Efficacy and Safety of Dapagliflozin in Preventing Atrial Fibrillation Recurrence After Catheter Ablation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 250
- Primary Endpoint
- The recurrence of atrial arrhythmias
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
control group
This group of patients will receive placebo treatment.
Intervention: Dapagliflozin Treatment Group (Drug)
treatment group
Dapagliflozin will be administered orally once daily at the recommended dose (e.g., 10 mg/day).
Intervention: Dapagliflozin Treatment Group (Drug)
Outcomes
Primary Outcomes
The recurrence of atrial arrhythmias
Time Frame: 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.
Secondary Outcomes
- 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.)
Investigators
Xu Liu
Professor
Shanghai Chest Hospital