Atrial Fibrillation, Diabetes Mellitus, Type 2, SGLT-2 Inhibitor
Conditions
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.
Interventions
DRUGSGLT2 inhibitor
Dapagliflozin, Empagliflozin
Sponsors
Ewha Womans University Mokdong Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Ablation rate | 1 year | percentage of patients undergone ablation within a year |
| 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 |
| Diameter of left atrium | difference between the time of enrollment and the time after 1 year | mm, measuring by transthoracic echocardiography |
| 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 |
| 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 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. |
| NT-proBNP | difference between the time of enrollment and the time after 1 year | pg/mL |
| 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 |
Countries
South Korea
Outcome results
None listed