Clinical trial NCT06124937: Empagliflozin to Prevent Post-Operative Atrial Fibrillation
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Post-operative Atrial Fibrillation
CABG
Keywords: Atrial Fibrillation
CABG
Cardiac surgery
Empagliflozin
Post-operative AF
SGLT2 inhibitors
Lead sponsor: Rajaie Cardiovascular Medical and Research Center
Sponsor class: OTHER
Collaborators: name: Tehran Heart Center
First posted: 2023-11-09
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms, parallel-group, phase 3, randomized, double-blind, placebo-controlled trial with allocation sequence concealment and blinded endpoint adjudication on 492 patients
Primary purpose: PREVENTION

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 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.

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-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 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

Primary outcomes:
measure: Incidence of POAF
timeFrame: From CABG until discharge from the intensive care unit (at least 72 hours and maximum 30 days)
Secondary outcomes:
measure: Composite Incidence of all arrhythmias leading to hemodynamic instability
timeFrame: From CABG until discharge from the hospital (maximum 30 days).
measure: Incidence of post-operative acute kidney injury
timeFrame: From CABG until 7th post-operation day.
measure: Need for vasopressor/inotrope
timeFrame: From CABG until discharge from the intensive care unit (maximum 30 days).
measure: Duration of hospitalization
timeFrame: From CABG until discharge from the hospital.
measure: All-cause mortality
timeFrame: From CABG until 30th post-operation day.
measure: Incidence of life-threatening infections
timeFrame: From CABG until discharge (maximum 30 days).
measure: Incidence of genitourinary tract infections
timeFrame: From CABG until discharge from the hospital (maximum 30 days).
measure: Incidence of hypoglycemia
timeFrame: From CABG until discharge from the hospital (maximum 30 days).
measure: Incidence of ketoacidosis
timeFrame: From CABG until discharge from the hospital (maximum 30 days).
measure: Incidence of clinically-diagnosed ischemic stroke
timeFrame: From CABG until 30th post-operation day.
measure: Composite incidence of arterial and venous thrombosis
timeFrame: From CABG until 30th post-operation day.
measure: Need for renal replacement therapy
timeFrame: From CABG until discharge from the intensive care unit (maximum 30 days).
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran Heart Center
city: Tehran
country: Iran, Islamic Republic of
facility: Rajaie Cardiovascular Medical & Research Center
Study officials:
References: