Effect of Empagliflozin Versus Placebo on Cardiac Sympathetic Activity in Acute Myocardial Infarction Patients with Type 2 Diabetes Mellitus: Rationale.
Effect of Empagliflozin Versus Placebo on Cardiac Sympathetic Activity in Acute Myocardial Infarction Patients with Type 2 Diabetes Mellitus: Rationale.
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DOI：
10.1007/s13300-018-0480-7
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发表时间：
2018-10
期刊：
影响因子：
--
通讯作者：
Shimizu W
中科院分区：
文献类型：
--
作者：
Kubota Y;Yamamoto T;Tara S;Tokita Y;Yodogawa K;Iwasaki Y;Takano H;Tsukada Y;Asai K;Miyamoto M;Miyauchi Y;Kodani E;Sato N;Tanabe J;Shimizu W
防止致死性室性心律失常导致心脏性猝死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预后不良和致命性心律失常有关，可以通过心率变异性、心率震荡、T波电交替、晚电位和123 I-间碘苄基胍（123 I-MIBG）脑电描记术进行非侵入性评估。钠葡萄糖协同转运蛋白2（SGLT 2）抑制剂可能会降低交感神经系统的活性，这种活性部分是由于高血糖的刺激作用而增强的。该试验旨在确定SGLT 2抑制剂诱导的心脏交感神经活动抑制是否伴随着对不良心血管结局的保护。该试验是一项在日本急性心肌梗死和2型糖尿病患者中进行的前瞻性、多中心、随机、双盲、安慰剂对照试验。共有98例患者将随机（1：1）接受安慰剂或恩格列净（SGLT 2抑制剂，10 mg）每日一次治疗。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（如心率震荡、T波电交替、晚电位和123 I-MIBG脑电成像）较基线的变化。将在整个试验期间评价不良反应。该试验将评估恩格列净的潜在心脏保护作用，并将提供关于其对心脏性猝死的预防作用的其他重要新数据。唯一试验编号，UMIN 000030158（https：upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi? recptno=R000034442）。Nippon Boehringer Ingelheim and Eli Lilly and Company。
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 123I-meta-iodobenzylguanide (123I-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 123I-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.
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影响因子：
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