Trials / Unknown
UnknownNCT05816733
Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure
Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure: Prospective Randomized Trial (DETAIL-CMIV)
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 348 (estimated)
- Sponsor
- Kun Hua · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Atrial Fibrillation Recurrence
- Cox Maze IV
- Atrial Fibrillation
- Patients With or Without Heart Failure and Diabetes
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dapagliflozin | Patients randomized in this arm will receive dapagliflozin at a target dose of 10mg once daily and routine treatment. |
| DRUG | Placebo | Patients randomized in this arm will receive placebo at a target dose of 10mg once daily and routine treatment. |
Timeline
- Start date
- 2023-09-01
- Primary completion
- 2024-06-07
- Completion
- 2024-08-07
- First posted
- 2023-04-18
- Last updated
- 2023-11-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05816733. Inclusion in this directory is not an endorsement.