Status:
UNKNOWN
Empagliflozin to Prevent Post-Operative Atrial Fibrillation
Lead Sponsor:
Rajaie Cardiovascular Medical and Research Center
Collaborating Sponsors:
Tehran Heart Center
Conditions:
Post-operative Atrial Fibrillation
CABG
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
492 Patients enrolled
Trial Details
Trial ID
NCT06124937
Start Date
November 7 2023
End Date
December 30 2024
Last Update
November 22 2023
Active Locations (2)
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1
Tehran Heart Center
Tehran, Iran, 1411713138
2
Rajaie Cardiovascular Medical & Research Center
Tehran, Iran, 1995614331