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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily, for 12 months.
Subjects will take 1 blinded capsule of placebo drug dosed once daily
Maine Medical Center
Portland, Maine, United States
Henry Ford Hospital
Detroit, Michigan, United States
University of Rochester Medical Center
Rochester, New York, United States
Mean Percentage of Time Spent in Atrial Fibrillation
For the primary endpoint of AF burden, defined as percentage of time spent in AF (i.e. amount of time spent in AF divided by the total amount of time a patient was monitored), the student's t-test will be used to statistically compare the placebo group vs. the active treatment group. This approach is subject to an examination of the distribution of the percent time in AF. AF data will be collected using a cardiac implantable electronic device (CIED). AF burden assessed at 6-12 months following catheter ablation of AF, defined as percentage of time spent in AF (i.e. amount of time spent in AF divided by the total amount of time a subject was monitored).
Time frame: 12 months
Rate of Health Care Utilization
Rate of health care utilization (recurrent hospitalizations, unplanned office visits, need for emergency room visits)
Time frame: 6-12 months
Percentage of Participants Hospitalized for Heart Failure Post Catheter Ablation of AF
Time frame: 6-12 months
Mean Quality of Life Score Using the QualiTy-of-life (AFEQT) Questionnaire
The AFEQT questionnaire is an AF-specific health-related quality of life questionnaire designed to be used in clinical research. The responses on the AFEQT are scored on a Likert scale, 1 = "Not at all…" to 7 = "Extremely". Scores range from 0 to 100. A score of 0 corresponds to complete disability and a score of 100 corresponds to no disability.
Time frame: Final visit, approximately 12 months
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