Effect of Empagliflozin on Ventricular Repolarization.

Phase 4

Completed

• Conditions: Coronary Heart Disease; Arrythmia, Cardiac; Diabetes Mellitus, Type 2
• Interventions: Drug: Empagliflozin 25 MG

• Registration Number: NCT04117763
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-03
• Study Start: 2019-10-04
• Study First Posted: 2019-10-07
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Empagliflozin	Empagliflozin 25 MG	Empagliflozin 25 mg once daily for 3 months

Primary Outcome Measures

Name	Time	Method
Arrhythmogenic burden	3 months	Analysis of the T-wave heterogeneity index

Trial Locations

Locations (1)

InCor; 🇧🇷 São Paulo, SP, Brazil