None listed
Conditions
Brief summary
Atrial fibrillation (AF) is common, and makes people often feel symptoms, or have complications such as stroke. Doctors have many options for AF treatment, but these all have drawbacks. Tablets for AF often have side effects, and AF ablation is the most effective option we have, but unfortunately comes with risks of major complications. Researchers have therefore been looking for other options. SGLT2 inhibitors are medications, which are used to treat diabetes. Unexpectedly, this drug class was shown in a trial of 17,160 patients with heart failure, to reduce the rates of AF. This class of medication was developed as a diabetes medication, working on the kidney to increase the amount of sugar that the body gets rid of into the urine, and therefore lowering the sugar levels in the body. These medications have also been shown to reduce cardiovascular death, reduce heart failure and reduce renal failure. Researchers and doctors don’t exactly understand all the different ways that these medications lead to benefits, in particular how they reduce AF. There may be many different pathways in the body that impact the way that cells work. This project is to try and examine if dapagliflozin (an SGLT2 inhibitor) changes the electrical properties of the heart, to try and explain the reduction in AF that has been shown in trials.
Interventions
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
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.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients referred for clinically indicated AF ablation
Exclusion criteria
People under the age of 18. Patients who are unable or unwilling to provide consent. Considerations related to AF ablation procedure (presence of left atrial thrombus, previous AF ablation, contraindication to anticoagulation). Exclusions related to SGLT2 commencement; patients already taking SGLT2 inhibitors, history of impaired kidney function (eGFR <45mL/min/1.73m2), Child-Pugh Class C liver disease, pregnancy/ breastfeeding, symptomatic hypotension/ systolic blood pressure <100mmHg, type 1 diabetes mellitus, or previous SGLT2 intolerance or allergy, in line with current published contraindications to therapy.
Outcome results
None listed