Arrythmia, Cardiac, Coronary Heart Disease, Diabetes Mellitus, Type 2
Conditions
Keywords
empagliflozin, Diabetes, coronary heart disease
Brief summary
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.
Detailed description
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.
Interventions
DRUGEmpagliflozin 25 MG
Empagliflozin once daily, for three months
Sponsors
University of Sao Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Patient data will be compared before and after treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* • 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmogenic burden | 3 months | Analysis of the T-wave heterogeneity index |
Countries
Brazil
Outcome results
None listed