Sodium-glucose co-transporter 2 inhibition prior to atrial fibrillation ablation: A pilot randomised controlled trial

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: Randomisation to dapagliflozin tablet, orally, 10mg daily for 1 month before and after atrial fibrillation ablation, versus standard of care. Total duration of treatment is 56 days. Treatment will be initiated 31 days prior to AF ablation and participants will receive 28 days of medication, then the medication will be withheld for 3 days prior to AF ablation, and withheld on the day of the AF ablation. Treatment will be re‐initiated on the first post‐procedural day, if the participant is eating and drinking normally. Post procedurally, the medication will be given for 28 days. The pharmacy department will record the date of dispensing, and the number of tablets given. The pharmacy department also ask the participants to return unused medications, the number of unused tablets will be recorded on the study log. Participants will be provided with an AliveCor cardiac monitor, to transmit their cardiac traces twice a day post‐procedurally. Participants taking dapagliflozin will be phoned every 2 weeks during the trial period, and 3 days before ablation to ensure cessation of medication while fasting. Participants will be given a trial information booklet. Cardiology consultants and fellows will be responsible for administering the trial, some elements over the phone and some in person visits; initial visit for consent/ collecting medication in person, phonecall after 2 weeks, another phonecall after 11 days, another phonecall 2 weeks post ablation, an in person visit 4 weeks after ablation for trial completion. CONDITION: Atrial fibrillation; ; Atrial fibrillation Cardiovascular ‐ Other cardiovascular diseases PRIMARY OUTCOME: Atrial fibrillation burden; proportion of traces showing atrial fibrillation; ; Participants will be asked to return two traces each day of their heart rhythm, and additional traces if they experience symptoms concerning for atrial fibrillation, via their AliveCor device and compatible smartphone.[Assessed once daily for 1 month post ablation.] Change in electrogram fractionation between the treatment and control groups.; ; Electrogram fractionation is assessed from the raw electrograms collected during the electrophysiology study.[Data collected at the time of ablation (during the procedure).; The ablation will occur following 4 weeks of drug treatment.] Change in the rate constants between the treatment and control groups.; ; Rate constants are calculated from data collected at the time of electrophysiology study. Raw electrograms collected will be processed using custom Matlab software, to determine the electrophysiologic rate constant.[Data collected at the time of ablation (during the procedure).; The ablation will occur following 4 weeks of drug treatment.] SECONDARY OUTCOME: Change in bipolar voltages between the treatment and control groups. ; ; Bipolar voltages are collected from the raw electrograms collected during the electrophysiology study.[Data collected at the time of ablation (during the procedure). ; The ablation will occur following 4 weeks of drug treatment.] Time to first recurrence of atrial fibrillation ; ; Cardiac monitoring is performed in hospital for 24 hours post ablation. Subsequently, participants will be asked to return two traces each day of their heart rhythm, and additional traces if they experience symptoms concerning for atrial fibrillation via their AliveCor device and compatible smartphone. The first recurrence of atrial fibrillation will be the first documented atrial fibrillation following ablation. The time to recurrence is the time in days to first recurrence of atrial fibrillation.[Assessed once daily for 1 month post ablation. ; ] INCLUSION CRITERIA: Patients referred for clinically indicated AF ablation
Epistemonikos ID: ee5ae80ad59005e842537d3616928673d9ca3c08
First added on: Aug 25, 2024