NCT06111443Active, not recruitingPhase 2/3
Effect of Dapagliflozin on the Recurrence of Atrial Tachyarrhythmia in Patients Undergoing Catheter Ablation of Atrial Fibrillation
Effect of Dapagliflozin on the Recurrence of Atrial Tachyarrhythmia in Patients Undergoing Catheter Ablation of Atrial Fibrillation - A Randomized Open-Label Phase III Trial
Source: ClinicalTrials.gov · Last updated 21 Dec 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 196 (estimated)
- First submitted
- 31 Aug 2023
- Start date
- 1 Dec 2023
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Chang Gung Memorial Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT06111443
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 196
- From 1 Dec 2023 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Type 1 diabetes mellitus
- Active malignancy
- 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)
Lab values
- Receiving therapy with a sodium-glucose cotransporter 2 (SGLT2) inhibitor prior to randomization, or intolerance to an SGLT2 inhibitor.
Other
- Women of child-bearing potential who have a positive pregnancy test at randomization or who are breast-feeding
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kaoshiung Chang Gung Memorial Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.