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

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
SGLT-2 inhibitor administration group	SGLT2 inhibitor	The group who administrated SGLT-2 inhibitor for hypoglycemic medication

Primary Outcome Measures

Name	Time	Method
recurrence rate of AF within a year in all participants	during 1 year	Recurrence rates of AF after stepwise rhythm control therapies including anti-arrhythmic drugs (AAD) and ablation.
recurrence rate of AF within a year in ablated participants	1 year	Recurrence rates of AF after stepwise rhythm control therapies including anti-arrhythmic drugs (AAD) and ablation.

Secondary Outcome Measures

Name	Time	Method
Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) score	at the enrollment and after 1 year	consisted of 20 questions. Lower AFEQT score means high AF severity.
Sinus rhythm maintenance rate	at the enrollment and 3, 6, 9 and 12 months after enrollment	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
Atrial fibrillation free survival	from enrollment to recurrence	will be compared between two groups as the first of the secondary outcome, analyzed with Kaplan-Meier method and documented on curve
Diameter of left atrium	difference between the time of enrollment and the time after 1 year	mm, measuring by transthoracic echocardiography
NT-proBNP	difference between the time of enrollment and the time after 1 year	pg/mL
mEHRA (modified European Heart Rhythm Association) symptom score	at the enrollment and 3, 6, 9 and 12 months after enrollment	1, 2a, 2b, 3 and 4. High score means high AF severity.
Atrial fibrillation burden	at the enrollment and 3, 6, 9 and 12 months after enrollment	AF burden is defined as atrial fibrillation time percentage documented on 24-hour Holter ECG
Ablation rate	1 year	percentage of patients undergone ablation within a year

Locations (1): Ewha womans university mokdong hospital
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Yangcheon, Seoul, Korea, Republic of