• Shunsuke Tamaki, Takahisa Yamada, Tetsuya Watanabe, Takashi Morita, Yoshio Furukawa, Masato Kawasaki, Atsushi Kikuchi, Tsutomu Kawai, Masahiro Seo, Makoto Abe, Jun Nakamura, Kyoko Yamamoto, Kiyomi Kayama, Masatsugu Kawahira, Kazuya Tanabe, Kei Fujikawa, Masahisa Hata, Yohei Fujita, Yutaka Umayahara, Satsuki Taniuchi, Shoji Sanada, Ayumi Shintani, and Masatake Fukunami.
• Division of Cardiology (S.T., T.Y., T.W., T.M., Y.F., M.K., A.K., T.K., M.S., M.A., J.N., K.Y., K.K., M.K., K.T., M.F), Osaka General Medical Center, Osaka, Japan.
• Circ Heart Fail. 2021 Mar 1; 14 (3): e007048.

BackgroundEmpagliflozin 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.MethodsThe 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.ResultsThere 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.ConclusionsIn 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.

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