Samsung Medical Center
Seoul, 06351, South Korea
Location status: Recruiting
NCT Number: NCT07776054
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.
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Phase 4
Seoul, 06351, South Korea
Location status: Recruiting
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%).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients receive an SGLT2 inhibitor (empagliflozin or dapagliflozin) after successful DC cardioversion, in addition to guideline-directed anticoagulation and antiarrhythmic drugs for 1 month.
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.
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.
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.
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.
Time frame: 1 month after randomization (±1 week)
Contact information is provided by the study sponsor or research team.
Samsung Medical Center
Other
Clinical Impact of SGLT2 Inhibitor After DC Cardioversion in Persistent Atrial Fibrillation Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Controlled Trial
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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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