Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation
NCT ID: NCT04792190
Last Updated: 2024-12-04
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
25 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-07-27
Study Completion Date
2023-06-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Atrial Fibrillation
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Intervention Management Arm (Dapagliflozin)
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.
Group Type
ACTIVE_COMPARATOR
dapagliflozin
Intervention Type
DRUG
Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily, for 12 months.
Control Arm (Placebo)
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.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Subjects will take 1 blinded capsule of placebo drug dosed once daily
Interventions
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dapagliflozin
Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily, for 12 months.
Intervention Type
DRUG
Placebo
Subjects will take 1 blinded capsule of placebo drug dosed once daily
Intervention Type
DRUG
Eligibility Criteria
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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.
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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AstraZeneca
INDUSTRY
Sponsor Role
collaborator
University of Rochester
OTHER
Sponsor Role
lead
Responsible Party
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Mehmet Aktas
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Mehmet Aktas, MD
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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Maine Medical Center
Portland, Maine, United States
Site Status
Henry Ford Hospital
Detroit, Michigan, United States
Site Status
University of Rochester Medical Center
Rochester, New York, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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00005844
Identifier Type: -
Identifier Source: org_study_id