Trial DesignsEarly treatment with a sodium-glucose co-transporter 2 inhibitor in high-risk patients with acute heart failure: Rationale for and design of the EMPA-AHF trial
Graphical Abstract
Section snippets
Trial structure and oversight
The EMPA-AHF trial is a multicentre, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of early initiation of once-daily oral empagliflozin 10 mg in patients hospitalized for AHF. The trial has been registered at ClinicalTrials.gov (NCT05392764), and is being conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. This study has been reviewed and approved by the
Discussion
The EMPA-AHF trial is the first to evaluate the efficacy and safety of the early initiation of empagliflozin (10 mg) in patients with AHF expected to be at high risk when treated with conventional therapy. The results of this study will provide invaluable information regarding the important and clinically relevant question, whether a modification of the treatment strategy early after hospital presentation with empagliflozin for high-risk patients with AHF impacts their clinical course.
There are
Conclusion
The EMPA-AHF trial will evaluate the efficacy and safety of initiating empagliflozin in the acute phase before clinical stabilization in high-risk patients with AHF. This study may provide invaluable information for optimizing treatment according to risk stratification in patients with AHF.
Funding
This work was supported by Nippon Boehringer Ingelheim Co., Ltd., and Eli Lilly Japan K.K, who were involved in the planning of this study and the provision of information for the proper use of research drugs, but will not be involved in the conduct or analysis of this study.
Conflict of Interest
Y.H. received an honorarium from Otsuka Pharmaceutical Co, Novartis Japan, AstraZeneca, and Nippon Boehringer Ingelheim Co., Ltd. Y. M. received an honorarium from Otsuka Pharmaceutical Co, Novartis Japan, Bayer Inc., and AstraZeneca, and collaborative research grant from Pfizer Japan Inc., Otsuka Pharmaceutical Co and EN Otsuka Pharmaceutical Co., Ltd. D.N. is an employee of Nippon Boehringer Ingelheim Co. Ltd. K.D. received speaker fees from Abbott, Astra Zeneca and Boehringer Ingelheim. K.Y.
Acknowledgment
None.
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Y. Horiuchi and Y. Matsue contributed equally.