The Effect of SGLT-2 Inhibitor in Patient With Atrial Fibrillation and Diabetes Mellitus

This study is a multicenter, prospective open blinded-endpoint design, 1:1 randomized, and controlled study, with total of 716 patients enrolled from 4-5 centers. The primary outcome is recurrence rate of atrial fibrillation within a year, when recurrence of atrial fibrillation is defined as at least one significant atrial fibrillation documented on 24-hour Holter ECG. Secondary outcomes are atrial fibrillation free survival, atrial fibrillation burden at various time points, ablation rate within a year, atrial fibrillation recurrence rate after ablation within a year, volume of left atrium, NT-ProBNP, Symptom score and Quality of Life.

Inclusion criteria

• At least one episode of atrial fibrillation* that is documented during the prior year by any kind of ECG recording.
• Diabetes mellitus type II was diagnosed. (HBA1c >6.5%) and are using oral hypoglycemic agents only
• At least 20 years old and not older than 80 years old.
• Normal ECG parameters when measured in sinus rhythm (QRS width ≤120 ms, QTc interval <440 ms, and PQ interval ≤210 ms in a 12 lead ECG)
• Able and willing to give informed consent.

Exclusion criteria

• Any disease that limits life expectancy under 1 year
• Subject for another clinical trial within the past 2 months
• Under 20 years old or over 80 years old
• Pregnant women
• Lactating women
• Drug abuser
• Type 2 DM treated by recombinant insulin
• Diagnosis of Type 1 DM, MODY, or secondary DM
• HbA1c ≥12% or HbA1c <6.5% at diagnosis
• Previous treatment with any SGLT2 inhibitor
• Renal dysfunction (eGFR-CKD-EPI <30ml/min/1.73m^2)
• Chronic cystitis and/or recurrent genitourinary tract infections (3 or more in the last year)
• Unexplained hematuria at baseline study
• Systolic BP >180mmHg or diastolic BP >100mmHg at baseline study
• Systolic BP <95mmHg at baseline study
• Previous treatment with AF ablation
• Acute cardiovascular event [e.g., stroke, acute coronary syndrome (ACS), revascularization, decompensated HF, sustained ventricular tachycardia, return of spontaneous circulation (ROSC)] <8 weeks prior to baseline study
• Severe valvular disease or have prosthetic valve
• Treatment with chronic oral steroid (>30 consecutive days) at a dose equivalent to oral prednisolone ≥10mg/d, within the past 1 month
• History of any malignancy within 5 years
• Clinically profound hepatic dysfunction
• Clinically uncontrolled thyroid dysfunction
• Patients incapable of completing the trial due to any severe medical condition by clinical decision
• Patients with poor compliance (defined as 80 - 120%), except for reasonable situations judged by physician