Status:
COMPLETED
Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
AstraZeneca
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 6-12 months of foll...
Detailed 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 prospectiv...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04792190
Start Date
July 27 2021
End Date
June 30 2023
Last Update
December 4 2024
Active Locations (3)
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1
Maine Medical Center
Portland, Maine, United States, 04102
2
Henry Ford Hospital
Detroit, Michigan, United States, 48202
3
University of Rochester Medical Center
Rochester, New York, United States, 14642