Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure

Sponsor
Kun Hua
Study ID
NCT05816733
Phase
PHASE4
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Patients randomized in this arm will receive dapagliflozin at a target dose of 10mg once daily and routine treatment.
  • Placebo — DRUG
    Patients randomized in this arm will receive placebo at a target dose of 10mg once daily and routine treatment.

Study Details

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.

Key Dates

Start date
Sep 1, 2023
Status verified
Nov 2023
Primary completion
Jun 7, 2024
Completion
Aug 7, 2024

Study Design

Enrollment
348 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Rate of atrial fibrillation recurrence [ Time Frame: half of one year post operative ]

Central Contacts

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