MedDataX Logo

Effect of Dapagliflozin on the Recurrence of Atrial Tachyarrhythmia in Patients Undergoing Catheter Ablation of Atrial Fibrillation

NCT ID: NCT06111443

Last Updated: 2023-12-21

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to test the effect of Dapagliflozin on the Recurrence of Atrial Tachyarrhythmia in Patients Undergoing Catheter Ablation of Atrial Fibrillation. The main questions it aims to answer are:

• If Dapagliflozin will reduce the recurrence of all atrial tachyarrhythmias \[atrial fibrillation (AF), atrial flutter (AFL) and atrial tachycardia (AT)\] greater than 30 seconds during one-year follow-up after catheter ablation.

Participants will receive Dapagliflozin (FORXIGA) 10 milligram (mg) once a day (QD) for 3 months after catheter ablation of atrial fibrillation. Researchers will compare patients who receive usual care to see if Dapagliflozin will reduce the recurrence of all atrial tachyarrhythmias (AF/AFL/AT) during one-year follow-up after catheter ablation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This trial is the third phase of random allocation and non-blind trial. It is divided into study group and control group. The study group is Dapagliflozin therapy, and the treatment period is three months post catheter ablation. The control group is usual care (without Dapagliflozin). The follow-up observation period will be one year after catheter ablation. This trial was performed at Kaohsiung Chang Gung Memorial Hospital and Chang Gung Memorial Hospital, Linkou, and Chiayi branches, and it is a multi-center trial. The study flow chart is as follows.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation Recurrent Catheter Ablation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dapagliflozin

Dapagliflozin (FORXIGA) 10 mg QD for 3 months

Group Type EXPERIMENTAL

Dapagliflozin 10 mg [Farxiga]

Intervention Type DRUG

Dapagliflozin 10 mg \[Farxiga\] for 3 months after catheter ablation of atrial fibrillation

Usual care

guideline-direct usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dapagliflozin 10 mg [Farxiga]

Dapagliflozin 10 mg \[Farxiga\] for 3 months after catheter ablation of atrial fibrillation

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Ability to give written informed consent
* Men and women age \>= 20 years.
* Paroxysmal, persistent or long-standing persistent atrial fibrillation
* eGFR \>= 25 ml/min/1.73 m2

Exclusion Criteria

* Receiving therapy with a sodium-glucose cotransporter 2 (SGLT2) inhibitor prior to randomization, or intolerance to an SGLT2 inhibitor.
* Type 1 diabetes mellitus
* Acute coronary syndrome, coronary revascularization (percutaneous coronary intervention or Coronary artery bypass grafting), ablation of atrial flutter/fibrillation, ischemic stroke, and transient ischemic attack within 12 weeks prior to randomization
* Active malignancy
* Women of child-bearing potential who have a positive pregnancy test at randomization or who are breast-feeding
* A life expectancy of fewer than 2 years due to any non-cardiovascular condition, based on the investigator's clinical judgment
* Expected surgery for structural heart disease, and secondary atrial fibrillation (due to cardiac surgery, infection, or hyperthyroidism)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yung-Lung Chen

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kaoshiung Chang Gung Memorial

Kaohsiung City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CPRPG8N0011

Identifier Type: -

Identifier Source: org_study_id