Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation (DAPA-AF)

University of Rochester

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Drug: dapagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04792190

00005844

Details and patient eligibility

About

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.

Full description

This is a multicenter trial to evaluate the impact of treatment with dapagliflozin versus placebo following catheter ablation of 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. All enrolled subjects will be required to have a cardiac implantable electronic device (CIED) capable of assessing the burden of AF. Following catheter ablation for AF and functional CIED subjects will be randomized to treatment with dapagliflozin 10 mg once daily versus placebo. The primary endpoint for the trial will be AF burden assessed at 6-12 months following catheter ablation of AF. The Investigational Drug Services at the University of Rochester will be in charge of dispensing all study related drugs to subject.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups, including a placebo group

Intervention Management Arm (Dapagliflozin)

Active Comparator group

Description:

A block randomization method will be use to randomize subjects to treatment with dapagliflozin 10 mg once daily. Subjects will take 1 blinded tablet of study drug (dapagliflozin) dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.

Treatment:

Drug: dapagliflozin

Control Arm (Placebo)

Placebo Comparator group

Description:

Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.

Treatment:

Drug: Placebo