Effect of Empagliflozin on Ventricular Repolarization.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-04

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Dapagliflozin on Electrocardiographic Parameters in Type 2 Diabetes Patients: DAPA - ECG Study

NCT06721442

Arrhythmias, Cardiac Diabetes Mellitus

COMPLETED PHASE4

Empagliflozin Versus Placebo on the Rate of Arrhythmic Events in Heart Failure Patients

NCT03271879

Heart Failure Diabetes Mellitus Arrythmia

UNKNOWN PHASE4

Empagliflozin on Patients With Preserved Heart Failure

NCT07112274

Heart Failure

COMPLETED NA

Empagliflozin in Hypertrophic Cardiomyopathy

NCT05182658

Hypertrophic Cardiomyopathy Heart Failure

UNKNOWN PHASE3

Dapagliflozin on Outcomes of Rhythm Control Strategy (Pharmacological ± Interventional) in Patient with Atrial Fibrillation

NCT06759909

Dapagliflozin (Forxiga) Atrial Fibrillation (AF)

NOT_YET_RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2 Coronary Heart Disease Arrythmia, Cardiac

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patient data will be compared before and after treatment

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Empagliflozin

Empagliflozin 25 mg once daily for 3 months

Group Type EXPERIMENTAL

Empagliflozin 25 MG

Intervention Type DRUG

Empagliflozin once daily, for three months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Empagliflozin 25 MG

Empagliflozin once daily, for three months

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No