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

NCT06740786 | Not Yet Recruiting DMC

• 1 other identifier: DAPAF
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

Study Arms (2)

control group

PLACEBO COMPARATOR

This group of patients will receive placebo treatment.

Drug: Dapagliflozin Treatment Group

treatment group

EXPERIMENTAL

Dapagliflozin will be administered orally once daily at the recommended dose (e.g., 10 mg/day).

Drug: Dapagliflozin Treatment Group

Interventions

Dapagliflozin Treatment Group DRUG

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).

control group; treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Xu Liu: lead
• Hefei Binhu Hospital: collaborator
• The First People's Hospital of Hefei: collaborator
• Second People's Hospital of Hefei City: collaborator
• The Second People's Hospital of Anhui Province: collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shao Hui Wu, Doctor

CONTACT

+86 15821960839; wushaohui18@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 18, 2024
• Study Start: December 10, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share