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

Sponsor
Beneficência Portuguesa de São Paulo
Study ID
NCT06721442
Phase
PHASE4
Status
Completed

Conditions

  • Arrhythmias, Cardiac
  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin (DAPA) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 10, 2023
Status verified
Dec 2024
Primary completion
Dec 10, 2023
Completion
Jul 10, 2024

Study Design

Enrollment
174 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Dapafliflozin
    A total of 174 individuals were assessed for eligibility, of whom 87 were randomized to receive dapagliflozin in combination with optimized medical treatment for type 2 diabetes.
  • No Intervention: Control group
    A total of 174 individuals were assessed for eligibility, and 87 were randomized to continue receiving optimized medical treatment for type 2 diabetes.

Primary Outcome Measure

Effect of Dapagliflozin on the TpeakTend Interval [ Time Frame: 90 days ]

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