About this trial
The goal of this clinical trial is to learn if drug dapagliflozin, a sodium-glucose transport-2 inhibitor, works to treat atrial fibrillation in adults. The main question it aims to answer is:
• Does the drug dapagliflozin reduce the recurrence rate of atrial fibrillation?
Researchers will compare drug dapagliflozin to standard therapy to see if drug dapagliflozin reduce the recurrence of atrial fibrillation.
Persons with atrial fibrillation who are planned for an electric cardioversion will:
* Take the drug dapagliflozin, or no drug, once a day for a maximum of 56 days * Undergo a planned electric cardioversion of the atrial fibrillation * Record the rhythm with a hand-held device that transmits the signal to researchers during the study period, but no longer than for 56 days
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with AF on ECG who are planned for electrical cardioversion within 7-26 days from inclusion-date.
Age ≥ 55 years.
Provided written informed consent.
Disqualifiers
Current treatment with an SGLT2 inhibitor.
Prior/current diagnosis of heart failure.
Type 1 diabetes mellitus.
Estimated glomerular filtration rate (eGFR) < 25 mL/min/1.73m2.
Trial design
Parallel
Treatments tested in this trial
Dapagliflozin 10 mg once daily
DrugTablet Dapagliflozin 10 mg orally during from randomization for maximum 56 days.
Treatment groups
Trial outcomes
Primary outcomes
Atrial fibrillation recurrence
Time to first AF recurrence detected with an ECG- monitoring device within 30 days after planned elective electrical cardioversion.
Secondary outcomes
Proportion of patients in SR at 30 days
Proportion of patients in SR 30 days after cardioversion.
Proportion of patients without any atrial fibrillation recurrence at 30 days
Proportion of patients without any atrial fibrillation recurrence at 30 days
Time to spontaneous return to sinus rhythm before electrical cardioversion
Time to spontaneous return to sinus rhythm measured from randomization to electrical cardioversion (max 26 days)
Spontaneous return to sinus rhythm before cardioversion.
Number of patients with return to sinus rhythm at time of electrical cardioversion (maximum 26 days from randomization)
Sponsors and contacts
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Region Stockholm
Lead sponsor
Karolinska Institutet
Collaborator