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Atrial fibrillation (AF) is the most common arrhythmia, which leads to reduced cardiac output and promotes the occurrence of heart failure, and abnormal hemodynamic changes in the left atrium induce thrombosis, which seriously reduces the quality of life, and even leads to death. For patients who need cardiac surgery combined with the Cox-Maze IV (CMIV) surgical ablation, oral amiodarone postoperatively for three consecutive months was recommended as the preferred treatment option. However, the study found there were still 15%-35% of patients at risk of AF recurrence. Dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, has been widely used for the treatment of type 2 diabetes mellitus and heart failure. Nonetheless, it remains unknown whether dapagliflozin can improve the recurrence of AF and reduces adverse cardiovascular events for patients who need CMIV ablation, and whether it can be routinely used for AF patients without diabetes or heart failure. Therefore, this study aims to explore the effect of postoperative oral dapagliflozin on the recurrence of AF after CMIV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin group | Experimental | Patients who will be randomized to receive dapagliflozin following the Cox-Maze IV Procedure. |
|
| Placebo group | Placebo Comparator | Patients who will be randomized to receive placebo following the Cox-Maze IV Procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Patients randomized in this arm will receive dapagliflozin at a target dose of 10mg once daily and routine treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of atrial fibrillation recurrence | half of one year post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of atrial fibrillation recurrence | one year post operative | |
| Cardiovascular complex adverse events | cardiogenic death, new onset heart failure, malignant arrhythmias, stroke | one year post operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhan Peng | Contact | 010-64456776 | anzhen0607@126.com | |
| Xiubin Yang | Contact | 010-64456776 | xiubinyang@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Kun Hua | Beijing Anzhen Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac Surgery Center No. 7 | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D003920 | Diabetes Mellitus |
| 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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| Placebo | Drug | Patients randomized in this arm will receive placebo at a target dose of 10mg once daily and routine treatment. |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |