Efficacy of Empagliflozin in Patients With Heart Failure and Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Maintenance of sinus rhythm after the blanking period
研究概览
简要总结
The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared with placebo, in patients with diabetes mellitus or overweight, heart failure and atrial fibrillation.
详细描述
A 24-month randomized, single-blind, placebo-controlled trial to investigate the efficacy of empagliflozin to reduce atrial fibrillation burden in patients with diabetes mellitus or overweight, heart failure and atrial fibrillation in which a rhythm control strategy is indicated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Age 18-80 years
- •Diabetes mellitus or Body Mass Index over 25 Kg/m2
- •Heart failure
- •New York Heart Association (NYHA) Functional Classification: II or III
- •Documented atrial fibrillation
- •Understands the nature of the study, treatment procedure and provides written informed consent
- •Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements
- •Expected to remain available for at least 24 months after enrollment
排除标准
- •Permanent atrial fibrillation
- •Current use or prior use of a sodium-glucose co-transporter (SGLT) 2 inhibitor or combined inhibitor of SGLT-1 and SGLT-2 (all the other antidiabetic drugs are permitted performing an accurate glycemic control)
- •Known allergy or hypersensitivity to any SGLT-2 inhibitors
- •History of ketoacidosis
- •Need or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
- •New York Heart Association (NYHA) Functional Classification: I or IV
- •Unstable angina
- •Presence of any disease that is likely to shorten life expectancy to < 1 year
- •Any cardiac surgery within three months prior to enrolment
- •Awaiting cardiac transplantation or other cardiac surgery within the next year
- •Myocardial infarction within 60 days prior to enrolment
- •Contraindications to oral anticoagulation
- •Active systemic infection or sepsis
- •Left atrial thrombus (e.g., transesophageal echocardiography, computed tomography and intracardiac echocardiography)
- •History of a documented thromboembolic event such as stroke or transient ischemic neurological attack in the three months prior to enrollment
- •Currently enrolled in another trial that has not completed the required follow-up period and would conflict with this study
- •Chronic liver diseases
- •Chronic kidney disease (creatinine clearance < 45 ml/min)
- •Pregnant or breast-feeding mothers
- •Any other clinical condition that might jeopardize patient safety during participation in this trial or prevent the subject from adhering to the trial protocol
研究组 & 干预措施
Empagliflozin
Empagliflozin 10 mg oral tablet, once daily, for 24 months
干预措施: Empagliflozin (Drug)
Placebo
Empagliflozin matching placebo oral tablet, once daily for 24 months
干预措施: Placebo (Other)
结局指标
主要结局
Maintenance of sinus rhythm after the blanking period
时间窗: From 90 days after baseline to 24-months
To compare the proportion of patients with sinus rhythm from 90 days after baseline to end of study period
次要结局
- Safety endpoint: Incidence of adverse events(Baseline through 24-months)
- Composite of major adverse cardiovascular events(Baseline through 24-months)
- Hospitalizations for cardiovascular events(Baseline through 24-months)
研究者
Massimo Grimaldi
Head of Arrhythmology and Electrophysiology Unit
Miulli General Hospital