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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 492
- 试验地点
- 2
- 主要终点
- Incidence of POAF
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Neither the participants nor the researchers know which treatment or intervention patients are receiving
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intervention group
The intervention group will receive a 10 mg tablet of empagliflozin once a day from 3 days before surgery until discharge from the hospital.
干预措施: Empagliflozin 10 MG (Drug)
Comperator
The comparator group will receive a matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of POAF
时间窗: From CABG until discharge from the intensive care unit (at least 72 hours and maximum 30 days)
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).
次要结局
- Incidence of life-threatening infections(From CABG until discharge (maximum 30 days).)
- Composite Incidence of all arrhythmias leading to hemodynamic instability(From CABG until discharge from the hospital (maximum 30 days).)
- Incidence of post-operative acute kidney injury(From CABG until 7th post-operation day.)
- Need for vasopressor/inotrope(From CABG until discharge from the intensive care unit (maximum 30 days).)
- Duration of hospitalization(From CABG until discharge from the hospital.)
- All-cause mortality(From CABG until 30th post-operation day.)
- Incidence of genitourinary tract infections(From CABG until discharge from the hospital (maximum 30 days).)
- Incidence of hypoglycemia(From CABG until discharge from the hospital (maximum 30 days).)
- Incidence of ketoacidosis(From CABG until discharge from the hospital (maximum 30 days).)
- Incidence of clinically-diagnosed ischemic stroke(From CABG until 30th post-operation day.)
- Composite incidence of arterial and venous thrombosis(From CABG until 30th post-operation day.)
- Need for renal replacement therapy(From CABG until discharge from the intensive care unit (maximum 30 days).)