Dapagliflozin to prevent atrial fibrillation coming back after cardioversion
RECURrence of Atrial Fibrillation After Cardioversion of Patients Randomized to Open-label Treatment With Dapagliflozin or Usual Care
This trial tests whether taking dapagliflozin once daily can reduce the chance that atrial fibrillation returns after an electric cardioversion in adults aged 55 and older.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1600 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Locations | 7 sites (Linköping and 6 other locations) |
| Trial ID | NCT07187570 on ClinicalTrials.gov |
What this trial studies
This randomized phase 3 study enrolls adults aged 55 and older with atrial fibrillation who are scheduled for electrical cardioversion and assigns them to dapagliflozin 10 mg once daily or to usual care. Participants take the study drug (or no drug) for up to 56 days, undergo the planned cardioversion, and record their heart rhythm with a hand-held ECG device that transmits data to the investigators. The main outcome is recurrence of atrial fibrillation during the 56-day monitoring period. The trial is conducted at multiple academic hospitals in Sweden and excludes patients with prior heart failure, type 1 diabetes, current SGLT2 inhibitor use, recent or planned pulmonary vein isolation, or severe kidney impairment.
Who should consider this trial
Good fit: Adults aged 55 or older with atrial fibrillation scheduled for electrical cardioversion who are not currently on an SGLT2 inhibitor, do not have heart failure or type 1 diabetes, and have eGFR ≥25 mL/min/1.73 m2 are the intended participants.
Not a fit: Patients with prior or current heart failure, type 1 diabetes, current SGLT2 inhibitor use, very low kidney function (eGFR <25), or those planning pulmonary vein isolation during the study period are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, dapagliflozin could lower short-term recurrence of AF after cardioversion, reducing symptoms and the need for repeat procedures.
How similar studies have performed: Some observational studies and secondary analyses of SGLT2 inhibitors have reported fewer atrial arrhythmias, but randomized evidence specifically preventing AF recurrence after cardioversion is limited, so this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Linköping and 6 other locations
- Linköping university hosptial — Linköping, Sweden (Not_yet_recruiting)
- Örebro University hospital — Örebro, Sweden (Recruiting)
- Södersjukhuset — Stockholm, Sweden (Not_yet_recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
- Danderyds Hospital — Stockholm, Sweden (Not_yet_recruiting)
- Norrlands universitetssjukhus — Umeå, Sweden (Not_yet_recruiting)
- Akademiska sjukhuset — Uppsala, Sweden (Not_yet_recruiting)
Study contacts
- Principal investigator: Karolina Szummer, MD PhD — Karolinska Institutet
- Study coordinator: Karolina Szummer, MD PhD
- Email: karolina.szummer@regionstockholm.se
- Phone: +4681238000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.