RECURrence of Atrial Fibrillation After Cardioversion of Patients Randomized to Dapagliflozin or Usual Care
- Conditions
- Atrial Fibrillation (AF)
- Interventions
- Drug: Dapagliflozin 10 mg once daily
- Registration Number
- NCT07187570
- Lead Sponsor
- Region Stockholm
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1600
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dapagliflozin Dapagliflozin 10 mg once daily Tablet Dapagliflozin 10 mg once daily
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Proportion of patients in SR at 30 days 30 days after elective electrical cardioversion Proportion of patients in SR 30 days after cardioversion.
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)
Success of cardioversion Periprocedural Discharged with sinus rhythm after electric 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).
Trial Locations
- Locations (7)
Linköping university hosptial
🇸🇪Linköping, Sweden
Örebro University hospital
🇸🇪Örebro, Sweden
Södersjukhuset
🇸🇪Stockholm, Sweden
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Danderyds Hospital
🇸🇪Stockholm, Sweden
Norrlands universitetssjukhus
🇸🇪Umeå, Sweden
Akademiska sjukhuset
🇸🇪Uppsala, Sweden
Linköping university hosptial🇸🇪Linköping, SwedenLars O Karlsson, MD PhDPrincipal Investigator