About this trial
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. The active arm will be compared to the placebo arm to see if dapagliflozin can reduce the incidence of post-operative atrial fibrillation and/or acute kidney injury.
Eligibility criteria
Qualifiers
Written informed consent.
Patients aged 18 years or older.
Chronic coronary syndrome scheduled for elective isolated CABG surgery with extra corporeal circulation, or elective CABG surgery with extra corporeal circulation combined with aortic valve replacement, mitral valve surgery, and / or aortic root surgery.
Disqualifiers
Treatment with an SGLT2 inhibitor within 8 weeks prior to enrolment or planned treatment.
Intolerance, hypersensitivity, or other contraindications of dapagliflozin.
Type 1 diabetes mellitus.
Symptomatic hypotension or systolic blood pressure <95 mmHg at two out of three measurements at enrolment.
Trial design
Treatments tested in this trial
- Dapagliflozin 10mg Tab
- Placebo Tab
Treatment groups
Sponsors and collaborators
Region Örebro County
Lead sponsor
Odense University Hospital
Collaborator
Aarhus University Hospital
Collaborator
Örebro University, Sweden
Collaborator
Sahlgrenska University Hospital
Collaborator
Göteborg University
Collaborator
University of Leeds
Collaborator
Skane University Hospital
Collaborator
London School of Hygiene and Tropical Medicine
Collaborator
St. Anne's University Hospital Brno, Czech Republic
Collaborator
Mount Sinai Hospital, New York
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
University Hospital, Linkoeping
Collaborator
Rigshospitalet, Denmark
Collaborator