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Atrial Fibrillation RecurrentPhase 2/3NCT06111443

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

A Phase 2/3 study testing Dapagliflozin 10 mg [Farxiga] in people with Atrial Fibrillation Recurrent and Catheter Ablation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Dapagliflozin 10 mg [Farxiga]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
1 siteTaiwan
Study dates
1 Dec 2023to 30 Nov 2026
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaoshiung Chang Gung Memorial

    Kaohsiung City

Other trials in Taiwan

About this study

Official title: Effect of Dapagliflozin on the Recurrence of Atrial Tachyarrhythmia in Patients Undergoing Catheter Ablation of Atrial Fibrillation - A Randomized Open-Label Phase III Trial

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.

Read the detailed description

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.

Being tested
Dapagliflozin 10 mg [Farxiga]

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dapagliflozin 10 mg [Farxiga]Drug

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

Study groups in NCT06111443
Study groupRoleWhat they receive
DapagliflozinExperimentalDapagliflozin (FORXIGA) 10 mg QD for 3 months
Receives: Drug: Dapagliflozin 10 mg [Farxiga]
Usual careNo interventionguideline-direct usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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: %)

    Measured: 3,6 and 12 months after ablation

Secondary outcomes (12)

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

    Freedom from all atrial tachyarrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 7-day Holter at 6 and 12-month follow-up) and 12-lead ECG performed at CV OPD follow-up since 3 months post catheter ablation within one year post catheter ablation. (a conventional 3-month blanking period from catheter ablation was used in both groups during which arrhythmia recurrences were not counted toward the recurrent endpoint) (unit: %)

    Measured: 6 and12 months after ablation

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

    Freedom from all atrial tachyarrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 7-day Holter at 3-month follow-up) or 12-leads ECG within 3 months following index ablation (within blanking period) (unit: %)

    Measured: 3 months after ablation

  3. Total mortality or hospitalization due to CV cause

    Total mortality or hospitalization due to cardiovascular cause within one year after ablation (unit: %)

    Measured: 12 months after ablation

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

    Left atrial (LA) size (LA dimension in mm and LA volume index in mL/m2) by echocardiography at 6 and 12 months

    Measured: 6 and 12 months

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

    Change in AF QOL at 1 month, 3 months, 6 months, 9 months and 12 months after receiving catheter ablation relative to baseline: defined as a change in AF QOL assessed in the validated AFEQT questionnaire score. (no unit)

    Measured: 1,3,6,9 and 12 months

  6. N-terminal pro-brain natriuretic peptide (NT-proBNP) level

    Blood test for plasma NT-proBNP level in pg/ml

    Measured: 3 and 12 months

  7. Glycated Hemoglobin (HBA1c)

    HBA1c in %, serum creatinine in mg/dl

    Measured: 3 and 12 months

  8. Creatinine (Cr) and estimated Glomerular filtration rate (eGFR)

    serum Cr in mg/dl, estimated Glomerular filtration rate (eGFR) by MDRD formula in ml/min per 1.73 m2 (calculated according to serum Cr, age, and sex)

    Measured: 3 and 12 months

  9. Urine albumin/Cr ratio level

    Urine albumin/Cr ratio in mg/g

    Measured: 3 and 12 months

  10. Repeated catheter ablation or cardioversion for atrial tachyarrhythmia

    Repeated catheter ablation or cardioversion for atrial tachyarrhythmia within one year (unit: %)

    Measured: 12 months

  11. Adverse events: hypoglycemia, hypotension, hypokalemia, renal function deterioration

    Adverse events: hypoglycemia, hypotension, hypokalemia, renal function deterioration (defined as decline in the estimated GFR of at least 50%) (unit:%)

    Measured: 12 months

  12. AF burden

    AF burden in % documented by 7-day Holter at 3, 6 and 12 months

    Measured: 3,6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2023
  2. Study start1 Dec 2023
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
196 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06111443
Sponsor's protocol ID
CPRPG8N0011
Status last verified
Aug 2023
First submitted
31 Aug 2023
Last updated
21 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Dapagliflozin 10 mg [Farxiga] in people with Atrial Fibrillation Recurrent and Catheter Ablation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from all atrial tachyarrhythmias (AF/AFL/AT) (time frame: 3,6 and 12 months after ablation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06111443.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.

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