Effect of Dapagliflozin on Electrocardiographic Parameters in Type 2 Diabetes Patients: DAPA - ECG 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.
Timeline
- Start
- 2023-01-10
- Primary completion
- 2023-12-10
- Completion
- 2024-07-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dapagliflozin | Small molecule | 10 mg | — |