Multicenter, randomized, double-blind. parallel-group, placebo-controlled, clinical trial. Phase III clinical trial.

Atrial fibrillation (AF) and acute kidney injury are common post-operative complications in patients undergoing coronary artery bypass (CABG) surgery, thereby increasing mortality. This multicenter, prospective, randomized, comparator-controlled, double-blind, parallel-group, 2-arm clinical trial aims to compare the efficacy of the SGLT2 inhibitor dapagliflozin with placebo in preventing post-operative AF and acute kidney injury in patients undergoing CABG surgery.

Subjects will be randomized to 1 of the 2 arms: the intervention arm receiving a 10 mg tablet of dapagliflozin once daily and the comparator arm receiving a placebo tablet once daily for a minimum of 1 week while awaiting scheduled CABG surgery. Treatment will be terminated at time of discharge from hospital after CABG surgery. Standard clinical practice will be applied, with additional blood samples collected at specified times during hospitalization.

No. of subjects 800, trial period from June 2024 to January 2028

• To establish the efficacy of dapagliflozin in reducing the incidence of new onset post-operative AF during hospitalization following CABG surgery.
• To assess the effects of dapagliflozin on individual efficacy endpoints; the incidence of acute kidney injury, AF treatment, complications including in-hospital mortality, outcomes at 30-day and 12-month registry follow-ups, and safety.

• Ivy Susanne Modrau, Aarhus University Hospital, Aarhus, Denmark
• Anna Björkenheim (Sponsor), Ôrebro University Hospital, Örebro, Sweden
• Ole Fröbert, Örebro University Hospital, Örebro, Sweden
• Participants from several hospitals in Sweden and Denmark

• The Swedish Research Council
• The Swedish Heart Lung Foundation
• Nyckelfonden at Region Örebro county