A Phase 4 interventional study of Enavogliflozin and Placebo in Atrial Fibrillation, sponsored by Yonsei University. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Yonsei University · Phase 4, Interventional, and Treatment
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. Catheter ablation for rhythm control significantly reduces AF recurrence compared to antiarrhythmic drugs, leading to more patients undergoing this procedure. AF and heart failure often coexist, forming a vicious cycle that exacerbates both conditions and leads to poorer outcomes. They share common risk factors like hypertension, diabetes, ischemic heart disease, and valvular disease. Heart failure increases left atrial filling pressure and alters intracellular calcium levels, raising AF risk. Further research is needed on their pathophysiological link. SGLT2 inhibitors reduce glucose reabsorption in the kidneys to control hyperglycemia in diabetics and have been shown in large studies (DAPA-HF, EMPEROR-Reduced) to significantly reduce heart failure worsening and cardiovascular mortality, regardless of diabetes status. These benefits were seen in both HFrEF and HFpEF. In the DAPA-HF trial, 55% of participants were non-diabetic, and reductions in heart failure worsening or cardiovascular death were similar between those with and without diabetes (25% vs. 27%). Adverse events, including volume depletion and renal function decline, were not significantly different between diabetic and non-diabetic patients, and no hypoglycemia or ketoacidosis occurred in non-diabetic patients. Recent studies show SGLT2 inhibitors reduce AF incidence and benefit heart failure. A sub-analysis of the DECLARE-TIMI 58 trial reported a 19% reduction in AF risk among diabetic patients with SGLT2 inhibitors. Meta-analyses by Okunrintemi and Zheng showed an 18% reduction in AF risk irrespective of diabetes status. Interest is growing in the relationship between SGLT2 inhibitors and AF recurrence post-catheter ablation. Luo et al. reported a nearly 39% reduction in AF recurrence post-ablation with dapagliflozin in diabetic patients. Kishima et al. found a 49% reduction in AF recurrence post-ablation with SGLT2 inhibitors versus DPP-IV inhibitors in a small prospective randomized study. However, most studies were retrospective, sub-analyses, or small-scale studies limited to diabetics. Prospective randomized studies involving AF patients regardless of diabetes status are urgently needed for validation.
Study Design Overview:
3,870 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's planned enrollment of 390 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
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Exclusion Criteria:
Enavogliflozin as a study group
Drug: Enavogliflozin
Placebo as a comparison group
Drug: Placebo
Patients hospitalized at Severance Hospital for atrial fibrillation catheter ablation, or those who had the procedure within the last three months, will be randomly assigned to receive either 0.3 mg of enavogliflozin once daily or a placebo for 360±30 days
Patients hospitalized at Severance Hospital for atrial fibrillation catheter ablation, or those who had the procedure within the last three months, will be randomly assigned to receive either 0.3 mg of enavogliflozin once daily or a placebo for 360±30 days
Difference in the recurrence rate of atrial fibrillation (AF) between the experimental group (enavogliflozin group) and the control group (placebo group) from 3 months to 1 year after catheter ablation
In subjects who have completed 12 months of follow-up or experienced AF recurrence, the difference in AF recurrence rates between the enavogliflozin group and the placebo group from 3 months to 1 year after catheter ablation will be investigated. AF recurrence is defined as atrial tachycardia/flutter/fibrillation lasting more than 30 seconds, as confirmed by ECG or Holter monitoring. Recurrences within the first 3 months post-procedure are considered part of the blanking period and are not included in the evaluation.
Time frame: 12 months after catheter ablation
Difference in total AF burden (%) confirmed by Holter (wearable patch ECG) monitoring between the experimental group (enavogliflozin group) and the control group (placebo group) from 3 months to 1 year after catheter ablation
Definition of total AF burden (%): Duration of the longest AF episode Number of AF episodes/total Holter monitoring period Time in AF/total Holter monitoring period
Time frame: At 3, 6, 12 months after catheter ablation
Difference in time to first AF recurrence between the experimental group (enavogliflozin group) and the control group (placebo group) from 3 months to 1 year after catheter ablation
Time frame: 12 months after catheter ablation
Difference in the heart failure hospitalization rate after catheter ablation between the experimental group (enavogliflozin group) and the control group (placebo group)
Time frame: 12 months after catheter ablation
The group difference in the AF symptom score (mEHRA) between baseline and 12 months after catheter ablation with enavogliflozin or placebo
Time frame: Baseline and 12 months after catheter ablation
The group difference in metabolic parameters, including glycated hemoglobin (HbA1c), body weight, insulin resistance (HOMA-IR), ketone bodies, and fatty liver index, between baseline and 12 months after catheter ablation with enavogliflozin or placebo
Time frame: Baseline and 12 months after catheter ablation
The group difference in serum NT-proBNP levels between baseline and 12 months after catheter ablation with enavogliflozin or placebo
Time frame: Baseline and 12 months after catheter ablation
Difference in adverse events, including hypoglycemia, diabetic ketoacidosis, and genitourinary infection rates, after catheter ablation between the experimental group (enavogliflozin group) and the control group (placebo group)
Time frame: 12 months after catheter ablation
Plan to share: No
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Yonsei University