Status:
COMPLETED
Effect of Empagliflozin on Ventricular Repolarization.
Lead Sponsor:
University of Sao Paulo
Conditions:
Diabetes Mellitus, Type 2
Coronary Heart Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 predicti...
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,...
Eligibility Criteria
Inclusion
- • 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
- 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
Key Trial Info
Start Date :
October 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04117763
Start Date
October 4 2019
End Date
March 31 2024
Last Update
May 8 2024
Active Locations (1)
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1
InCor
São Paulo, São Paulo, Brazil, 05403-000