Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure

Phase 4

Recruiting

• Conditions: Cox Maze IV; Atrial Fibrillation; Patients With or Without Heart Failure and Diabetes; Atrial Fibrillation Recurrence
• Interventions: Drug: Placebo; Drug: Dapagliflozin

• Registration Number: NCT05816733
• Lead Sponsor: Kun Hua

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-02
• Study First Submitted QC: 2023-04-16
• Study First Posted: 2023-04-18
• Study Start: 2023-09-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-29
• Primary Completion: 2024-06-07
• Study Completion: 2024-08-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 348

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Patients who will be randomized to receive placebo following the Cox-Maze IV Procedure.
Dapagliflozin group	Dapagliflozin	Patients who will be randomized to receive dapagliflozin following the Cox-Maze IV Procedure.

Primary Outcome Measures

Name	Time	Method
Rate of atrial fibrillation recurrence	half of one year post operative

Secondary Outcome Measures

Name	Time	Method
Rate of atrial fibrillation recurrence	one year post operative
Cardiovascular complex adverse events	one year post operative	cardiogenic death, new onset heart failure, malignant arrhythmias, stroke

Trial Locations

Locations (1)

Cardiac Surgery Center No. 7; 🇨🇳 Beijing, Beijing, China