Clinical trial NCT04117763: Effect of Empagliflozin on Ventricular Repolarization.
Official title: Effect of EMPAgliflozin on The HeterogeneitY of Ventricular Repolarization in Patients With Diabetes and Coronary HEART Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Coronary Heart Disease
Arrythmia, Cardiac
Keywords: empagliflozin
Diabetes
coronary heart disease
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patient data will be compared before and after treatment
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Arrhythmogenic burden
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: InCor
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Bruno Caramelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: