Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial
Abstract Background Protection from lethal ventricular arrhythmias leading to sudden cardiac death (SCD) is a crucial challenge after acute myocardial infarction (AMI). Cardiac sympathetic and parasympathetic activity can be noninvasively assessed using heart rate variability (HRV) and heart rate tu...
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BMC
2020-09-01
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Online Access: | http://link.springer.com/article/10.1186/s12933-020-01127-z |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Wataru Shimizu Yoshiaki Kubota Yu Hoshika Kosuke Mozawa Shuhei Tara Yukichi Tokita Kenji Yodogawa Yu-ki Iwasaki Takeshi Yamamoto Hitoshi Takano Yayoi Tsukada Kuniya Asai Masaaki Miyamoto Yasushi Miyauchi Eitaro Kodani Masahiro Ishikawa Mitsunori Maruyama Michio Ogano Jun Tanabe EMBODY trial investigators |
spellingShingle |
Wataru Shimizu Yoshiaki Kubota Yu Hoshika Kosuke Mozawa Shuhei Tara Yukichi Tokita Kenji Yodogawa Yu-ki Iwasaki Takeshi Yamamoto Hitoshi Takano Yayoi Tsukada Kuniya Asai Masaaki Miyamoto Yasushi Miyauchi Eitaro Kodani Masahiro Ishikawa Mitsunori Maruyama Michio Ogano Jun Tanabe EMBODY trial investigators Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial Cardiovascular Diabetology Acute Myocardial Infarction Heart rate variability Heart rate turbulence Sodium–glucose cotransporter 2 inhibitor Sudden cardiac death Randomized Controlled Trial |
author_facet |
Wataru Shimizu Yoshiaki Kubota Yu Hoshika Kosuke Mozawa Shuhei Tara Yukichi Tokita Kenji Yodogawa Yu-ki Iwasaki Takeshi Yamamoto Hitoshi Takano Yayoi Tsukada Kuniya Asai Masaaki Miyamoto Yasushi Miyauchi Eitaro Kodani Masahiro Ishikawa Mitsunori Maruyama Michio Ogano Jun Tanabe EMBODY trial investigators |
author_sort |
Wataru Shimizu |
title |
Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial |
title_short |
Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial |
title_full |
Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial |
title_fullStr |
Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial |
title_full_unstemmed |
Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial |
title_sort |
effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the embody trial |
publisher |
BMC |
series |
Cardiovascular Diabetology |
issn |
1475-2840 |
publishDate |
2020-09-01 |
description |
Abstract Background Protection from lethal ventricular arrhythmias leading to sudden cardiac death (SCD) is a crucial challenge after acute myocardial infarction (AMI). Cardiac sympathetic and parasympathetic activity can be noninvasively assessed using heart rate variability (HRV) and heart rate turbulence (HRT). The EMBODY trial was designed to determine whether the Sodium–glucose cotransporter 2 (SGLT2) inhibitor improves cardiac nerve activity. Methods This prospective, multicenter, randomized, double-blind, placebo-controlled trial included patients with AMI and type 2 diabetes mellitus (T2DM) in Japan; 105 patients were randomized (1:1) to receive once-daily 10-mg empagliflozin or placebo. The primary endpoints were changes in HRV, e.g., the standard deviation of all 5-min mean normal RR intervals (SDANN) and the low-frequency–to–high-frequency (LF/HF) ratio from baseline to 24 weeks. Secondary endpoints were changes in other sudden cardiac death (SCD) surrogate markers such as HRT. Results Overall, 96 patients were included (46, empagliflozin group; 50, placebo group). The changes in SDANN were + 11.6 and + 9.1 ms in the empagliflozin (P = 0.02) and placebo groups (P = 0.06), respectively. Change in LF/HF ratio was – 0.57 and – 0.17 in the empagliflozin (P = 0.01) and placebo groups (P = 0.43), respectively. Significant improvement was noted in HRT only in the empagliflozin group (P = 0.01). Whereas intergroup comparison on HRV and HRT showed no significant difference between the empagliflozin and placebo groups. Compared with the placebo group, the empagliflozin group showed significant decreases in body weight, systolic blood pressure, and uric acid. In the empagliflozin group, no adverse events were observed. Conclusions This is the first randomized clinical data to evaluate the effect of empagliflozin on cardiac sympathetic and parasympathetic activity in patients with T2DM and AMI. Early SGLT2 inhibitor administration in AMI patients with T2DM might be effective in improving cardiac nerve activity without any adverse events. Trial Registration: The EMBODY trial was registered by the UMIN in November 2017 (ID: 000030158). UMIN000030158; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034442 . |
topic |
Acute Myocardial Infarction Heart rate variability Heart rate turbulence Sodium–glucose cotransporter 2 inhibitor Sudden cardiac death Randomized Controlled Trial |
url |
http://link.springer.com/article/10.1186/s12933-020-01127-z |
work_keys_str_mv |
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doaj-d993e2883d2d4205b15f072f7a4d2d682020-11-25T03:22:48ZengBMCCardiovascular Diabetology1475-28402020-09-0119111210.1186/s12933-020-01127-zEffects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trialWataru Shimizu0Yoshiaki Kubota1Yu Hoshika2Kosuke Mozawa3Shuhei Tara4Yukichi Tokita5Kenji Yodogawa6Yu-ki Iwasaki7Takeshi Yamamoto8Hitoshi Takano9Yayoi Tsukada10Kuniya Asai11Masaaki Miyamoto12Yasushi Miyauchi13Eitaro Kodani14Masahiro Ishikawa15Mitsunori Maruyama16Michio Ogano17Jun Tanabe18EMBODY trial investigatorsDepartment of Cardiovascular Medicine, Nippon Medical SchoolDepartment of Cardiovascular Medicine, Nippon Medical SchoolDepartment of Cardiovascular Medicine, Nippon Medical SchoolDepartment of Cardiovascular Medicine, Nippon Medical SchoolDepartment of Cardiovascular Medicine, Nippon Medical SchoolDepartment of Cardiovascular Medicine, Nippon Medical SchoolDepartment of Cardiovascular Medicine, Nippon Medical SchoolDepartment of Cardiovascular Medicine, Nippon Medical SchoolDepartment of Cardiovascular Medicine, Nippon Medical SchoolDepartment of Cardiovascular Medicine, Nippon Medical SchoolDepartment of Cardiovascular Medicine, Nippon Medical SchoolDepartment of Cardiovascular Medicine, Nippon Medical SchoolDepartment of Cardiovascular Medicine, Nippon Medical SchoolDepartment of Cardiovascular Medicine, Nippon Medical School Chiba Hokuso HospitalDepartment of Cardiovascular Medicine, Nippon Medical School Tama Nagayama HospitalDepartment of Cardiovascular Medicine, Nippon MEDICAL School Musashi Kosugi HospitalDepartment of Cardiovascular Medicine, Nippon MEDICAL School Musashi Kosugi HospitalDepartment of Cardiovascular Medicine, Shizuoka Medical CenterDepartment of Cardiovascular Medicine, Shizuoka Medical CenterAbstract Background Protection from lethal ventricular arrhythmias leading to sudden cardiac death (SCD) is a crucial challenge after acute myocardial infarction (AMI). Cardiac sympathetic and parasympathetic activity can be noninvasively assessed using heart rate variability (HRV) and heart rate turbulence (HRT). The EMBODY trial was designed to determine whether the Sodium–glucose cotransporter 2 (SGLT2) inhibitor improves cardiac nerve activity. Methods This prospective, multicenter, randomized, double-blind, placebo-controlled trial included patients with AMI and type 2 diabetes mellitus (T2DM) in Japan; 105 patients were randomized (1:1) to receive once-daily 10-mg empagliflozin or placebo. The primary endpoints were changes in HRV, e.g., the standard deviation of all 5-min mean normal RR intervals (SDANN) and the low-frequency–to–high-frequency (LF/HF) ratio from baseline to 24 weeks. Secondary endpoints were changes in other sudden cardiac death (SCD) surrogate markers such as HRT. Results Overall, 96 patients were included (46, empagliflozin group; 50, placebo group). The changes in SDANN were + 11.6 and + 9.1 ms in the empagliflozin (P = 0.02) and placebo groups (P = 0.06), respectively. Change in LF/HF ratio was – 0.57 and – 0.17 in the empagliflozin (P = 0.01) and placebo groups (P = 0.43), respectively. Significant improvement was noted in HRT only in the empagliflozin group (P = 0.01). Whereas intergroup comparison on HRV and HRT showed no significant difference between the empagliflozin and placebo groups. Compared with the placebo group, the empagliflozin group showed significant decreases in body weight, systolic blood pressure, and uric acid. In the empagliflozin group, no adverse events were observed. Conclusions This is the first randomized clinical data to evaluate the effect of empagliflozin on cardiac sympathetic and parasympathetic activity in patients with T2DM and AMI. Early SGLT2 inhibitor administration in AMI patients with T2DM might be effective in improving cardiac nerve activity without any adverse events. Trial Registration: The EMBODY trial was registered by the UMIN in November 2017 (ID: 000030158). UMIN000030158; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034442 .http://link.springer.com/article/10.1186/s12933-020-01127-zAcute Myocardial InfarctionHeart rate variabilityHeart rate turbulenceSodium–glucose cotransporter 2 inhibitorSudden cardiac deathRandomized Controlled Trial |