with proven cardiovascular benefit. Although growing evidence suggests beneficial effects on myocardial remodeling, fluid balance and cardiac function, the impact of empagliflozin initiated early after acute myocardial infarction (AMI) has not been investigated yet. Therefore, the impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction (EMMY) trial was designed to investigate the efficacy and safety of empagliflozin in diabetic and non-diabetic patients after severe AMI.METHODS: Within a multicenter, randomized, double-blind, placebo-controlled, phase 3b trial we will enroll patients with AMI and characteristics suggestive of severe myocardial necrosis are randomized in a 1:1 ratio to empagliflozin (10 mg once daily) or matching placebo. The primary endpoint is the impact of empagliflozin on changes in NT-proBNP within 6 months after AMI. Secondary endpoints include changes in echocardiographic parameters, levels of ketone body concentrations, HbA1c levels and body weight, respectively. Hospitalization rate due to heart failure or other causes, the duration of hospital stay and all-cause mortality will be assessed as exploratory secondary endpoints.DISCUSSION: The EMMY trial will test empagliflozin in patients with AMI regardless of their diabetic status. The EMMY trial may therefore underpin the concept of SGLT2 inhibition to improve cardiac remodeling, pre-and afterload reduction and cardiac metabolism regardless of its antidiabetic effects. Results will provide the rationale for the conduct of a cardiovascular outcome trial to test the effect of empagliflozin in patients with AMI.
AB - BACKGROUND: Sodium glucose cotransporter 2 (SGLT2) inhibitors are established antidiabetic drugs with proven cardiovascular benefit. Although growing evidence suggests beneficial effects on myocardial remodeling, fluid balance and cardiac function, the impact of empagliflozin initiated early after acute myocardial infarction (AMI) has not been investigated yet. Therefore, the impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction (EMMY) trial was designed to investigate the efficacy and safety of empagliflozin in diabetic and non-diabetic patients after severe AMI.METHODS: Within a multicenter, randomized, double-blind, placebo-controlled, phase 3b trial we will enroll patients with AMI and characteristics suggestive of severe myocardial necrosis are randomized in a 1:1 ratio to empagliflozin (10 mg once daily) or matching placebo. The primary endpoint is the impact of empagliflozin on changes in NT-proBNP within 6 months after AMI. Secondary endpoints include changes in echocardiographic parameters, levels of ketone body concentrations, HbA1c levels and body weight, respectively. Hospitalization rate due to heart failure or other causes, the duration of hospital stay and all-cause mortality will be assessed as exploratory secondary endpoints.DISCUSSION: The EMMY trial will test empagliflozin in patients with AMI regardless of their diabetic status. The EMMY trial may therefore underpin the concept of SGLT2 inhibition to improve cardiac remodeling, pre-and afterload reduction and cardiac metabolism regardless of its antidiabetic effects. Results will provide the rationale for the conduct of a cardiovascular outcome trial to test the effect of empagliflozin in patients with AMI.
KW - Benzhydryl Compounds/therapeutic use
KW - Diabetes Mellitus, Type 2/complications
KW - Double-Blind Method
KW - Echocardiography
KW - Glucosides/therapeutic use
KW - Glycated Hemoglobin A/metabolism
KW - Heart Failure/diagnostic imaging
KW - Hospitalization
KW - Humans
KW - Ketone Bodies/metabolism
KW - Length of Stay
KW - Mortality
KW - Myocardial Infarction/complications
KW - Natriuretic Peptide, Brain/metabolism
KW - Peptide Fragments/metabolism
KW - Sodium-Glucose Transporter 2 Inhibitors/therapeutic use
U2 - 10.1016/j.ahj.2019.12.004
DO - 10.1016/j.ahj.2019.12.004
M3 - Journal article
C2 - 31901799
SN - 0002-8703
VL - 221
SP - 39
EP - 47
JO - American Heart Journal
JF - American Heart Journal
ER -