NCT06111443

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for phase_2

Timeline
7mo left

Started Dec 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Dec 2023Nov 2026

First Submitted

Initial submission to the registry

August 31, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

December 21, 2023

Status Verified

August 1, 2023

Enrollment Period

3 years

First QC Date

August 31, 2023

Last Update Submit

December 19, 2023

Conditions

Atrial Fibrillation RecurrentCatheter Ablation

Outcome Measures

Primary Outcomes (1)

  • Freedom from all atrial tachyarrhythmias (AF/AFL/AT)

    Freedom from all atrial tachyarrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 7-day Holter test at 3, 6, and 12-month follow-up) and 12-lead electrocardiogram (ECG) performed at cardiovascular (CV) outpatient department (OPD) follow-up within one-year post catheter ablation. (unit: %)

    3,6 and 12 months after ablation

Secondary Outcomes (12)

  • Freedom from all atrial tachyarrhythmias (AF/AFL/AT) excluding the 3-month blanking period

    6 and12 months after ablation

  • Freedom from all atrial tachyarrhythmias (AF/AFL/AT) within 3-month blanking period

    3 months after ablation

  • Total mortality or hospitalization due to CV cause

    12 months after ablation

  • Left atrial (LA) size (LA dimension and LA volume index) by echocardiography

    6 and 12 months

  • AF quality of life (QOL) by AF Effect On Quality-Of-Life (AFEQT) questionnaire score

    1,3,6,9 and 12 months

  • +7 more secondary outcomes

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin (FORXIGA) 10 mg QD for 3 months

Drug: Dapagliflozin 10 mg [Farxiga]

Usual care

NO INTERVENTION

guideline-direct usual care

Interventions

Dapagliflozin 10 mg [Farxiga]DRUG

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

Dapagliflozin

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaoshiung Chang Gung Memorial

Kaohsiung City, Taiwan

Location

MeSH Terms

Interventions

dapagliflozin

Study Officials

  • Yung-Lung Chen

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2023

First Posted

November 1, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

December 21, 2023

Record last verified: 2023-08

Locations

TW(1)