Effect of EMPAgliflozin on The HeterogeneitY of Ventricular Repolarization in Patients With Diabetes and Coronary HEART Disease.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Arrhythmogenic burden
研究概览
简要总结
The present project aims to investigate if the empagliflozin has an antiarrhythmic action. Analyzing the T-wave heterogeneity index, a new electrocardiographic risk marker associated with the prediction of cardiovascular risk, in diabetic patients and coronary artery disease, the investigators will verify if empagliflozin is associated with a reduction in electrical instability.
详细描述
Cardiovascular diseases are the leading cause of morbidity and mortality in diabetic patients.
New hypoglycemic drugs are required to undergo cardiovascular safety studies for their release. In 2015, EMPA-REG OUTCOME, which was done for empagliflozin´s approval was the first study to provide evidence that an antidiabetic agent could decrease cardiovascular events. The results demonstrated a reduction in the primary outcome (death by cardiovascular causes, nonfatal infarction, and nonfatal stroke), cardiovascular mortality and hospitalization for heart failure in patients with type 2 diabetes at high cardiovascular risk who received empagliflozin in combination with standard treatment. It is noteworthy that the study population was under-optimized clinical treatment with antihypertensives, statin and aspirin and especially it is noteworthy that the difference in the primary outcome over placebo became evident only three months after treatment´s start.
The potential mechanisms underlying the surprising cardiovascular benefits of empagliflozin are not fully understood.
The present project aims to investigate if the empagliflozin has an antiarrhythmic action. Analyzing the T-wave heterogeneity index, a new electrocardiographic risk marker associated with the prediction of cardiovascular risk, in diabetic patients and coronary artery disease, we will verify if empagliflozin is associated with a reduction in electrical instability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age ≥ 18 years;
- •Fasting glycemia> 100 mg/dl or previous diagnosis of type 2 diabetes mellitus;
- •Coronary artery disease, defined by one of the following criteria: the antecedent of myocardial infarction; the evidence of significant coronary stenosis in previous coronary angiography; the noninvasive positive test for ischemia (stress electrocardiogram, stress echocardiogram, stress scintigraphy)
- •TWH ≥ 80 microvolts
排除标准
- •Chronic renal insufficiency with glomerular filtration rate ≤ 45 ml / min / 1.73m2;
- •Hepatic insufficiency (determined by Child-Pugh, B or C classification);
- •Age ≥ 85 years;
- •12-lead resting electrocardiogram with the following changes: intraventricular conduction disorders (bundle branch block), pacemaker rhythm, atrial fibrillation or flutter, artifact stroke distortion or baseline fluctuation
研究组 & 干预措施
Empagliflozin
Empagliflozin 25 mg once daily for 3 months
干预措施: Empagliflozin 25 MG (Drug)
结局指标
主要结局
Arrhythmogenic burden
时间窗: 3 months
Analysis of the T-wave heterogeneity index
次要结局
未报告次要终点
研究者
Bruno Caramelli
Associated Professor of Medicine
University of Sao Paulo