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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin | Experimental | Empagliflozin 25 mg once daily for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 25 MG | Drug | Empagliflozin once daily, for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmogenic burden | Analysis of the T-wave heterogeneity index | 3 months |
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Inclusion Criteria:
• Age ≥ 18 years;
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Caramelli, MD, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| InCor | São Paulo | São Paulo | 05403-000 | Brazil |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003327 | Coronary Disease |
| D001145 | Arrhythmias, Cardiac |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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Patient data will be compared before and after treatment
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| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |