恩格列净对慢性心力衰竭且射血分数降低患者血容量再分布的影响：来自Empire HF随机临床试验的分析
Effect of Empagliflozin on Blood Volume Redistribution in Patients With Chronic Heart Failure and Reduced Ejection Fraction: An Analysis From the Empire HF Randomized Clinical Trial.
作者信息
Omar Massar, Jensen Jesper, Burkhoff Daniel, Frederiksen Peter H, Kistorp Caroline, Videbæk Lars, Poulsen Mikael Kjær, Gustafsson Finn, Køber Lars, Borlaug Barry A, Schou Morten, Møller Jacob Eifer
机构信息
Department of Cardiology, Odense University Hospital, Denmark (M.O., P.H.F., L.V., M.K.P., J.E.M.).
Steno Diabetes Center Odense, Denmark (M.O.).
出版信息
Circ Heart Fail. 2022 Mar;15(3):e009156. doi: 10.1161/CIRCHEARTFAILURE.121.009156. Epub 2021 Nov 8.
BACKGROUND
Stressed blood volume (SBV) is a major determinant of systemic and pulmonary venous pressures which, in turn, determine left and right ventricular fillings and regulates cardiac output via the Frank-Starling mechanism. It is not known whether inhibition of the SGLT2 (sodium-glucose cotransporter-2) favorably affects SBV. We investigated the effect of empagliflozin on estimated SBV in patients with heart failure and reduced ejection fraction compared with placebo.
METHODS
This was a post hoc analysis of an investigator-initiated, double-blinded, placebo-controlled, randomized trial. Seventy patients were assigned to empagliflozin 10 mg or matching placebo once daily for 12 weeks. Patients underwent right heart catheterization at rest and during exercise at baseline and follow-up. The outcome was change in estimated SBV after 12 weeks of empagliflozin treatment over the full range of exercise, determined using a recently introduced analytical approach based on invasive hemodynamic assessment.
RESULTS
Patients with heart failure and reduced ejection fraction, mean age, 57 years and mean ejection fraction 27%, with 47 patients (71%) receiving diuretics were randomized. The effect of empagliflozin on estimated SBV over the full range of exercise loads showed a statistically significant reduction compared with placebo (-198.4 mL [95% CI, -317.4 to -79.3] =0.001), a 9% decrease. The decrease in estimated SBV by empagliflozin was significantly correlated with the decrease in PCWP (=-0.33, <0.0001). The effect of empagliflozin was consistent across subgroup analysis.
CONCLUSIONS
Empagliflozin treatment significantly reduced SBV compared with placebo after 12 weeks of treatment in patients with stable chronic heart failure and reduced ejection fraction during sub maximal exercise.
REGISTRATION
URL: https://www.
CLINICALTRIALS
gov; Unique identifier: NCT03198585.
背景
应激血容量（SBV）是体循环和肺静脉压力的主要决定因素，而体循环和肺静脉压力又决定左、右心室充盈，并通过Frank-Starling机制调节心输出量。目前尚不清楚抑制钠-葡萄糖协同转运蛋白2（SGLT2）是否对SBV有有利影响。我们研究了与安慰剂相比，恩格列净对射血分数降低的心力衰竭患者估计SBV的影响。
方法
这是一项对研究者发起的双盲、安慰剂对照、随机试验的事后分析。70例患者被随机分配至每日一次服用10mg恩格列净或匹配安慰剂，为期12周。患者在基线和随访时静息及运动状态下接受右心导管检查。结局指标为采用一种基于有创血流动力学评估的最新分析方法，在整个运动范围内恩格列净治疗12周后估计SBV的变化。
结果
射血分数降低的心力衰竭患者，平均年龄57岁，平均射血分数27%，47例（71%）接受利尿剂治疗，被随机分组。与安慰剂相比，恩格列净在整个运动负荷范围内对估计SBV的影响显示有统计学意义的降低（-198.4 mL[95%CI，-317.4至-79.3]；P=0.001），降低了9%。恩格列净使估计SBV的降低与肺毛细血管楔压（PCWP）的降低显著相关（r=-0.33，P<0.0001）。恩格列净的作用在亚组分析中是一致的。
结论
在稳定的慢性心力衰竭且次极量运动时射血分数降低的患者中，治疗12周后，与安慰剂相比，恩格列净治疗显著降低了SBV。
注册
网址：https://www.
临床试验
gov；唯一标识符：NCT03198585。
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