Placebo-Controlled, Double-Blind Study of Empagliflozin (EMPA) and Implantable Cardioverter-Defibrillator (EMPA-ICD) in
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Placebo-Controlled, Double-Blind Study of Empagliflozin (EMPA) and Implantable Cardioverter-Defibrillator (EMPAICD) in Patients with Type 2 Diabetes (T2DM): Rationale and Design Shinya Fujiki . Kenichi Iijima . Masaaki Okabe . Shinichi Niwano . Kenichi Tsujita . Shigeto Naito . Kenji Ando . Kengo Kusano . Ritsushi Kato . Junichi Nitta . Tetsuji Miura . Takeshi Mitsuhashi . Kazuomi Kario . Yusuke Kondo . Masaki Ieda . Nobuhisa Hagiwara . Toyoaki Murohara . Kazuyoshi Takahashi . Hirofumi Tomita . Yasuchika Takeishi . Toshihisa Anzai . Wataru Shimizu . Masafumi Watanabe . Yoshihiro Morino . Takeshi Kato . Hiroshi Tada . Yoshihisa Nakagawa . Masafumi Yano . Koji Maemura . Takeshi Kimura . Hisako Yoshida . Keiko Ota . Takahiro Tanaka . Nobutaka Kitamura . Koichi Node . Yoshifusa Aizawa . Ippei Shimizu . Daisuke Izumi . Kazuyuki Ozaki . Tohru Minamino
on behalf of the EMPA-ICD investigators
Received: April 9, 2020 / Accepted: September 3, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: Type 2 diabetes (T2DM) is associated with cardiovascular death, including sudden cardiac death due to arrhythmias. Patients with an implantable cardioverter-
Digital Features This article is published with digital features to facilitate understanding of the article. To view digital features for this article go to https://doi.org/ 10.6084/m9.figshare.12827783. Ihe EMPA-ICD investigators are listed in acknowledgements.
Electronic Supplementary Material The online version of this article (https://doi.org/10.1007/s13300020-00924-9) contains supplementary material, which is available to authorized users. S. Fujiki K. Iijima I. Shimizu D. Izumi K. Ozaki T. Minamino (&) Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan e-mail: [email protected] M. Okabe Y. Aizawa Department of Cardiology, Tachikawa General Hospital, Nagaoka, Niigata, Japan
defibrillator (ICD) are also at high risk of developing a clinically significant ventricular arrhythmia. It has been reported that sodium–glucose cotransporter 2 (SGLT2) inhibitors can reduce cardiovascular deaths; however, the physiological mechanisms of this remain unclear. It is, however, well known that SGLT2 inhibitors increase blood ketone bodies, which have been suggested to have sympathosuppressive effects. Empagliflozin (EMPA) is an SGLT2 inhibitor. The current clinical trial titled ‘‘Placebo-controlled, double-blind study of empagliflozin (EMPA) and implantable cardioverter-defibrillator (EMPA-ICD) in patients with type 2 diabetes (T2DM)’’ was designed to investigate the antiarrhythmic effects of EMPA.
S. Niwano Cardiovascular Medicine, Kitasato University, Sagamihara, Kanagawa, Japan K. Tsujita Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan
Diabetes Ther
Methods: The EMPA-ICD study is a prospective, multicenter, placebo-controlled, double-blind, randomized, investigator-initiated clinical trial currently in
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