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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513719-28-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | Standard of care | |
| Dapagliflozin | Experimental | Tablet Dapagliflozin 10 mg once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10 mg once daily | Drug | Tablet Dapagliflozin 10 mg orally during from randomization for maximum 56 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation recurrence | Time to first AF recurrence detected with an ECG- monitoring device within 30 days after planned elective electrical cardioversion. | 30 days after elective electrical cardioversion |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients in SR at 30 days | Proportion of patients in SR 30 days after cardioversion. | 30 days after elective electrical cardioversion |
| Proportion of patients without any atrial fibrillation recurrence at 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karolina Szummer, MD PhD | Contact | +4681238000 | karolina.szummer@regionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Karolina Szummer, MD PhD | Karolinska Institutet | Principal Investigator |
| Ziad Hijazi, MD PhD | Dept. of Medical Sciences, Uppsala University, Uppsala, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linköping university hosptial | Not yet recruiting | Linköping | 58225 | Sweden |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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Prospective randomized open blinded end-point (PROBE) study
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Proportion of patients without any atrial fibrillation recurrence at 30 days
| 30 days after elective electrical cardioversion |
| Time to spontaneous return to sinus rhythm before electrical cardioversion | Time to spontaneous return to sinus rhythm measured from randomization to electrical cardioversion (max 26 days) | Up to 26 days |
| Spontaneous return to sinus rhythm before cardioversion. | Number of patients with return to sinus rhythm at time of electrical cardioversion (maximum 26 days from randomization) | Up to 26 days |
| Success of cardioversion | Discharged with sinus rhythm after electric cardioversion | Periprocedural |
| Total number of days with atrial fibrillation | Total number of days with AF recordings during the 30 days following cardioversion. | From day of electric cardioversion to 30 days after |
| Absence of clinical atrial fibrillation recording | Absence of clinical atrial fibrillation recurrence (12-lead ECG-verified) during follow-up after cardioversion or after spontaneous return to SR (before cardioversion). | From randomization to 30 days after electric cardioversion |
| Örebro University hospital | Recruiting | Örebro | 70382 | Sweden |
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| Södersjukhuset | Not yet recruiting | Stockholm | 11861 | Sweden |
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| Karolinska University Hospital | Recruiting | Stockholm | 14186 | Sweden |
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| Danderyds Hospital | Not yet recruiting | Stockholm | 18527 | Sweden |
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| Norrlands universitetssjukhus | Not yet recruiting | Umeå | 90185 | Sweden |
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| Akademiska sjukhuset | Not yet recruiting | Uppsala | 75389 | Sweden |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |