Atrial Fibrillation, DC Cardioversion, SGLT2 Inhibitor
Conditions
Brief summary
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.
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%).
Interventions
Patients receive an SGLT2 inhibitor (empagliflozin or dapagliflozin) after successful DC cardioversion, in addition to guideline-directed anticoagulation and antiarrhythmic drugs for 1 month.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of atrial tachyarrhythmia | 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
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of atrial fibrillation | 1 month after randomization (±1 week) | atrial fibrillation documented on 12-lead ECG or as an episode lasting ≥30 seconds on continuous ECG monitoring. |
| Recurrence of atrial flutter | 1 month after randomization (±1 week) | atrial flutter documented on 12-lead ECG or as an episode lasting ≥30 seconds on continuous ECG monitoring. |
| Recurrence of atrial tachycardia | 1 month after randomization (±1 week) | atrial tachycardia documented on 12-lead ECG or as an episode lasting ≥30 seconds on continuous ECG monitoring. |
| Stroke | 1 month after randomization (±1 week) | — |
Countries
South Korea
Contacts
CONTACTJuwon Kim
Outcome results
None listed