Clinical Impact of SGLT2 Inhibitor After DC Cardioversion in Persistent AF With HFpEF
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥19 years
Persistent atrial fibrillation
H2FPEF score ≥6 or HFA-PEFF score ≥5
Restoration of sinus rhythm after electrical cardioversion
Disqualifiers
Previous use of an SGLT2 inhibitor
Intracardiac thrombus on transesophageal echocardiography
Refusal to participate
Trial design
Design model
Parallel
Treatments tested in this trial
SGLT2 inhibitors (Dapagliflozin and Empagliflozin)
DrugPatients receive an SGLT2 inhibitor (empagliflozin or dapagliflozin) after successful DC cardioversion, in addition to guideline-directed anticoagulation and antiarrhythmic drugs for 1 month.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: SGLT2 inihibitorExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
1 month after randomization (±1 week)Secondary outcomes
1
Recurrence of atrial fibrillation
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)2
Recurrence of atrial flutter
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)3
Recurrence of atrial tachycardia
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)4
Stroke
Time frame
1 month after randomization (±1 week)Sponsors and contacts
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Source ClinicalTrials.gov