MedTrace Logo

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

NCT06721442 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2024-12-06

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate whether dapagliflozin can reduce ventricular electrical remodeling, as measured by electrocardiographic parameters, in patients with type 2 diabetes (T2D). The study focuses on understanding how dapagliflozin affects the risk of potentially malignant ventricular arrhythmias and sudden cardiac death in this population.

The main questions it aims to answer are:

* Does dapagliflozin reduce the TpTe interval in patients with T2D?
* Does dapagliflozin impact other electrocardiographic parameters such as QT and QTc intervals, TpTe/QT ratio, and QT dispersion?

Researchers will compare patients treated with dapagliflozin plus optimized medical therapy (OMT) o those receiving OMT without SGLT2 inhibitors to assess whether there is a significant difference in the electrocardiographic parameters and ventricular electrical remodeling.

Participants will:

Be randomized into two groups: one treated with dapagliflozin and the other with optimized medical therapy.

Undergo clinical, electrocardiographic, laboratory, and echocardiographic evaluations at baseline and after three months.

This randomized, prospective, multicenter, open-label study seeks to clarify the cardioprotective mechanisms of dapagliflozin, particularly its impact on ventricular electrical remodeling in patients with type 2 diabetes.

Conditions

Interventions

DRUG

Dapagliflozin (DAPA)

Patients randomized to receive a daily dose of 10 milligrams of dapagliflozin were evaluated to assess the medication's impact on electrocardiographic parameters of repolarization, with focus on its potential to reduce ventricular repolarization prolongation in individuals with type 2 diabetes.

Sponsors & Collaborators

  • Instituto Dante Pazzanese de Cardiologia

    collaborator OTHER

  • Beneficência Portuguesa de São Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2023-12-10
Completion
2024-07-10

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06721442 on ClinicalTrials.gov