Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation

Part of paid clinical trials in Portland, Maine.

Sponsor
University of Rochester
Study ID
NCT04792190
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • dapagliflozin — DRUG
    Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily, for 12 months.
  • Placebo — DRUG
    Subjects will take 1 blinded capsule of placebo drug dosed once daily

Study Details

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.

Key Dates

Start date
Jul 27, 2021
Status verified
Nov 2024
Primary completion
Mar 31, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Placebo Comparator: 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.

Primary Outcome Measure

Mean Percentage of Time Spent in Atrial Fibrillation [ Time Frame: 12 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Maine Medical CenterPortlandMaine04102-
Henry Ford HospitalDetroitMichigan48202-
University of Rochester Medical CenterRochesterNew York14642-

Find similar trials in Portland, ME

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Maine Medical Center· Portland, MEHenry Ford Hospital· Detroit, MIUniversity of Rochester Medical Center· Rochester, NY

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