Empagliflozin to Prevent Post-Operative Atrial Fibrillation
Iran492 participantsStarted 2023-11-07
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of POAF
Timeframe: From CABG until discharge from the intensive care unit (at least 72 hours and maximum 30 days)
Trial details
NCT IDNCT06124937
SponsorRajaie Cardiovascular Medical and Research Center