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SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative AF
Sponsor: Region Örebro County
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. 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.
Official title: SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative Atrial Fibrillation and Kidney Injury (STENOTYPE Trial)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
800
Start Date
2024-04-04
Completion Date
2028-12-04
Last Updated
2025-04-08
Healthy Volunteers
No
Interventions
Dapagliflozin 10mg Tab
Dapagliflozin once daily for a minimum of seven days while awaiting scheduled CABG and up until discharge with a short interruption for surgery.
Placebo Tab
Matching placebo once daily for a minimum of seven days while awaiting scheduled CABG and up until discharge with a short interruption for surgery.
Locations (8)
St. Anne University Hospital
Brno, Czechia
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark
Aarhus, Denmark
Department of Cardiothoracic Surgery, Kobenhavn
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Sahlgrenska University Hospital
Gothenburg, Sweden
Linköping University Hospital
Linköping, Sweden
Skane University Hospital
Lund, Sweden
Department of cardiology
Örebro, Sweden