SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative AF

• Status: Not yet recruiting
• Trial end date: 2026-10-02
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this randomized, double-blinded, controlled clinical trial is to investigate if treatment with an sodium-glucose cotransporter-2 inhibitor (SGLT2) during the unique time window before coronary artery bypass surgery (CABG), can reduce the incidence of post-operative atrial fibrillation and/or acute kidney injury in patients with chronic coronary syndrome. The main questions it aims to answer are:

• Does treatment with an SGLT2 inhibitor during the waiting time and stable post-operative period, in patients with chronic coronary syndrome scheduled for CABG, reduce the risk of new onset atrial fibrillation compared to placebo?

• Does treatment with an SGLT2 inhibitor during the waiting time and stable post-operative period, in patients with chronic coronary syndrome scheduled for CABG, reduce the risk of acute kidney injury before hospital discharge compared to placebo? Participants will be administered dapagliflozin 10 mg once daily or placebo for a minimum of seven days while awaiting scheduled CABG and up until discharge, with a short interruption for surgery. Researchers will compare the active arm to the placebo arm to see if dapagliflozin can reduce the incidence of post-operative atrial fibrillation and/or acute kidney injury in patients with chronic coronary syndrome.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Region Örebro County
• Collaborators: Aarhus University Hospital; Brigham and Women's Hospital; Göteborg University; Harvard Medical School (HMS and HSDM); London School of Hygiene and Tropical Medicine; Odense University Hospital; Örebro University, Sweden; Sahlgrenska University Hospital, Sweden; Skane University Hospital; Swedish Heart Lung Foundation; The Swedish Research Council; University of Leeds
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• Patients with chronic coronary syndrome scheduled for CABG with extra corporeal circulation.

or

• Patients with chronic coronary syndrome scheduled for CABG and aortic valve replacement with extra corporeal circulation.

or

• Patients with chronic coronary syndrome scheduled for CABG and mitral valve surgery with extra corporeal circulation.

or

• Patients with chronic coronary syndrome scheduled for CABG and aortic root surgery

Exclusion Criteria:

• Current, recent or planned treatment with, or intolerance or contraindications, of a SGLT2 inhibitor.

• Type 1 diabetes mellitus.

• Symptoms of hypotension or systolic blood pressure <95 mmHg.

• Recent worsening of heart failure or other cardiovascular events or procedures.

• Any non-cardiovascular condition, e.g. malignancy, with a life expectancy of less than 2 years based on the investigator´s clinical judgement.

• Estimated glomerular filtration rate <20 mL/min/1.73 m2 or rapidly declining renal function.

• Cardiac surgery planned within seven days.

• Emergency surgery or hemodynamic instability.

• Previous history of atrial fibrillation.