This study was designed to compare the effects on atrial rhythm control between SGLT2 inhibitor and other oral hypoglycemic agents in patients with atrial fibrillation and diabetes mellitus. We are to compare efficacy and safety between these two groups.
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.
Study Type
OBSERVATIONAL
Enrollment
716
Dapagliflozin, Empagliflozin
Ewha womans university mokdong hospital
Yangcheon, Seoul, South Korea
recurrence rate of AF within a year in all participants
Recurrence rates of AF after stepwise rhythm control therapies including anti-arrhythmic drugs (AAD) and ablation.
Time frame: during 1 year
recurrence rate of AF within a year in ablated participants
Recurrence rates of AF after stepwise rhythm control therapies including anti-arrhythmic drugs (AAD) and ablation.
Time frame: 1 year
Atrial fibrillation free survival
will be compared between two groups as the first of the secondary outcome, analyzed with Kaplan-Meier method and documented on curve
Time frame: from enrollment to recurrence
Atrial fibrillation burden
AF burden is defined as atrial fibrillation time percentage documented on 24-hour Holter ECG
Time frame: at the enrollment and 3, 6, 9 and 12 months after enrollment
Ablation rate
percentage of patients undergone ablation within a year
Time frame: 1 year
Sinus rhythm maintenance rate
Sinus rhythm is considered stable when either a standard ECG or a 24-hour Holter ECG showed no episode of clinically relevant arrhythmia, including AF, at the time of check-up
Time frame: at the enrollment and 3, 6, 9 and 12 months after enrollment
Diameter of left atrium
mm, measuring by transthoracic echocardiography
Time frame: difference between the time of enrollment and the time after 1 year
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NT-proBNP
pg/mL
Time frame: difference between the time of enrollment and the time after 1 year
mEHRA (modified European Heart Rhythm Association) symptom score
1, 2a, 2b, 3 and 4. High score means high AF severity.
Time frame: at the enrollment and 3, 6, 9 and 12 months after enrollment
Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) score
consisted of 20 questions. Lower AFEQT score means high AF severity.
Time frame: at the enrollment and after 1 year