Atrial Fibrillation (AF)
Conditions
Keywords
dapagliflozin, sodium-glucose transport-2 inhibitor, electric cardioversion, hand-held ECG device
Brief summary
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
Interventions
Tablet Dapagliflozin 10 mg orally during from randomization for maximum 56 days.
Sponsors
Karolinska Institutet
Region Stockholm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Prospective randomized open blinded end-point (PROBE) study
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Pulmonary vein isolation within preceding 3 months or planned pulmonary vein isolation during the study period (56 days). * Contraindications to SGLT2 inhibitors. * Any condition or circumstance in which the patient should not participate in the study according to the study investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation recurrence | 30 days after elective electrical cardioversion | Time to first AF recurrence detected with an ECG- monitoring device within 30 days after planned elective electrical cardioversion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients without any atrial fibrillation recurrence at 30 days | 30 days after elective electrical cardioversion | Proportion of patients without any atrial fibrillation recurrence at 30 days |
| Time to spontaneous return to sinus rhythm before electrical cardioversion | Up to 26 days | Time to spontaneous return to sinus rhythm measured from randomization to electrical cardioversion (max 26 days) |
| Spontaneous return to sinus rhythm before cardioversion. | Up to 26 days | Number of patients with return to sinus rhythm at time of electrical cardioversion (maximum 26 days from randomization) |
| Proportion of patients in SR at 30 days | 30 days after elective electrical cardioversion | Proportion of patients in SR 30 days after cardioversion. |
| Total number of days with atrial fibrillation | From day of electric cardioversion to 30 days after | Total number of days with AF recordings during the 30 days following cardioversion. |
| Absence of clinical atrial fibrillation recording | From randomization to 30 days after electric cardioversion | Absence of clinical atrial fibrillation recurrence (12-lead ECG-verified) during follow-up after cardioversion or after spontaneous return to SR (before cardioversion). |
| Success of cardioversion | Periprocedural | Discharged with sinus rhythm after electric cardioversion |
Countries
Sweden
Contacts
Primary ContactKarolina Szummer, MD PhD
Outcome results
None listed