Using empagliflozin to prevent post-operative atrial fibrillation after heart surgery
Evaluating the Role of EMpagliflozin on the Rate of Post-Operative Atrial Fibrillation in Patients Undergoing Coronary Artery Bypass Graft Surgery: a Double-blind Placebo-controlled Randomized Clinical Trial
This study is testing if the medication empagliflozin can help prevent heart rhythm problems after heart surgery in adults.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 492 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Rajaie Cardiovascular Medical and Research Center Academic / other |
| Locations | 2 sites (Tehran and 1 other locations) |
| Trial ID | NCT06124937 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of empagliflozin, a sodium-glucose cotransporter-2 inhibitor, in reducing the incidence of post-operative atrial fibrillation in patients undergoing isolated coronary artery bypass graft (CABG) surgery. The study is a phase 3, double-blind, placebo-controlled trial involving 492 adult patients who will be randomly assigned to receive either empagliflozin or a placebo starting three days before their surgery. Participants will be monitored for atrial fibrillation using 24-hour ECG monitoring during their hospital stay. The trial is conducted at two major cardiology hospitals in Tehran.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and older who are scheduled for elective isolated CABG surgery.
Not a fit: Patients with a history of diabetes, atrial fibrillation, or other specified health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the occurrence of post-operative atrial fibrillation, improving recovery outcomes for patients undergoing heart surgery.
How similar studies have performed: Other studies have explored the use of SGLT2 inhibitors in various contexts, but this specific application in post-operative atrial fibrillation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tehran and 1 other locations
- Tehran Heart Center — Tehran, Iran, Islamic Republic of (Recruiting)
- Rajaie Cardiovascular Medical & Research Center — Tehran, Iran, Islamic Republic of (Recruiting)
Study contacts
- Study coordinator: Hessam Kakavand, PharmD
- Email: hessamkakavand@yahoo.com
- Phone: +982144605351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.