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Effect of Enavogliflozin on Recurrence of Atrial Fibrillation After Catheter Ablation

RecruitingPhase 4Ages 19 Years - 84 YearsAllYonsei University
NCT06528262 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Objective: The purpose of this study is to determine if there is a difference in the recurrence rate of atrial fibrillation (AF) between a group of patients with AF and heart failure undergoing catheter ablation who are administered the SGLT2 inhibitor, Enavogliflozin, and a control group (placebo group). This study aims to investigate whether SGLT2 inhibitors can prevent the recurrence of AF after the procedure. Background: AF is the most common arrhythmia requiring treatment, with its prevalence increasing with age. In the US, AF affected 5.2 million people in 2010 and is projected to reach 12.1 million by 2030. In South Korea, prevalence rose from 0.73% in 2006 to 1.53% in 2015. Early-stage AF patients benefit more from rhythm control therapy than from heart rate control alone, as shown by the 2020 EAST-AFNET-4 trial, which reported a 21% reduction in adverse cardiovascular events. C

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adults aged 19 to under 85 2. Patients who consent to participate in the study and can be followed up during the study 3. Patients with AF and heart failure who have undergone atrial fibrillation catheter ablation within the last three months or are scheduled to undergo the procedure Exclusion Criteria: 1. Under 19 or over 85 years old 2. Patients who have participated in another clinical trial within the last three months 3. Life expectancy of less than one year 4. Pregnant or breastfeeding women 5. Currently being treated with an SGLT-2 inhibitor 6. Three or more urinary or genital infections within the last year 7. Uncontrolled hypertension: systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 110mmHg 8. Systolic blood pressure \< 90mmHg 9. Acute cardiovascular event within the last 12 weeks 10. Severe valvular disease or presence of artificial valves 11. Renal impairment (eGFR CKD-EPI \< 60 ml/min/1.73m²) 12. Clinically confirmed liver dysfunction 13. Uncontrolled thyroid dysfunction 14. Patients with active cancer (including those undergoing treatment) or history of cancer within the last five years at the time of screening; however, borderline cancers are not excluded if successfully treated and recurrence-free for 2-3 years. 15. Continuous use of oral prednisolone at 10mg/day or equivalent, or higher doses of steroids, within the last month 16. Patients with hypersensitivity or history of hypersensitivity to the active or inactive ingredients of this drug 17. Patients with type 1 diabetes or diabetic ketoacidosis 18. History of alcohol or substance abuse 19. Women of childbearing potential who do not agree to use adequate contraception during the clinical trial period
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What it tests

  • Enavogliflozin
  • Placebo
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Where

1 site
Severance Hospital
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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