Effects of Empagliflozin on Extracellular Volume, Plasma Volume, and Measured Glomerular Filtration Rate in Patients with Heart Failure: A Double-Blind, Randomised, and Placebo-Controlled Trial (Empire HF Renal)
Abstract
Background: Sodium-glucose co-transporter-2 inhibitors are a promising new treatment option for patients with heart failure and reduced ejection fraction (HFrEF) with and without type 2 diabetes. We investigated the effects of empagliflozin on estimated extracellular volume (ECV), estimated plasma volume, and measured glomerular filtration rate (GFR) in patients with HFrEF.
Methods: Empire HF Renal was an investigator-initiated, double-blind, placebo-controlled, randomised trial with recruitment from four hospitals in Denmark. Patients in New York Heart Association class I-III, with a left ventricular ejection fraction of 40% or lower, and on guideline-directed heart failure therapy were randomly assigned (1:1) to receive either oral empagliflozin 10 mg or placebo once daily for 12 weeks. The co-primary renal outcomes were the between-group difference in the change of estimated ECV, estimated plasma volume, and measured GFR from baseline to 12 weeks. The trial is registered at ClinicalTrials.gov (NCT03198585).
Findings: Between June 29, 2017, and July 15, 2019, 391 patients were screened and 120 (31%) were assigned to empagliflozin or placebo; 59 (98%) in the empagliflozin group and 58 (97%) in the placebo group were included in the analyses. Significant reductions in estimated ECV, estimated plasma volume, and measured GFR with empagliflozin versus placebo were observed [estimated ECV; adjusted mean difference of change empagliflozin versus placebo -0·12 L; 95% confidence…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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