Effect of Empagliflozin on Ventricular Repolarization.

Diabetes Mellitus, Type 2 Clinical Trial

— EMPATHYHEART  

Official title:

Effect of EMPAgliflozin on The HeterogeneitY of Ventricular Repolarization in Patients With Diabetes and Coronary HEART Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117763
• Other study ID #: 99613518.9.0000.0068
• Status: Completed
• Phase: Phase 4
• Start date: October 4, 2019
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2024
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrythmia, Cardiac
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Diabetes Mellitus, Type 2
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Empagliflozin 25 MG
Empagliflozin once daily, for three months

Locations

Country	Name	City	State
Brazil	InCor	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrhythmogenic burden	Analysis of the T-wave heterogeneity index	3 months