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

Korábbi kezelés

• Treatment with an SGLT2 inhibitor within 8 weeks prior to enrolment or planned treatment.
• Current acute decompensated heart failure or hospitalization due to decompensated heart failure <4 weeks prior to enrolment.
• Implantation or intent to implant a cardiac resynchronization device within 12 weeks prior to enrolment.
• Stroke or transient ischemic attack within 12 weeks prior to enrolment.
• CABG surgery planned within one week.
• Emergency surgery with hemodynamic instability.
• Previous history of AF.
• Participation or recent participation in a clinical trial with an investigational medicinal product within 30 days before randomization.
• Previous randomization in the STENOTYPE trial.
• Previous (within 30 days) or concomitant participation in another clinical trial with an investigational product. Registries and observational studies are allowed.

Más betegség

• Intolerance, hypersensitivity, or other contraindications of dapagliflozin.
• Type 1 diabetes mellitus.
• Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic cardiomyopathy.
• Severe (estimated glomerular filtration rate < 25 mL/min/1.73 m2), unstable, or rapidly progressing renal disease at the time of enrolment.

Laborértékek

• Hepatic impairment (aspartate transaminase or alanine transaminase >3 × the upper limit of normal, or total bilirubin >2 × upper limit of normal at the time of enrolment).

Életkor

• Any condition such as, but not limited to, malignancy, with a life expectancy of <2 years based on the investigator's clinical judgement.

Egyéb

• Symptomatic hypotension or systolic blood pressure <95 mmHg at two out of three measurements at enrolment.
• Symptomatic bradycardia or second or third-degree atrioventricular block without pacemaker treatment.
• Women of childbearing potential (i.e., those who are fertile, following menarche and until becoming post-menopausal, unless permanently sterile*)
  • Who are not willing to use a highly effective method of contraception** judged by the investigator, from the time of signing the informed consent throughout the trial and 4 weeks thereafter, OR
  • Who have a positive pregnancy test at enrolment or randomization, OR
  • Who are breast-feeding.
• Mental inability, reluctance, or language difficulties of the subject, in the opinion of the investigator, that result in difficulty in understanding the meaning of participation in the trial.

• 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.