SGLT2 inhibitor TrEatment iN patients awaiting cOronary arTery bYpass surgery to reduce Post-opErative atrial fibrillation and kidney injury (STENOTYPE trial).

Conditions

Onset of Atrial Fibrillation and Acute Kidney Injury after coronary artery bypass surgery (CABG)

Brief summary

AF lasting at least 30 seconds as detected on ECG or telemetry in-hospital after CABG surgery.

Detailed description

AKI, as defined by at least a 1.5-fold increase from baseline in serum creatinine within the prior seven days, an absolute increase in serum creatinine of 26.5 µmol/L or more within 48 hours, or a urine volume of less than 0.5 mL/kg/h for at least six hours, following Kidney Disease Improving Global Outcomes grade 1 or above. This condition is monitored in-hospital after CABG surgery., Safety and tolerability of dapagliflozin. Reported AEs, SAEs, and SUSAR from start of treatment until one-week post-discharge., All-cause mortality., Stroke., New onset heart failure., Ventricular arrhythmia., Electrical cardioversion for AF., Use of amiodarone for AF., Change in inflammatory and cardiac biomarkers from baseline to end of CABG surgery, 6±2 hours, 12±2 hours, and three days after CABG surgery., Change in HbA1c from baseline to three days after CABG surgery., Length of intensive care unit and hospital stay., 30-day all-cause mortality., 12-month all-cause mortality, 12-month myocardial infarction., 12-month stroke., 12-month hospital admission for AF or heart failure., 12-month dialysis treatment.

Related papers

No related papers found yet.

Interventions

DRUGPlacebo tablet. View the simplified IMPD for description and composition.

DRUGForxiga 10 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
AF lasting at least 30 seconds as detected on ECG or telemetry in-hospital after CABG surgery.	—

Secondary

Measure	Time frame
AKI, as defined by at least a 1.5-fold increase from baseline in serum creatinine within the prior seven days, an absolute increase in serum creatinine of 26.5 µmol/L or more within 48 hours, or a urine volume of less than 0.5 mL/kg/h for at least six hours, following Kidney Disease Improving Global Outcomes grade 1 or above. This condition is monitored in-hospital after CABG surgery., Safety and tolerability of dapagliflozin. Reported AEs, SAEs, and SUSAR from start of treatment until one-week post-discharge., All-cause mortality., Stroke., New onset heart failure., Ventricular arrhythmia., Electrical cardioversion for AF., Use of amiodarone for AF., Change in inflammatory and cardiac biomarkers from baseline to end of CABG surgery, 6±2 hours, 12±2 hours, and three days after CABG surgery., Change in HbA1c from baseline to three days after CABG surgery., Length of intensive care unit and hospital stay., 30-day all-cause mortality., 12-month all-cause mortality, 12-month myocardial inf	—

Measure

Time frame

AKI, as defined by at least a 1.5-fold increase from baseline in serum creatinine within the prior seven days, an absolute increase in serum creatinine of 26.5 µmol/L or more within 48 hours, or a urine volume of less than 0.5 mL/kg/h for at least six hours, following Kidney Disease Improving Global Outcomes grade 1 or above. This condition is monitored in-hospital after CABG surgery., Safety and tolerability of dapagliflozin. Reported AEs, SAEs, and SUSAR from start of treatment until one-week post-discharge., All-cause mortality., Stroke., New onset heart failure., Ventricular arrhythmia., Electrical cardioversion for AF., Use of amiodarone for AF., Change in inflammatory and cardiac biomarkers from baseline to end of CABG surgery, 6±2 hours, 12±2 hours, and three days after CABG surgery., Change in HbA1c from baseline to three days after CABG surgery., Length of intensive care unit and hospital stay., 30-day all-cause mortality., 12-month all-cause mortality, 12-month myocardial inf

—

Countries

Czechia, Denmark, Sweden

Outcome results

None listed