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NCT Number: NCT06740786

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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

  1. The recurrence of atrial fibrillation

    Time frame: 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.

  2. changes in quality of life at 12 months as assessed by Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire

    Time frame: 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.

  3. Atrial Fibrillation Burden

    Time frame: 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.

  4. Number of participants with adverse events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shao Hui Wu, Doctor

CONTACT

[email protected]

+86 15821960839

Sponsors and collaborators

Lead sponsor

Xu Liu

Other

Collaborators

  • Hefei Binhu Hospital
  • Second People's Hospital of Hefei City
  • The First People's Hospital of Hefei
  • The Second People's Hospital of Anhui Province

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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