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Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure

NCT05816733 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2023-11-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Kun Hua

    lead OTHER

Principal Investigators

  • Kun Hua · Beijing Anzhen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-06-07
Completion
2024-08-07

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05816733 on ClinicalTrials.gov