Dapagliflozin 10 mg once daily
DrugTablet Dapagliflozin 10 mg orally during from randomization for maximum 56 days.
Recruiting
NCT Number: NCT07187570
RECURrence of Atrial Fibrillation After Cardioversion of Patients Randomized to Dapagliflozin or Usual Care
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
55 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Linköping university hosptial, Linköping, Sweden
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Atrial fibrillation recurrence
Time frame: 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 outcomes
-
Proportion of patients in SR at 30 days
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Periprocedural
Discharged with sinus rhythm after electric cardioversion
-
Total number of days with atrial fibrillation
Time frame: 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
Time frame: 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).
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Region Stockholm
Other Gov
Collaborators
- Karolinska Institutet
Registry information
Official study title
RECURrence of Atrial Fibrillation After Cardioversion of Patients Randomized to Open-label Treatment With Dapagliflozin or Usual Care
Acronym: RECUR-AF
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Sep 23, 2025
- Registry last updated
- Sep 23, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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