NCT05029115

The Effect of SGLT-2 Inhibitor in Patient With Atrial Fibrillation and Diabetes Mellitus

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 716 (estimated)
• Sponsor: Ewha Womans University Mokdong Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to compare the effects on atrial rhythm control between SGLT2 inhibitor and other oral hypoglycemic agents in patients with atrial fibrillation and diabetes mellitus. We are to compare efficacy and safety between these two groups.

Detailed description

This study is a multicenter, prospective open blinded-endpoint design, 1:1 randomized, and controlled study, with total of 716 patients enrolled from 4-5 centers. The primary outcome is recurrence rate of atrial fibrillation within a year, when recurrence of atrial fibrillation is defined as at least one significant atrial fibrillation documented on 24-hour Holter ECG. Secondary outcomes are atrial fibrillation free survival, atrial fibrillation burden at various time points, ablation rate within a year, atrial fibrillation recurrence rate after ablation within a year, volume of left atrium, NT-ProBNP, Symptom score and Quality of Life.

Conditions

• SGLT-2 Inhibitor
• Atrial Fibrillation
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	SGLT2 inhibitor	Dapagliflozin, Empagliflozin

Timeline

• Start date: 2021-10-05
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2021-08-31
• Last updated: 2023-01-23

Locations

1 site across 1 country: South Korea