Enavogliflozin to reduce AF coming back after catheter ablation
ENavogliflozin And preVention Of Atrial Fibrillation Recurrence After Catheter Ablation for Atrial Fibrillation With Heart Failure (ENAVO-AF): Prospective, Multicenter, Randomized, Placebo-controlled Double-blind Clinical Trial
This will test whether taking the SGLT2 inhibitor enavogliflozin for about a year helps people with atrial fibrillation and heart failure who have had catheter ablation have fewer AF recurrences than a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 19 Years to 84 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06528262 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 19 to under 85 with atrial fibrillation and heart failure who are scheduled for or within three months after AF catheter ablation, can attend follow-up at the study center, have adequate kidney function (eGFR ≥ 60) and are not currently using an SGLT2 inhibitor are ideal candidates.
Not a fit: Patients with significant renal impairment (eGFR < 60), recent acute cardiovascular events, severe valvular disease or artificial valves, current SGLT2 inhibitor treatment, pregnancy, or those outside the age range are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could lower the rate of AF coming back after ablation and reduce AF burden, symptoms, and related healthcare visits.
How similar studies have performed: SGLT2 inhibitors have shown benefits in heart failure and some observational links to lower AF incidence, but randomized evidence specifically showing prevention of AF recurrence after ablation is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul
- Severance Hospital — Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.