Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure

Study Overview
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Brief Summary
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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.

Official Title
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Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure: Prospective Randomized Trial (DETAIL-CMIV)

Conditions
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Patients With or Without Heart Failure and Diabetes, Atrial Fibrillation Recurrence, Cox Maze IV, Atrial Fibrillation

Intervention / Treatment
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* Drug: Dapagliflozin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Patients with persistent or long-term persistent atrial fibrillation who need isolated surgical Cox-Maze IV procedure Patients who need cardiac surgery combined with Cox-Maze IV procedure Patients who have the ability and willingness to abide by all the subsequent reviews and requirements Sign the informed consent Exclusion Criteria: Dapagliflozin allergy Hyperthyroidism Patients with acute myocardial infarction, cerebral apoplexy, and other vascular diseases during the past 6 months Patients who received heart surgery within the last 3 months eGFR<45ml/min History of oral SGLT2i Estimated survival period < 12 months Pregnant and lactating women Left atrial diameter > 65 mm Refusing to sign the informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapagliflozin group<br>Patients who will be randomized to receive dapagliflozin following the Cox-Maze IV Procedure. | Drug: Dapagliflozin<br>* Patients randomized in this arm will receive dapagliflozin at a target dose of 10mg once daily and routine treatment.<br>|
| Placebo Comparator: Placebo group<br>Patients who will be randomized to receive placebo following the Cox-Maze IV Procedure. | Drug: Placebo<br>* Patients randomized in this arm will receive placebo at a target dose of 10mg once daily and routine treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of atrial fibrillation recurrence |  | half of one year post operative | 

Secondary Outcome Measures

| Outcome Measure | 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 |