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

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 Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Drug: Dapagliflozin Treatment Group

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shao Hui Wu, Doctor; Phone Number: +86 15821960839; Email: wushaohui18@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group; This group of patients will receive placebo treatment.	Drug: Dapagliflozin Treatment Group; This group of patients will receive dapagliflozin treatment after undergoing atrial fibrillation catheter ablation. Treatment regimen: Dapagliflozin will be administered orally once daily at the recommended dose (e.g., 10 mg/day).
Experimental: treatment group; Dapagliflozin will be administered orally once daily at the recommended dose (e.g., 10 mg/day).	Drug: Dapagliflozin Treatment Group; This group of patients will receive dapagliflozin treatment after undergoing atrial fibrillation catheter ablation. Treatment regimen: Dapagliflozin will be administered orally once daily at the recommended dose (e.g., 10 mg/day).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The recurrence of atrial arrhythmias	The recurrence of atrial arrhythmias within 12 months as assessed by ECG and holter, beyond the 3-month blanking period.	Within 12 months, beyond the 3-month blanking period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The recurrence of atrial fibrillation	The recurrence of atrial fibrillation within 12 months as assessed by ECG and holter, beyond the 3-month blanking period.	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	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.	12 months post-ablation.
Atrial Fibrillation Burden	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.	after 1 year post-ablation
Number of participants with adverse events	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.	12 months post-ablation.

Collaborators and Investigators

• Sponsor: Xu Liu
• Collaborators: The First People's Hospital of Hefei; Hefei Binhu Hospital; The Second People's Hospital of Anhui Province; Second People's Hospital of Hefei City

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease Attributes; Arrhythmias, Cardiac; Recurrence; Atrial Fibrillation; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Dapagliflozin
• Other Study ID Numbers: DAPAF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No