Background:Empagliflozin reduces the risk of hospitalization for heart failure in patients with type 2 diabetes and cardiovascular disease. We sought to elucidate the effect of empagliflozin as an add-on therapy on decongestion and renal function in patients with type 2 diabetes admitted for acute decompensated heart failure.Methods:The study was terminated early due to COVID-19 pandemic. We enrolled 59 consecutive patients with type 2 diabetes admitted for acute decompensated heart failure. Patients were randomly assigned to receive either empagliflozin add-on (n=30) or conventional glucose-lowering therapy (n=29). We performed laboratory tests at baseline and 1, 2, 3, and 7 days after randomization. Percent change in plasma volume between admission and subsequent time points was calculated using the Strauss formula.Results:There were no significant baseline differences in left ventricular ejection fraction and serum NT-proBNP (N-terminal pro-B-type natriuretic peptide), hematocrit, or serum creatinine levels between the 2 groups. Seven days after randomization, NT-proBNP level was significantly lower in the empagliflozin group than in the conventional group (P=0.040), and hemoconcentration (≥3% absolute increase in hematocrit) was more frequently observed in the empagliflozin group than in the conventional group (P=0.020). The decrease in percent change in plasma volume between baseline and subsequent time points was significantly larger in the empagliflozin group than in the conventional group 7 days after randomization (P=0.017). The incidence of worsening renal function (an increase in serum creatinine ≥0.3 mg/dL) did not significantly differ between the 2 groups.Conclusions:In this exploratory analysis, empagliflozin achieved effective decongestion without an increased risk of worsening renal function as an add-on therapy in patients with type 2 diabetes with acute decompensated heart failure.Registration:URL: https://www.umin.ac.jp/ctr/index.htm; Unique identifier: UMIN000026315.

中文翻译：

---

依帕格列净作为补充治疗对急性失代偿性心力衰竭住院糖尿病患者的消退和肾功能的影响

背景：恩格列净可降低2型糖尿病和心血管疾病患者因心力衰竭住院的风险。我们试图阐明依帕格列净作为辅助疗法对因急性失代偿性心力衰竭而入院的2型糖尿病患者的充血和肾功能的影响。方法：该研究因COVID-19大流行而提前终止。我们招募了59例因急性失代偿性心力衰竭而住院的2型糖尿病患者。患者被随机分配接受依帕列净治疗（n = 30）或常规降糖治疗（n = 29）。我们在基线，随机分组后的1、2、3和7天进行了实验室测试。使用Strauss公式计算入院与随后各时间点之间血浆体积的百分比变化。两组之间左心室射血分数和血清NT-proBNP（N端pro-B型利尿钠肽），血细胞比容或血清肌酐水平无明显基线差异。随机分组后7天，依帕格列净组的NT-proBNP水平显着低于常规组（P = 0.040），依帕列净组的血药浓度（血细胞比容绝对增加≥3％）比常规组更明显（P = 0.020）。随机分配7天后，依帕格列净组基线和后续时间点之间血浆容量变化百分比的降低幅度明显大于常规组（P= 0.017）。两组之间肾功能恶化的发生率（血清肌酐增加≥0.3mg / dL）无显着差异。结论：在这项探索性分析中，依帕格列净实现了有效的充血，而没有增加肾功能恶化的风险。注册：URL：https://www.umin.ac.jp/ctr/index.htm; 唯一标识符：UMIN000026315。