JPRN-jRCTs031180185已完成4 期
Effect of Empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: Multi-Center placebo-controlled Double-Blind Randomized Trial - EMBODY trial
Shimizu Wataru0 个研究点目标入组 105 人开始时间: 2019年3月5日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
研究概览
简要总结
The EMBODY trial might provide the mechanisms by which empagliflozin reduces CV deaths, including SCD in AMI patients with type 2 diabetes mellitus. Intragroup comparison revealed a significant improvement in parameters reflecting both sympathetic and parasympathetic nerve activities in the empagliflozin group, whereas intergroup comparison showed no significant difference between the empagliflozin and placebo groups. The EMBODY trial demonstrated that these effects might be enhanced by empagliflozin, which is an SGLT2 inhibitor.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) 20 years or older at consent
- •2) Patients who meet the following items
- •- Subjects appropriately diagnosed as T2DM by the latest Japanese guideline
- •- Drug-naive subjects or taking single anti-diabetic agent
- •- T2DM patients who need to start, or are possibly changing or adding an anti-diabetic agent
- •3) Patients with acute myocardial infarction who can receive outpatient visits after discharge
排除标准
- •1) Type 1 diabetes mellitus
- •2) Persistent atrial fibrillation
- •3) Insulin, glucagon-like peptide-1 analogue, or other SGLT2 inhibitors user
- •4) High dose of sulfonylurea (glimepiride > 2 mg, glibenclamide > 1.25 mg, gliclazide > 40 mg)
- •5) HbA1c >= 10%
- •6) History of diabetic ketoacidosis or diabetic coma within 3 months prior to the randomization
- •7) Renal dysfunction (eGFR < 45 mL/min/1.73m2)
- •8) Heart failure graded at NYHA functional class IV
- •9) Pregnancy or possible pregnancy and breast feeding
- •10) Lack of informed consent
- •11) Patients judged by the investigator to be ineligible for inclusion in this study
- •12) Contraindicated for administration of empagliflozin
研究者
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