Efficacy and Safety of Dapagliflozin in Preventing Atrial Fibrillation Recurrence After Catheter Ablation

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation (AF)
• Interventions: Drug: Dapagliflozin Treatment Group

• Registration Number: NCT06740786
• Lead Sponsor: Xu Liu

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study Start: 2024-12-10
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Dapagliflozin Treatment Group	This group of patients will receive placebo treatment.
treatment group	Dapagliflozin Treatment Group	Dapagliflozin will be administered orally once daily at the recommended dose (e.g., 10 mg/day).

Primary Outcome Measures

Name	Time	Method
The recurrence of atrial arrhythmias	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 Outcome Measures

Name	Time	Method
The recurrence of atrial fibrillation	Within 12 months, beyond the 3-month blanking period.	The recurrence of atrial fibrillation within 12 months as assessed by ECG and holter, 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.	Quality of life was assessed using the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire, measuring changes from baseline to 12 months post-ablation.
Atrial Fibrillation Burden	after 1 year post-ablation	Atrial fibrillation burden is defined as the percentage of time spent in atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) detected by a 7-day single-lead ECG patch monitoring after 1 year post-ablation.
Number of participants with adverse events	12 months post-ablation.	The safety of dapagliflozin assessed by researchers, including hypoglycemia, Urinary Tract Infections, dehydration and Hypotension,Acute Kidney Injury, diabetic ketoacidosi, cardiovascular events, severe allergic reactions, severe electrolyte Imbalance,etc.