Efficacy and Safety of Dapagliflozin in Preventing Atrial Fibrillation Recurrence After Catheter Ablation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 主要终点
- The recurrence of atrial arrhythmias
研究概览
简要总结
Atrial fibrillation (AF) is a common arrhythmia, particularly prevalent in the elderly population. Catheter ablation is a common treatment for AF, but post-ablation recurrence of arrhythmias remains a significant clinical challenge. Dapagliflozin, an SGLT2 inhibitor primarily used for the treatment of type 2 diabetes, has shown potential in the field of cardiology, particularly for treating heart failure patients. Some studies suggest that dapagliflozin may reduce cardiac workload, improve heart function, and could even help in the management of atrial fibrillation. Therefore, this study aims to explore whether dapagliflozin can reduce the recurrence of arrhythmias following atrial fibrillation catheter ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Patients aged 18 years and older. Presence of type 2 diabetes or heart failure. Diagnosis of Atrial Fibrillation: Confirmed atrial fibrillation through ECG or Holter monitoring.
- •First-time Catheter Ablation: Patients undergoing their first atrial fibrillation catheter ablation.
- •Voluntary Participation: Patients willing to participate and sign informed consent.
排除标准
- •Presence of urinary tract infection Pregnancy or Breastfeeding: Women who are pregnant, breastfeeding, or planning to become pregnant.
- •Allergy to Dapagliflozin or Similar Drugs: History of allergic reactions to dapagliflozin or other SGLT2 inhibitors.
- •Other Contraindications to Dapagliflozin: Any other contraindications for dapagliflozin use.
- •Kidney Function: eGFR < 45 ml/min/1.73m², with severe kidney disease.
研究组 & 干预措施
control group
This group of patients will receive placebo treatment.
干预措施: Dapagliflozin Treatment Group (Drug)
treatment group
Dapagliflozin will be administered orally once daily at the recommended dose (e.g., 10 mg/day).
干预措施: Dapagliflozin Treatment Group (Drug)
结局指标
主要结局
The recurrence of atrial arrhythmias
时间窗: Within 12 months, beyond the 3-month blanking period.
The recurrence of atrial arrhythmias within 12 months as assessed by ECG and holter, beyond the 3-month blanking period.
次要结局
- The recurrence of atrial fibrillation(Within 12 months, beyond the 3-month blanking period.)
- changes in quality of life at 12 months as assessed by Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire(12 months post-ablation.)
- Atrial Fibrillation Burden(after 1 year post-ablation)
- Number of participants with adverse events(12 months post-ablation.)
研究者
Xu Liu
Professor
Shanghai Chest Hospital