A Phase 3 interventional study of Empagliflozin 10 MG and Placebo in Post-operative Atrial Fibrillation and CABG, sponsored by Rajaie Cardiovascular Medical and Research Center. Status unknown at 2 sites in Iran. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Rajaie Cardiovascular Medical and Research Center · Phase 3, Interventional, and Prevention
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.
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.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's planned enrollment of 492 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Rajaie Cardiovascular Medical and Research Center is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
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Exclusion criteria
The intervention group will receive a 10 mg tablet of empagliflozin once a day from 3 days before surgery until discharge from the hospital.
Drug: Empagliflozin 10 MG
The comparator group will receive a matching placebo
Drug: Placebo
The intervention group will receive a 10 mg tablet of empagliflozin once a day from 3 days before surgery until discharge from the hospital.
The comparator group will receive a matching placebo from 3 days before surgery until discharge from the hospital.
Incidence of POAF
Incidence of new-onset postoperative atrial fibrillation (AF) and/or atrial flutter (AFL), defined as any adjudicated documented AF or AFL of at least 30 seconds duration and documented by Holter ECG monitoring during the admission time in the ICU (at least 72 hours and maximum 30 days).
Time frame: From CABG until discharge from the intensive care unit (at least 72 hours and maximum 30 days)
Composite Incidence of all arrhythmias leading to hemodynamic instability
Defined as any adjudicated documented tachy- or bradyarrhythmia of at least 30 seconds duration and documented by rhythm strips or 12-lead ECG leading to hemodynamic instability during the admission time. Ventricular tachycardia (VT) of at least 30 seconds duration and documented by rhythm strip or 12-lead ECG. Ventricular fibrillation (VF) of at least 30 seconds duration and documented by rhythm strip or 12-lead ECG
Time frame: From CABG until discharge from the hospital (maximum 30 days).
Incidence of post-operative acute kidney injury
Defined as the presence of either the increase in serum creatinine by ≥ 0.3 mg/dl (≥ 26.5 µmol/l) within 48 hours; or an increase in serum creatinine to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or urine volume \< 0.5 ml/kg/h for 6 hours based on the KDIGO definition of AKI
Time frame: From CABG until 7th post-operation day.
Need for vasopressor/inotrope
Defined as cumulative vasopressor index and the amount of average daily inotrope dose during the admission time in the ICU
Time frame: From CABG until discharge from the intensive care unit (maximum 30 days).
Duration of hospitalization
Defined as number of days a patient stay at the hospital
Time frame: From CABG until discharge from the hospital.
All-cause mortality
Defined as adjudicated 30-day mortality, including cause-specific mortality: cardiac arrhythmic, cardiac non-arrhythmic, and non-cardiovascular.
Time frame: From CABG until 30th post-operation day.
Incidence of life-threatening infections
Defined as any adjudicated laboratory and clinically confirmed systemic infection that necessitate the administration of parenteral broad spectrum antibiotics
Time frame: From CABG until discharge (maximum 30 days).
Incidence of genitourinary tract infections
Defined as any adjudicated laboratory and clinically confirmed genitourinary tract infection including cystitis, pyelonephritis, prostatitis, urethritis, and vaginitis
Time frame: From CABG until discharge from the hospital (maximum 30 days).
Incidence of hypoglycemia
Defined as serum blood sugar ≤ 70 mg/dL (≤ 3.9 mmol/L)
Time frame: From CABG until discharge from the hospital (maximum 30 days).
Incidence of ketoacidosis
Defined as blood pH ≤ 7.3, serum bicarbonate less than 15 mEq/l, and presence of ketonemia or ketonuria
Time frame: From CABG until discharge from the hospital (maximum 30 days).
Incidence of clinically-diagnosed ischemic stroke
Defined as the sudden loss of blood circulation to an area of the brain that has been confirmed with appropriate diagnostic imaging (Brain CT/MRI)
Time frame: From CABG until 30th post-operation day.
Composite incidence of arterial and venous thrombosis
Defined as adjudicated arterial thrombosis (including Type I MI and peripheral arterial thrombosis) and venous thrombosis (including DVT and PE) confirmed with appropriate diagnostic tools
Time frame: From CABG until 30th post-operation day.
Need for renal replacement therapy
defined as treatment with any forms of dialysis (hemodialysis, hemodiafiltration, and peritoneal dialysis), hemofiltration, and renal transplantation
Time frame: From CABG until discharge from the intensive care unit (maximum 30 days).
Plan to share: Undecided
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Started Nov 2023 (actual). Primary completion is estimated for Dec 2024, 13 months after the start.
Of 56 non-industry phase 3 interventional studies under Atrial Fibrillation, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 73. This study's planned 13 months is below that.
Counting every sponsor, half of 76 studies reached it within 47 months; a quarter within 28 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Empagliflozin
Rajaie Cardiovascular Medical and Research Center