Effect of Empagliflozin on Ventricular Repolarization.

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

Sponsors

Lead Sponsor: University of Sao Paulo

Source 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.

Overall Status Recruiting
Start Date October 4, 2019
Completion Date January 31, 2021
Primary Completion Date January 31, 2021
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Arrhythmogenic burden 3 months
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: Empagliflozin 25 MG

Description: Empagliflozin once daily, for three months

Arm Group Label: Empagliflozin

Eligibility

Criteria:

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)

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Bruno Caramelli, MD, PhD Principal Investigator University of Sao Paulo
Overall Contact

Last Name: Bruno Caramelli, MD, PhD

Phone: +5511984570650

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: InCor Bruno Caramelli, MD, PhD 11984570650 [email protected]
Location Countries

Brazil

Verification Date

April 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Sao Paulo

Investigator Full Name: Bruno Caramelli

Investigator Title: Associated Professor of Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Empagliflozin

Type: Experimental

Description: Empagliflozin 25 mg once daily for 3 months

Acronym EMPATHYHEART
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Patient data will be compared before and after treatment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov