Effect of Empagliflozin on Ventricular Repolarization. (EMPATHYHEART)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Coronary Heart Disease; Arrythmia, Cardiac
• Intervention / Treatment: Drug: Empagliflozin 25 MG

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403-000
      • InCor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Empagliflozin; Empagliflozin 25 mg once daily for 3 months	Drug: Empagliflozin 25 MG; Empagliflozin once daily, for three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arrhythmogenic burden	Analysis of the T-wave heterogeneity index	3 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Bruno Caramelli, MD, PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2019
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes; coronary heart disease; empagliflozin
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetes Mellitus; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus, Type 2; Arrhythmias, Cardiac; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Empagliflozin
• Other Study ID Numbers: 99613518.9.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No