Overview
This is an interventional, double-blind, placebo controlled, multicenter, randomized clinical trial with allocation sequence concealment and blinded endpoint adjudication. The goal of present study is to investigate if periprocedural administration of 10 mg once daily empagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2I), can reduce the incidence of post-operative atrial fibrillation and/or atrial flutter in patients with chronic coronary syndrome scheduled for isolated CABG. This trial will be conducted in two referral teaching cardiology hospitals in Tehran. 492 adult patients who are scheduled for elective isolated coronary artery bypass graft (CABG) surgery will be randomly assigned to one of the groups of intervention (empagliflozin 10 mg daily) or placebo starting 3 days before surgery until discharge.
Description
Study aim: Evaluating the role of empagliflozin on the rate of postoperative atrial fibrillation in comparison with placebo Design: Two arms, parallel-group, phase 3, randomized, double-blind, placebo-controlled trial on 492 patients Settings and conduct: Recruitment site: Tehran Heart Center and Rajaie Cardiovascular Medical and Research Center For blinding, the drug or placebo will be given to the ward based on the patient's code in the randomization system For monitoring, the blood samples for creatinine, sodium, potassium, and fasting blood sugar along with clinical evaluations will be given on day 0 and daily thereafter (max= 30 days) in specific wards and will be compared at the end of any atrial fibrillation lasting longer than 30 seconds based on 24-hour 12-lead ECG monitoring will be accepted as atrial fibrillation After entering the study, the patients are placed in one of two groups, sample and control; in the sample group, they are treated with the usual treatment regimen plus empagliflozin at a dose of 10 mg during the hospitalization period. Patients in the control arm will receive a matching placebo.
Eligibility
Inclusion criteria
- Adult patients (≥18 years) who are candidates for isolated CABG
- Patients who provided written informed consent and are willing to participate in the study
Exclusion criteria
- History of type Ⅰ or Ⅱ diabetes mellitus
- History of ketoacidosis
- History of atrial fibrillation or flutter
- History of recurrent UTI
- SGLT2I or any other oral hypoglycemic medications used due to other indications
- Patients with acute kidney injury (45)
- Severe hepatic disease (Child-Pugh score C)
- Patients with Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73m2
- Patients who are candidates for emergent CABG
- Patients with unstable hemodynamic state
- Patients with positive urine culture, urinary symptoms (frequency, dysuria, hesitancy), and asymptomatic bacteriuria
- Patients who are enrolled in other clinical trials
- Patients with a history of drug-sensitive reactions to SGLT2I
- Pregnancy or lactation