Effect of Empagliflozin on Ventricular Repolarization. (EMPATHYHEART)
Primary Purpose
Diabetes Mellitus, Type 2, Coronary Heart Disease, Arrythmia, Cardiac
Status
Recruiting
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Empagliflozin 25 MG
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes Mellitus, Type 2 focused on measuring empagliflozin, Diabetes, coronary heart disease
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)
- 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
Sites / Locations
- InCorRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Empagliflozin
Arm Description
Empagliflozin 25 mg once daily for 3 months
Outcomes
Primary Outcome Measures
Arrhythmogenic burden
Analysis of the T-wave heterogeneity index
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04117763
Brief Title
Effect of Empagliflozin on Ventricular Repolarization.
Acronym
EMPATHYHEART
Official Title
Effect of EMPAgliflozin on The HeterogeneitY of Ventricular Repolarization in Patients With Diabetes and Coronary HEART Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Coronary Heart Disease, Arrythmia, Cardiac
Keywords
empagliflozin, Diabetes, coronary heart disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Patient data will be compared before and after treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Empagliflozin
Arm Type
Experimental
Arm Description
Empagliflozin 25 mg once daily for 3 months
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 25 MG
Intervention Description
Empagliflozin once daily, for three months
Primary Outcome Measure Information:
Title
Arrhythmogenic burden
Description
Analysis of the T-wave heterogeneity index
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Caramelli, MD, PhD
Phone
+5511984570650
Email
bcaramel@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Cristiane Lauretti, MD
Phone
+5511986399660
Email
crislauretti@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Caramelli, MD, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
InCor
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Caramelli, MD, PhD
Phone
11984570650
Email
bcaramel@usp.br
First Name & Middle Initial & Last Name & Degree
Cristiane Lauretti, MD
Phone
+5511986399660
Email
crislauretti@usp.br
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Empagliflozin on Ventricular Repolarization.
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