RECURrence of Atrial Fibrillation After Cardioversion of Patients Randomized to Dapagliflozin or Usual Care (RECUR-AF)

Region Stockholm

Status and phase

Enrolling

Phase 3

Conditions

Atrial Fibrillation (AF)

Treatments

Drug: Dapagliflozin 10 mg once daily

Study type

Interventional

Funder types

Other

Identifiers

NCT07187570

2024-513719-28-00 (EU Trial (CTIS) Number)

EU CT 2024-513719-28-00

Details and patient eligibility

About

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

Enrollment

1,600 estimated patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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.