SGLT2 inhibitor treatment in patients awaiting coronary artery bypass surgery to reduce post-operative atrial fibrillation and kidney injury - A randomized, prospective, multicenter clinical trial

Background: New onset atrial fibrillation (AF) and/or acute kidney injury (AKI) following coronary bypass surgery are associated with twofold increased risk of stroke and mortality.

Meta-analyses of randomized controlled trial data point to a reduced risk of AF and inflammation with sodium-glucose cotransporter-2 (SGLT2) inhibitor treatment.Purpose and aims: To conduct a randomized, double-blinded, controlled clinical trial to investigate if treatment with an SGLT2 inhibitor during the unique time window before bypass surgery, can reduce the incidence of post-operative AF and/or AKI in patients with chronic coronary syndrome.Work plan: 800 patients in up to six Swedish and Danish hospitals will be randomized to treatment with an SGLT2 inhibitor (dapagliflozin) or placebo at least seven days before bypass surgery (2023 to 2025), interrupted for surgery and terminated at hospital discharge.

Primary outcome (AF) and key secondary outcome (AKI) will be assessed at discharge and from national registries 12 months after surgery (up to 2026). The applicant will act as primary investigator for coordination and conduction of the trial.

Preparations include applications for ethical and medical products agencies authority approval and creation of an external web page for randomization and data entry and recruitment of sites during 2023.

A simple preventive treatment to reduce post-operative complications can be implemented immediately in routine clinical care if positive findings.