Norbert J Tripolt1, Ewald Kolesnik2, Peter N Pferschy1, Nicolas Verheyen2, Klemens Ablasser2, Sandra Sailer2, Hannes Alber3, Rudolf Berger4, Carl Kaulfersch3, Katharina Leitner3, Michael Lichtenauer5, Arthur Mader6, Deddo Moertl7, Abderrahim Oulhaj8, Christian Reiter9, Thomas Rieder10, Christoph H Saely6, Jolanta Siller-Matula11, Franz Weidinger12, Peter M Zechner13, Dirk von Lewinski14, Harald Sourij1. 1. Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Diabetology, Graz, Austria. 2. Medical University of Graz, Department of Internal Medicine, Division of Cardiology, Graz, Austria. 3. Klinikum Klagenfurt, Department of Cardiology, Klagenfurt am Wörthersee, Austria. 4. Hospital Eisenstadt, Department of Internal Medicine, Eisenstadt, Austria. 5. Paracelsus Medical University Salzburg, Department of Internal Medicine II, Division of Cardiology and Internal Intensive Care Medicine, Salzburg, Austria. 6. Vorarlberg Institute for Vascular Investigation and Treatment (VIVIT), Feldkirch, Austria. 7. University Hospital St. Pölten, Department of Internal Medicine III, St.Pölten, St.Pölten, Austria. 8. College of Medicine and Health Sciences, United Arab Emirates University, P.O.Box 17666, Al-Ain, United Arab Emirates. 9. Kepleruniklinikum Linz, Department of Cardiology and Intensive Care Medicine, Linz, Austria. 10. Kardinal Schwarzenberg'sches Krankenhaus Schwarzach, Department of Medicine, Schwarzach, Austria. 11. Medical University of Vienna, Department of Cardiology, Vienna, Austria. 12. Krankenanstalt Rudolfstiftung, 2(nd) Medical Department with Cardiology and Intensive Care Medicine, Vienna, Austria. 13. Hospital Graz II Site West, Department of Cardiology and Intensive Care Medicine, Graz, Austria. 14. Medical University of Graz, Department of Internal Medicine, Division of Cardiology, Graz, Austria. Electronic address: dirk.von-lewinski@medunigraz.at.
Abstract
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.
RCT Entities:
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-diabeticpatients 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.
Authors: Ewald Kolesnik; Daniel Scherr; Ursula Rohrer; Martin Benedikt; Martin Manninger; Harald Sourij; Dirk von Lewinski Journal: Int J Mol Sci Date: 2022-01-31 Impact factor: 5.923
Authors: Gloria M Gager; Georg Gelbenegger; Bernd Jilma; Dirk von Lewinski; Harald Sourij; Ceren Eyileten; Krzysztof Filipiak; Marek Postula; Jolanta M Siller-Matula Journal: Front Cardiovasc Med Date: 2021-07-14