Empagliflozin to Prevent Post-Operative Atrial Fibrillation

• Status: Recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rajaie Cardiovascular Medical and Research Center
• Collaborator: Tehran Heart Center
• Treatments: Empagliflozin

Criteria

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