Kubota Yoshiaki, Yamamoto Takeshi, Tara Shuhei, Tokita Yukichi, Yodogawa Kenji, Iwasaki Yuki, Takano Hitoshi, Tsukada Yayoi, Asai Kuniya, Miyamoto Masaaki, Miyauchi Yasushi, Kodani Eitaro, Sato Naoki, Tanabe Jun, Shimizu Wataru
Department of Cardiovascular Medicine, Nippon Medical School Hospital, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.
Department of Cardiovascular Medicine, Nippon Medical School Chiba Hokusoh Hospital, 1715, Kamagari, Inzai, Chiba, 270-1694, Japan.
Diabetes Ther. 2018 Oct;9(5):2107-2116. doi: 10.1007/s13300-018-0480-7. Epub 2018 Aug 10.
Protection from lethal ventricular arrhythmias leading to sudden cardiac death is one of the most important problems after myocardial infarction. Cardiac sympathetic hyperactivity is related to poor prognosis and fatal arrhythmias and can be non-invasively assessed with heart rate variability, heart rate turbulence, T-wave alternans, late potentials, and I-meta-iodobenzylguanide (I-MIBG) scintigraphy. Sodium glucose cotransporter 2 (SGLT2) inhibitors potentially reduce sympathetic nervous system activity that is augmented in part due to the stimulatory effect of hyperglycemia. The EMBODY trial is designed to determine whether the suppression of cardiac sympathetic activity induced by the SGLT2 inhibitor is accompanied by protection against adverse cardiovascular outcomes.
The EMBODY trial is a prospective, multicenter, randomized, double-blind, placebo-controlled trial in patients with acute MI and type 2 diabetes in Japan. A total of 98 patients will be randomized (1:1) to receive once-daily placebo or empagliflozin, an SGLT2 inhibitor, 10 mg. The primary end point is the change from baseline to 24 weeks in heart rate variability. Secondary end points include the change from baseline for other sudden cardiac death surrogate-markers such as heart rate turbulence, T-wave alternans, late potentials, and I-MIBG scintigraphy imaging. Adverse effects will be evaluated throughout the trial period.
The EMBODY trial will evaluate the potential cardioprotective effect of empagliflozin and will provide additional important new data regarding its preventative effects on sudden cardiac death.
Unique Trial Number, UMIN000030158 ( https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000034442 ).
Nippon Boehringer Ingelheim and Eli Lilly and Company.
预防导致心源性猝死的致命性室性心律失常是心肌梗死后最重要的问题之一。心脏交感神经功能亢进与不良预后和致命性心律失常相关，可通过心率变异性、心率震荡、T波电交替、晚电位和碘-间位碘代苄胍（I-MIBG）闪烁显像进行无创评估。钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂可能会降低部分因高血糖刺激作用而增强的交感神经系统活性。EMBODY试验旨在确定SGLT2抑制剂诱导的心脏交感神经活性抑制是否伴随着对不良心血管结局的保护作用。
EMBODY试验是一项针对日本急性心肌梗死和2型糖尿病患者的前瞻性、多中心、随机、双盲、安慰剂对照试验。总共98名患者将被随机分组（1:1），分别每日一次接受安慰剂或10毫克SGLT2抑制剂恩格列净治疗。主要终点是心率变异性从基线到24周的变化。次要终点包括其他心源性猝死替代标志物从基线的变化，如心率震荡、T波电交替、晚电位和I-MIBG闪烁显像。在整个试验期间将评估不良反应。
EMBODY试验将评估恩格列净的潜在心脏保护作用，并将提供有关其对心源性猝死预防作用的重要新数据。
唯一试验编号，UMIN000030158（https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000034442）。
日本勃林格殷格翰公司和礼来公司。
