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

NCT04792190

CompletedPhase 4

Sponsor: University of Rochester

Conditions: Atrial Fibrillation

Interventions: dapagliflozin, Placebo

Countries: United States

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 6-12 months of follow-up. This prospective, randomized, multicenter, placebo-controlled trial aims to enroll 25 subjects with AF (paroxysmal or persistent) who are scheduled to undergo catheter ablation of patients.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria

* Eligible for treatment with dapagliflozin per current FDA-approved indications, including: 1) heart failure (NYHA class II-IV) with reduced left ventricular ejection fraction (\<50%), or 2) type 2 diabetes mellitus and established cardiovascular (CV) disease or multiple CV risk factors, or 3) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, 4) adults with chronic kidney disease at risk of progression as defined by the National Kidney Foundation as estimated GFR \<60 ml/minute/1.73 m2.
* 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 6 calendar months prior to consent only in patients with type 2 diabetes mellitus
* Age \> 18 years
* Existing functional CIED or planned to undergo CIED implant as SOC 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
* Last measured estimated GFR \< 25 ml/minute/1.73 m2
* 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

Locations (3)

Portland, Maine, United States
Detroit, Michigan, United States
Rochester, New York, United States