Enavogliflozin to reduce AF coming back after catheter ablation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, double-blind, placebo-controlled trial enrolling about 390 patients who have atrial fibrillation and heart failure and are undergoing or recently underwent catheter ablation. Participants will be assigned to enavogliflozin 0.3 mg once daily or matching placebo for approximately 360 days with regular follow-up visits. Standard 12-lead ECGs will be done at 1, 3, 6, and 12 months and wearable ECG patch monitoring (8–14 days) at 3, 6, and 12 months to measure AF recurrence and AF burden. The main comparisons are AF recurrence between months 3 and 12 and overall AF burden up to one year after ablation.

Why it matters

Who can join: the full rules

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

Where it's running

• Severance Hospital
  Seoul, South Korea Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.