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Atrial FibrillationPhase 4ENAVO-AFNCT06528262

Effect of Enavogliflozin on Recurrence of Atrial Fibrillation After Catheter Ablation

A Phase 4 study testing Enavogliflozin in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 19 to 84 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
Enavogliflozin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
390 participants
Where
1 siteSouth Korea
Study dates
3 Apr 2025to 31 May 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 19 to under 85
  • Patients who consent to participate in the study and can be followed up during the study
  • 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

Who cannot join

  • Under 19 or over 85 years old
  • Patients who have participated in another clinical trial within the last three months
  • Life expectancy of less than one year
  • Pregnant or breastfeeding women
  • Currently being treated with an SGLT-2 inhibitor
  • Three or more urinary or genital infections within the last year
Show all 19Show fewer
  • Uncontrolled hypertension: systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 110mmHg
  • Systolic blood pressure < 90mmHg
  • Acute cardiovascular event within the last 12 weeks
  • Severe valvular disease or presence of artificial valves
  • Renal impairment (eGFR CKD-EPI < 60 ml/min/1.73m²)
  • Clinically confirmed liver dysfunction
  • Uncontrolled thyroid dysfunction
  • 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.
  • Continuous use of oral prednisolone at 10mg/day or equivalent, or higher doses of steroids, within the last month
  • Patients with hypersensitivity or history of hypersensitivity to the active or inactive ingredients of this drug
  • Patients with type 1 diabetes or diabetic ketoacidosis
  • History of alcohol or substance abuse
  • Women of childbearing potential who do not agree to use adequate contraception during the clinical trial period

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site, 1 recruiting
  • Severance Hospital

    Seoul

    Yong-ho Lee, Ph.D., 82-2-2228-1943, yholee@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

Official title: 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

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.

Read the detailed description

Study Design Overview:

  • Single-center, prospective, randomized controlled, double-blind study.
  • Patients who consent will be randomly assigned to either the intervention or control group.
  • The intervention group will receive Enavogliflozin 0.3 mg once daily. The control group will receive a placebo in the same form.
  • The administration period will be 360±30 days, targeting patients hospitalized for AF catheter ablation at Severance Hospital or those who have undergone the procedure within the past three months.
  • Target participants: 195 in the experimental group (SGLT2 inhibitor group), 195 in the control group (placebo group), totaling 390 participants.
  • Regular standard ECG examinations will be conducted at 1, 3, 6, and 12 months post-procedure, and as needed based on symptoms.
  • Wearable ECG patch (8-14 days) tests will be conducted at 3, 6, and 12 months follow-up visits.
  • Comparison of AF recurrence rates from 3 months to 1 year post-catheter ablation.
  • Comparison of AF burden from catheter ablation up to 1 year post-procedure.
Being tested
Enavogliflozin, Placebo
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnavogliflozinDrug

    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

  • PlaceboDrug

    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

Study groups in NCT06528262
Study groupRoleWhat they receive
EnavogliflozinExperimentalEnavogliflozin as a study group
Receives: Drug: Enavogliflozin
PlaceboPlacebo comparatorPlacebo as a comparison group
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months after catheter ablation

Secondary outcomes (7)
  1. 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

    Measured: At 3, 6, 12 months after catheter ablation

  2. 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

    Measured: 12 months after catheter ablation

  3. Difference in the heart failure hospitalization rate after catheter ablation between the experimental group (enavogliflozin group) and the control group (placebo group)

    Measured: 12 months after catheter ablation

  4. The group difference in the AF symptom score (mEHRA) between baseline and 12 months after catheter ablation with enavogliflozin or placebo

    Measured: Baseline and 12 months after catheter ablation

  5. 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

    Measured: Baseline and 12 months after catheter ablation

  6. The group difference in serum NT-proBNP levels between baseline and 12 months after catheter ablation with enavogliflozin or placebo

    Measured: Baseline and 12 months after catheter ablation

  7. 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)

    Measured: 12 months after catheter ablation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2024
  2. Study start3 Apr 2025
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
390 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06528262
Sponsor's protocol ID
4-2024-0511
Acronym
ENAVO-AF
Status last verified
May 2026
First submitted
25 Jul 2024
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Enavogliflozin in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 12 months after catheter ablation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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