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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05029115
• Other study ID #: BEYOND trial
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

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