Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter trial to evaluate the impact of treatment with dapagliflozin versus placebo following catheter ablation of atrial fibrillation (AF) on the burden of AF during 12 months of follow-up. This prospective, randomized, multicenter, placebo-controlled trial aims to enroll 100 subjects with AF (paroxysmal or persistent) who are scheduled to undergo catheter ablation of patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: AstraZeneca
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin

Criteria

Inclusion Criteria:

• Scheduled to undergo ablation of symptomatic paroxysmal or persistent AF prior to date of randomization per current guideline indications.

• A glycated hemoglobin level < 10.5% during the past 3 calendar months prior to consent

• Estimated glomerular filtrate rate > 30 mL/minute/1.73 m2 during the past 3 calendar months prior to consent

• Age > 18 years

• Eligible for treatment with dapagliflozin per FDA approved indications

• Existing functional CIED or planned to undergo CIED implant as standard of care before or within 24 hours following the AF ablation procedure and prior to randomization date.

Exclusion Criteria:

• Type 1 diabetes mellitus

• History of diabetic keto-acidosis

• Child Pugh Class C liver disease

• Left atrial diameter of 60 mm or greater

• Pregnancy, plan to become pregnant <1 year after consent or breast feeding

• Current therapy with an SGLT2 inhibitor

• Hypersensitivity to dapagliflozin

• On heart transplant list or likely to undergo heart transplant

• Unwilling or unable to cooperate with the protocol

• Participation in other clinical trials (observational registries are allowed with approval).

• Unwilling to sign the consent for participation

• Life expectancy <1 year after consent date for any medical condition