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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05029115
Other study ID # BEYOND trial
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 5, 2021
Est. completion date December 2026

Study information

Verified date January 2023
Source Ewha Womans University Mokdong Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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 information / eligibility

Status Enrolling by invitation
Enrollment 716
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
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

Study Design


Intervention

Drug:
SGLT2 inhibitor
Dapagliflozin, Empagliflozin

Locations

Country Name City State
Korea, Republic of Ewha womans university mokdong hospital Yangcheon Seoul

Sponsors (1)

Lead Sponsor Collaborator
Ewha Womans University Mokdong Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary 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
Secondary Atrial fibrillation burden 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
Secondary Ablation rate percentage of patients undergone ablation within a year 1 year
Secondary 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
Secondary Diameter of left atrium mm, measuring by transthoracic echocardiography difference between the time of enrollment and the time after 1 year
Secondary NT-proBNP pg/mL difference between the time of enrollment and the time after 1 year
Secondary 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
Secondary 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
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