NCT06721442CompletedPhase 4
Effect of Dapagliflozin on Electrocardiographic Parameters in Type 2 Diabetes Patients: DAPA - ECG Study
Effect of Dapagliflozin, a Sodium-Glucose Co-Transporter 2 Inhibitor, on Ventricular Repolarization Electrocardiographic Parameters in Type 2 Diabetes Patients: DAPA - ECG Study
Source: ClinicalTrials.gov · Last updated 6 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 174 (actual)
- First submitted
- 27 Nov 2024
- Start date
- 10 Jan 2023
- Primary completion date
- 10 Dec 2023
- Lead sponsor
- Beneficência Portuguesa de São Paulo
- Diseases
- Type 2 diabetes
- NCT number
- NCT06721442
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 174
- From 10 Jan 2023 to the primary completion date, 10 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cardiac pacemaker rhythm;
- Planned cardiac surgery or angioplasty within 3 months;
Lab values
- Glycemic control issues (glucose \> 240 mg/dL) after an overnight fast of 8 hours in both groups;
- Liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 times the upper limit of normal during the baseline phase;
Other
- Patients with a QRS interval \> 120 ms;
- Insulin use;
- Atrial fibrillation rhythm;
- Medicinal treatment for weight loss within 3 months of the study start;
- Pregnant women, women with delayed menstruation, or those breastfeeding.
Who the study is looking for
- Adult patients (≥18 years old);
- Resting 12-lead electrocardiogram in sinus rhythm;
- Type 2 diabetes;
- Body mass index (BMI), calculated as weight in kilograms divided by height in meters squared, of 45 or less;
- Estimated glomerular filtration rate (eGFR) of at least 30 ml per minute per 1.73 m² of body surface area, according to CKD-EPI criteria;
- Agreed to participate in the study and signed the informed consent form (ICF).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Dante Pazzanese de Cardiologia Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital Beneficência Portuguesa de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.