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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGLT-2 inhibitor administration group | The group who administrated SGLT-2 inhibitor for hypoglycemic medication |
| |
| control | The group who are not administrated SGLT-2 inhibitor |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGLT2 inhibitor | Drug | Dapagliflozin, Empagliflozin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from enrollment to recurrence |
| Atrial fibrillation burden |
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Inclusion Criteria:
Exclusion Criteria:
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The patients who diagnosed AF and T2DM in one year
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| Name | Affiliation | Role |
|---|---|---|
| Sumi Jung | Ewha Womans University Mokdong Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewha womans university mokdong hospital | Yangcheon | Seoul | 07985 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36652465 | Derived | Lee K, Lee SK, Lee J, Jeon BK, Kim TH, Yu HT, Lee JM, Park JK, Baek YS, Kim DH, Shim J, Joung B, Lee MH, Pak HN, Park J. Protocol of BEYOND trial: Clinical BEnefit of sodium-glucose cotransporter-2 (SGLT-2) inhibitors in rhYthm cONtrol of atrial fibrillation in patients with diabetes mellitus. PLoS One. 2023 Jan 18;18(1):e0280359. doi: 10.1371/journal.pone.0280359. eCollection 2023. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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AF burden is defined as atrial fibrillation time percentage documented on 24-hour Holter ECG
| at the enrollment and 3, 6, 9 and 12 months after enrollment |
| Ablation rate | percentage of patients undergone ablation within a year | 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 | at the enrollment and 3, 6, 9 and 12 months after enrollment |
| Diameter of left atrium | mm, measuring by transthoracic echocardiography | difference between the time of enrollment and the time after 1 year |
| NT-proBNP | pg/mL | 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. | 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. | at the enrollment and after 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D045505 | Physiological Effects of Drugs |