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Набор по приглашению NCT05029115

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

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: SGLT2 inhibitor.
Кому может быть актуально
Состояния в реестре: SGLT-2 Inhibitor, Atrial Fibrillation, Diabetes Mellitus, Type 2. Базовые параметры: 20 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

  • Препарат SGLT2 inhibitor
    Dapagliflozin, Empagliflozin

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

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

Публикации

  • 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

Идентификаторы

NCT: NCT05029115 · BEYOND trial

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗