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

NCT05029115 | Enrolling By Invitation DMC

• 1 other identifier: BEYOND trial
• Study Type: observational
• Target: 716
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• Atrial fibrillation free survival

  from enrollment to recurrence

• Atrial fibrillation burden

  at the enrollment and 3, 6, 9 and 12 months after enrollment

• Ablation rate

  1 year

• Sinus rhythm maintenance rate

  at the enrollment and 3, 6, 9 and 12 months after enrollment

• Diameter of left atrium

  difference between the time of enrollment and the time after 1 year

Study Arms (2)

SGLT-2 inhibitor administration group

The group who administrated SGLT-2 inhibitor for hypoglycemic medication

Drug: SGLT2 inhibitor

control

The group who are not administrated SGLT-2 inhibitor

Interventions

SGLT2 inhibitor DRUG

Dapagliflozin, Empagliflozin

SGLT-2 inhibitor administration group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients who diagnosed AF and T2DM in one year

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ewha Womans University Mokdong Hospital: lead

Study Sites (1)

Ewha womans university mokdong hospital

Yangcheon, Seoul, 07985, South Korea

Location

Related Publications (1)

• 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.

  PMID: 36652465 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Diabetes Mellitus, Type 2

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Sumi Jung

  Ewha Womans University Mokdong Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: August 31, 2021
• Study Start: October 5, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

KR (1)