TY - JOUR
T1 - Impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction—The EMMY trial
T2 - Empagliflozin after Myocardial Infarction
AU - on behalf of the 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 - 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.
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U2 - 10.1016/j.ahj.2019.12.004
DO - 10.1016/j.ahj.2019.12.004
M3 - Article
C2 - 31901799
AN - SCOPUS:85077311121
SN - 0002-8703
VL - 221
SP - 39
EP - 47
JO - American Heart Journal
JF - American Heart Journal
ER -