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

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: Recruiting
• Conditions: Atrial Fibrillation; SGLT2 Inhibitor; DC Cardioversion
• Intervention / Treatment: Drug: SGLT2 inhibitors (Dapagliflozin and Empagliflozin)

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: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Juwon Kim; Phone Number: +82-2-3410-2578; Email: abcd186a@naver.com

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 06351
      • Recruiting
      • Samsung Medical Center
      • Contact: Juwon Kim; Phone Number: +82-2-3410-2578; Email: abcd186a@naver.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Recurrence of atrial tachyarrhythmia	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

Outcome Measure	Measure Description	Time Frame
Recurrence of atrial fibrillation	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	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	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		1 month after randomization (±1 week)

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: August 17, 2026
• First Submitted That Met QC Criteria: August 17, 2026
• First Posted (Actual): August 20, 2026

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Pharmacologic Actions; Chemical Actions and Uses; Sodium-Glucose Transporter 2 Inhibitors; empagliflozin; dapagliflozin
• Other Study ID 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