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Enrolling by invitation NCT05029115

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

— Observational SGLT-2 Inhibitor Atrial Fibrillation Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SGLT2 inhibitor.
Who it may be relevant to
Registry conditions: SGLT-2 Inhibitor, Atrial Fibrillation, Diabetes Mellitus, Type 2. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug SGLT2 inhibitor
    Dapagliflozin, Empagliflozin

Primary outcome measures

  • recurrence rate of AF within a year in all participants [Time frame: during 1 year]
  • recurrence rate of AF within a year in ablated participants [Time frame: 1 year]
Secondary outcome measures (8)
  • Atrial fibrillation free survival [Time frame: from enrollment to recurrence]
  • Atrial fibrillation burden [Time frame: at the enrollment and 3, 6, 9 and 12 months after enrollment]
  • Ablation rate [Time frame: 1 year]
  • Sinus rhythm maintenance rate [Time frame: at the enrollment and 3, 6, 9 and 12 months after enrollment]
  • Diameter of left atrium [Time frame: difference between the time of enrollment and the time after 1 year]
  • NT-proBNP [Time frame: difference between the time of enrollment and the time after 1 year]
  • mEHRA (modified European Heart Rhythm Association) symptom score [Time frame: at the enrollment and 3, 6, 9 and 12 months after enrollment]
  • Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) score [Time frame: at the enrollment and after 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

South Korea · 1 center
  • Ewha womans university mokdong hospital — Yangcheon

Publications

  • 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

Identifiers

NCT: NCT05029115 · BEYOND trial

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗