Sodium-Glucose Co-Transporter 2 inhibition prior to cardiac surgery and postoperative atrial fibrillation: a pilot randomised controlled trial
The effect of Sodium-Glucose Co-Transporter 2 inhibition prior to cardiac surgery on intraoperative electrophysiologic parameters and post-operative atrial fibrillation: a pilot randomised controlled trial
Flinders University
16 participants
Jun 11, 2021
Interventional
Conditions
Summary
Post-operative atrial fibrillation is a heart rhythm disorder that is a major clinical problem, affecting 15-30% of patients undergoing cardiac surgery. It is associated with high rates of stroke, and increased mortality. Post-operative atrial fibrillation is thought to be caused by abnormalities in the physiological function of the atrium around the time of surgery. The current application is for a pilot open-label randomised controlled trial assessing the impact of sodium-glucose co-transporter 2 inhibitor pre-treatment on cardiac electrophysiology studies performed during cardiac surgery in 16 patients. The rationale for the study is that this medication has been shown in a very large randomised controlled trial (Wiviott SD et al. NEJM 2019 "DECLARE-TIMI 58" trial) to decrease incident atrial fibrillation by 19%. We therefore reason that these medications may potentially mediate this effect. The aim of the current study is to determine if pre-treatment will improve the electrical function of the atrium, or change the rates of postoperative atrial fibrillation.
Eligibility
Inclusion Criteria1
- Participants undergoing planned elective cardiac surgery (> 1 month prior to surgical date at time of enrolment)
Exclusion Criteria4
- Patients who are unable or unwilling to provide consent.
- Patients who do not have access to a smartphone.
- Patients who do not consent to study coordinator discussing their involvement with their GP.
- Contraindications to SGLT2 commencement; patients already taking SGLT2 inhibitors, history of impaired kidney function (eGFR <45mL/min/1.73m2), Child –Pugh C cirrhosis, 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.
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Interventions
Randomisation to dapagliflozin tablet, orally, 10mg daily for 1 month before and after cardiac surgery versus standard of care. The total duration of dapagliflozin will be 2 months. In further detail, total duration of treatment is 56 days. Treatment will be initiated 31 days prior to surgery and participants will receive 28 days of medication, then the medication will be withheld for 3 days prior to surgery, and then withheld on the day of the surgery. Treatment will be re-initiated post-operatively once the participant is eating and drinking normally, which is likely to be on the first postoperative day. Post operatively, 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 postoperatively, to transmit their cardiac traces twice a day postoperatively. Participants taking dapagliflozin will be phoned every 2 weeks during the trial period to assess for side effects and answer questions, and 3 days before surgery to ensure cessation of medication. 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 surgery, an in person visit 4 weeks after surgery. Medication collection/ adherence will be documented by pharmacy department.
Locations(1)
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ACTRN12621000684820