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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Cardiac Surgery Center No. 7
RECRUITING
Beijing
Contact Information
Primary
Zhan Peng
anzhen0607@126.com
010-64456776
Backup
Xiubin Yang
xiubinyang@yahoo.com
010-64456776
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2024-08-07
Participants
Target number of participants: 348
Treatments
Experimental: Dapagliflozin group
Patients who will be randomized to receive dapagliflozin following the Cox-Maze IV Procedure.
Placebo_comparator: Placebo group
Patients who will be randomized to receive placebo following the Cox-Maze IV Procedure.
Sponsors
Leads: Kun Hua

This content was sourced from clinicaltrials.gov