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

NCT06721442 | Completed Phase 4

• 1 other identifier: DAPA-ECG
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 2

Brief 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

Arrhythmias, Cardiac; Diabetes Mellitus

Keywords

Type 2 Diabetes Cardiac Arrhythmias; Dapagliflozin; Ventricular Repolarization; Electrocardiogram; Cardiac Arrhythmias

Outcome Measures

Primary Outcomes (1)

• Effect of Dapagliflozin on the TpeakTend Interval

  In the intervention group (dapagliflozin), 12-lead electrocardiograms (ECGs) were performed during designated outpatient visits, with the initial baseline recording conducted at visit 1 (day 0) and the subsequent recording at the final visit, approximately 90 days after the study began. The ECGs were obtained using Micromed electronic equipment, configured with a paper speed of 25 mm/s and an amplitude of 10 mm/mV, ensuring standardized measurements. The ECG intervals were manually measured using Wincardio software (version 11.1.0.0). The primary outcome, the interval between the peak of the T wave and the end of the T wave (TpTe), was assessed to evaluate the effect of dapagliflozin. This assessment compared the two time points (baseline and follow-up), with all ECGs analyzed by an independent external examiner to ensure objectivity and reliability of the study results.

  90 days

Secondary Outcomes (6)

• Effect of Dapagliflozin on the QT and QTc Interval

  90 days

• Effect of Dapagliflozin on the TpTe/QT ratio

  90 days

• Effect of Dapagliflozin on the J-Tpeak Interval

  90 days

• Effect of Dapagliflozin on the QT interval dispersion (QTd)

  90 days

• Effect of Dapagliflozin on The QRS-T angle

  90 days

Other Outcomes (13)

• Glycated hemoglobin (HbA1c)

  90 days

• Weight

  90 days

• Body Mass Index (BMI)

  90 days

Study Arms (2)

Dapafliflozin

ACTIVE COMPARATOR

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.

Drug: Dapagliflozin (DAPA)

Control group

NO INTERVENTION

A total of 174 individuals were assessed for eligibility, and 87 were randomized to continue receiving optimized medical treatment for type 2 diabetes.

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.

Also known as: iSGLT2, SGLT2 inhibitor

Dapafliflozin

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• Patients with a QRS interval \> 120 ms;
• Insulin use;
• Atrial fibrillation rhythm;
• Cardiac pacemaker rhythm;
• Planned cardiac surgery or angioplasty within 3 months;
• 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;
• Medicinal treatment for weight loss within 3 months of the study start;
• Pregnant women, women with delayed menstruation, or those breastfeeding.

Sponsors & Collaborators

• Beneficência Portuguesa de São Paulo: lead
• Instituto Dante Pazzanese de Cardiologia: collaborator

Study Sites (2)

Hospital Beneficencia Portuguesa de São Paulo

São Paulo, São Paulo, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

• Campos RN, Moreira DAR, Fonseca GM. Effect of dapagliflozin, a sodium-glucose co-transporter 2 inhibitor, on ventricular repolarization electrocardiographic parameters in type 2 diabetes patients: DAPA - ECG study. Front Clin Diabetes Healthc. 2025 Mar 31;6:1537005. doi: 10.3389/fcdhc.2025.1537005. eCollection 2025.

  PMID: 40230406 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac; Diabetes Mellitus

Interventions

dapagliflozin; Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All eligible patients were randomized into two groups using the REDCap software: one group received dapagliflozin combined with optimized medical treatment, while the other group received only the optimized treatment. Each group included 87 patients. To minimize bias in the open-label design, electrocardiograms performed at baseline and at the final visit were evaluated by external independent examiners blinded to group allocation. The Kappa index was used to ensure data consistency and reliability. These measures provided greater rigor and validity to the study results.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor-cardiologist

Model Details: Multicenter, randomized, open-label, controlled trial

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 6, 2024
• Study Start: January 10, 2023
• Primary Completion: December 10, 2023
• Study Completion: July 10, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)