RECURrence of Atrial Fibrillation After Cardioversion of Patients Randomized to Dapagliflozin or Usual Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dapagliflozin 10 mg once daily.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
RECURrence of Atrial Fibrillation After Cardioversion of Patients Randomized to Open-label Treatment With Dapagliflozin or Usual Care
Overview
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
- Drug Dapagliflozin 10 mg once daily
Tablet Dapagliflozin 10 mg orally during from randomization for maximum 56 days.
Primary outcome measures
- Atrial fibrillation recurrence [Time frame: 30 days after elective electrical cardioversion]
Secondary outcome measures (7)
- Proportion of patients in SR at 30 days [Time frame: 30 days after elective electrical cardioversion]
- Proportion of patients without any atrial fibrillation recurrence at 30 days [Time frame: 30 days after elective electrical cardioversion]
- Time to spontaneous return to sinus rhythm before electrical cardioversion [Time frame: Up to 26 days]
- Spontaneous return to sinus rhythm before cardioversion. [Time frame: Up to 26 days]
- Success of cardioversion [Time frame: Periprocedural]
- Total number of days with atrial fibrillation [Time frame: From day of electric cardioversion to 30 days after]
- Absence of clinical atrial fibrillation recording [Time frame: From randomization to 30 days after electric cardioversion]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Sweden · 7 centers
- Linköping university hosptial — Linköping
- Örebro University hospital — Örebro
- Södersjukhuset — Stockholm
- Karolinska University Hospital — Stockholm
- Danderyds Hospital — Stockholm
- Norrlands universitetssjukhus — Umeå
- Akademiska sjukhuset — Uppsala
Identifiers
NCT: NCT07187570 · EU CT 2024-513719-28-00 · 2024-513719-28-00