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

NCT ID: NCT06740786

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2026-05-01

Brief Summary

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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

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Conditions

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Atrial Fibrillation (AF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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control group

This group of patients will receive placebo treatment.

Group Type PLACEBO_COMPARATOR

Dapagliflozin Treatment Group

Intervention Type 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).

treatment group

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

Group Type EXPERIMENTAL

Dapagliflozin Treatment Group

Intervention Type 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).

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hefei Binhu Hospital

OTHER

Sponsor Role collaborator

The First People's Hospital of Hefei

OTHER

Sponsor Role collaborator

Second People's Hospital of Hefei City

OTHER

Sponsor Role collaborator

The Second People's Hospital of Anhui Province

OTHER

Sponsor Role collaborator

Xu Liu

OTHER

Sponsor Role lead

Responsible Party

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Xu Liu

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Shao Hui Wu, Doctor

Role: CONTACT

Phone: +86 15821960839

Email: [email protected]

Other Identifiers

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DAPAF

Identifier Type: -

Identifier Source: org_study_id