Clinical trial NCT04792190: Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation
Official title: Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation (DAPA-AF) Prospective, Randomized, Multicenter, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2021-03-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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: 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.

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

Primary outcomes:
measure: Mean Percentage of Time Spent in Atrial Fibrillation
timeFrame: 12 months
Secondary outcomes:
measure: Rate of Health Care Utilization
timeFrame: 6-12 months
measure: Percentage of Participants Hospitalized for Heart Failure Post Catheter Ablation of AF
timeFrame: 6-12 months
measure: Mean Quality of Life Score Using the QualiTy-of-life (AFEQT) Questionnaire
timeFrame: Final visit, approximately 12 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: Principal Investigator
name: Mehmet Aktas, MD
role: PRINCIPAL_INVESTIGATOR
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