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

Sponsor
Samsung Medical Center
Study ID
NCT07776054
Phase
PHASE4
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 20, 2026
Start date
Feb 1, 2024
Status verified
Aug 2026
Primary completion
Aug 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • No Intervention: Control
    Patients receive guideline-directed anticoagulation and antiarrhythmic drugs after DC cardioversion, without an SGLT2 inhibitor.

Primary Outcome Measure

Recurrence of atrial tachyarrhythmia [ Time Frame: 1 month after randomization (±1 week) ]

Central Contacts

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