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Randomized Controlled Trial
. 2022 Aug;9(4):2233-2238.
doi: 10.1002/ehf2.13955. Epub 2022 May 25.

Empagliflozin reduces markers of acute kidney injury in patients with acute decompensated heart failure

Kirsten Thiele  1 , Matthias Rau  1 , Niels-Ulrik Korbinian Hartmann  1 , Marcus Möller  2 , Julia Möllmann  1 , Joachim Jankowski  3   4 , András P Keszei  5 , Michael Böhm  6 , Jürgen Floege  2 , Nikolaus Marx  1 , Michael Lehrke  1
Affiliations
Randomized Controlled Trial

Empagliflozin reduces markers of acute kidney injury in patients with acute decompensated heart failure

Kirsten Thiele et al. ESC Heart Fail. 2022 Aug.

Abstract

Aims: In this prospective, placebo-controlled, double-blind, exploratory study, we examined early and more delayed effects of empagliflozin treatment on haemodynamic parameters (primary endpoint: cardiac output) and kidney function including parameters of acute kidney injury (AKI) in patients with acute decompensated heart failure (HF).

Methods and results: Patients with acute decompensated HF with or without diabetes were randomized to empagliflozin 10 mg or placebo for 30 days. Haemodynamic, laboratory, and urinary parameters were assessed after 6 h, 1 day, 3 days, 7 days, and 30 days of treatment. Median time between hospital admission and randomization was 72 h. Baseline characteristics were not different in the empagliflozin (n = 10) and placebo (n = 9) groups. Empagliflozin led to a significant increase in urinary glucose excretion throughout the study (baseline: 37 ± 15 mg/24 h; Day 1: 14 565 ± 8663 mg/24 h; P = 0.001). Empagliflozin did not affect the primary endpoint of cardiac index or on systemic vascular resistance index at any time point. However, empagliflozin significantly reduced parameters of AKI (urinary TIMP-2 and IGFBP7 by NephroCheck® as indicators of tubular kidney damage), which became significant after 3 days of treatment [placebo: 1.1 ± 1.1 (ng/mL)2 /1000; empagliflozin: 0.3 ± 0.2 (ng/mL)2 /1000; P = 0.02] and remained significant at the 7 day time point [placebo: 2.5 ± 3.8 (ng/mL)2 /1000; empagliflozin: 0.3 ± 0.2 (ng/mL)2 /1000; P = 0.003].

Conclusions: In this study, empagliflozin treatment did not affect haemodynamic parameters but significantly reduced markers of tubular injury in patients with acute decompensated HF.

Keywords: Acute decompensated heart failure; Acute kidney injury; Empagliflozin; Haemodynamic parameters; SGLT2 inhibitors.

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Conflict of interest statement

K.T., M.R., N.U.K.H., M.M., J.M., and A.K. report no potential conflict of interest. J.J. has given lectures for Bayer and Fresenius Medica Care. In addition, he holds four patents in the topic of the manuscript and is inventor of an additional, already sold patent to Baxter. M.B. received speaker honoraria from Astra‐Zeneca and Boehringer Ingelheim and was national coordinator of DAPA‐HF and EMPEROR‐Reduced. J.F. has received consultancy fees from AstraZeneca, Bayer, Boehringer, and Vifor and is a member of the data safety monitoring committee in NovoNordisk trials. N.M. has received support for clinical trial leadership from Boehringer Ingelheim and Novo Nordisk and served as a consultant to Boehringer Ingelheim, Merck, Novo Nordisk, and AstraZeneca. B.M.S. received grant support from Boehringer Ingelheim, Merck, and Novo Nordisk and served as a speaker for Boehringer Ingelheim, Merck, Novo Nordisk, Lilly, BMS, and Astra Zeneca. M.L. received grants and personal fees from Boehringer Ingelheim, MSD, and Novo Nordisk and personal fees from Amgen, Sanofi, Astra Zeneca, Bayer, and Lilly.

Figures

Figure 1
Figure 1
Effect of empagliflozin on markers of acute kidney injury (AKI). Urinary glucose excretion (A) and AKI risk markers (B) in patients with acute decompensated heart failure treated with empagliflozin (n = 10; black line) or placebo (n = 9; blue dotted line). Data are shown as mean ± standard error at baseline, after 1, 3, and 7 days. P‐values are calculated from the Wald tests for the intervention effect at each visit.
See this image and copyright information in PMC

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