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NCT Number: NCT07776054

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SGLT2 inhibitors (Dapagliflozin and Empagliflozin)

Drug

Patients receive an SGLT2 inhibitor (empagliflozin or dapagliflozin) after successful DC cardioversion, in addition to guideline-directed anticoagulation and antiarrhythmic drugs for 1 month.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Stroke

    Time frame: 1 month after randomization (±1 week)

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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