Clinical Impact of SGLT2 Inhibitor After DC Cardioversion in Persistent AF With HFpEF

August 17, 2026 updated by: Juwon Kim, Samsung Medical Center

Clinical Impact of SGLT2 Inhibitor After DC Cardioversion in Persistent Atrial Fibrillation Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Controlled Trial

SGLT2 inhibitors improve outcomes in heart failure across the ejection fraction spectrum, but their effect on maintenance of sinus rhythm after rhythm-control therapy is largely unknown. This prospective, single-center, open-label randomized controlled trial evaluates whether an SGLT2 inhibitor started after successful electrical cardioversion reduces recurrence of atrial tachyarrhythmia at 1 month in patients with persistent atrial fibrillation and heart failure with preserved ejection fraction. 200 patients will be randomized 1:1 to receive an SGLT2 inhibitor or no SGLT2 inhibitor.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with persistent atrial fibrillation who meet HFpEF diagnostic criteria (H2FPEF ≥6 or HFA-PEFF ≥5) are screened. After at least 4 weeks of anticoagulation and exclusion of intracardiac thrombus by transesophageal echocardiography, electrical cardioversion is performed with a biphasic defibrillator. Patients who restore sinus rhythm and provide written informed consent are randomized 1:1, stratified by AF duration and left atrial size. All patients receive anticoagulation and antiarrhythmic drugs for 1 month per current guidelines, at the discretion of the treating physician. The primary endpoint is recurrence of atrial tachyarrhythmia at 1 month, assessed by 12-lead ECG or continuous monitoring (≥30 seconds). Analyses follow the intention-to-treat principle, with per-protocol analysis as a sensitivity analysis. The sample size of 200 provides approximately 90% power at a two-sided alpha of 0.05 to detect a difference in recurrence (24% vs 47%).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥19 years
  • Persistent atrial fibrillation
  • H2FPEF score ≥6 or HFA-PEFF score ≥5
  • Restoration of sinus rhythm after electrical cardioversion

Exclusion Criteria:

  • Previous use of an SGLT2 inhibitor
  • Intracardiac thrombus on transesophageal echocardiography
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SGLT2 inihibitor
Patients receive an SGLT2 inhibitor (empagliflozin or dapagliflozin) after successful DC cardioversion, in addition to guideline-directed anticoagulation and antiarrhythmic drugs for 1 month.
Drug: SGLT2 inhibitors (Dapagliflozin and Empagliflozin)
Patients receive an SGLT2 inhibitor (empagliflozin or dapagliflozin) after successful DC cardioversion, in addition to guideline-directed anticoagulation and antiarrhythmic drugs for 1 month.
No Intervention: Control
Patients receive guideline-directed anticoagulation and antiarrhythmic drugs after DC cardioversion, without an SGLT2 inhibitor.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recurrence of atrial tachyarrhythmia
Time Frame: 1 month after randomization (±1 week)
Composite of atrial fibrillation, atrial flutter, and atrial tachycardia, documented on 12-lead ECG or as an episode lasting ≥30 seconds on continuous ECG monitoring.
1 month after randomization (±1 week)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recurrence of atrial fibrillation
Time Frame: 1 month after randomization (±1 week)
atrial fibrillation documented on 12-lead ECG or as an episode lasting ≥30 seconds on continuous ECG monitoring.
1 month after randomization (±1 week)
Recurrence of atrial flutter
Time Frame: 1 month after randomization (±1 week)
atrial flutter documented on 12-lead ECG or as an episode lasting ≥30 seconds on continuous ECG monitoring.
1 month after randomization (±1 week)
Recurrence of atrial tachycardia
Time Frame: 1 month after randomization (±1 week)
atrial tachycardia documented on 12-lead ECG or as an episode lasting ≥30 seconds on continuous ECG monitoring.
1 month after randomization (±1 week)
Stroke
Time Frame: 1 month after randomization (±1 week)
1 month after randomization (±1 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMC 2023-07-132
  • KCT0009157 (Other Identifier: Korea National Institute of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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