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

NCT ID: NCT05029115

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 716 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-05
• Study Completion Date: 2026-12-31

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.

Conditions

SGLT-2 Inhibitor; Atrial Fibrillation; Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

SGLT-2 inhibitor administration group

The group who administrated SGLT-2 inhibitor for hypoglycemic medication

SGLT2 inhibitor

Intervention Type: DRUG

Dapagliflozin, Empagliflozin

control

The group who are not administrated SGLT-2 inhibitor

No interventions assigned to this group

Interventions

SGLT2 inhibitor

Dapagliflozin, Empagliflozin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ewha Womans University Mokdong Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sumi Jung

Role: STUDY_DIRECTOR

Ewha Womans University Mokdong Hospital

Locations

Ewha womans university mokdong hospital

Yangcheon, Seoul, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 36652465 (View on PubMed)

Other Identifiers

BEYOND trial

Identifier Type: -

Identifier Source: org_study_id