Effect of Empagliflozin on Ventricular Repolarization.

NCT04117763 | Completed Phase 4 DMC

• 1 other identifier: 99613518.9.0000.0068
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Coronary Heart Disease; Arrythmia, Cardiac

Keywords

empagliflozin; Diabetes; coronary heart disease

Outcome Measures

Primary Outcomes (1)

• Arrhythmogenic burden

  Analysis of the T-wave heterogeneity index

  3 months

Study Arms (1)

Empagliflozin

EXPERIMENTAL

Empagliflozin 25 mg once daily for 3 months

Drug: Empagliflozin 25 MG

Interventions

Empagliflozin 25 MG DRUG

Empagliflozin once daily, for three months

Empagliflozin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

InCor

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Disease; Arrhythmias, Cardiac; Diabetes Mellitus

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bruno Caramelli, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor of Medicine

Model Details: Patient data will be compared before and after treatment

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: October 4, 2019
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)