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New treatment option for Atrial Fibrillation
Official title Effect of Enavogliflozin on Recurrence of Atrial Fibrillation After Catheter Ablation
ClinicalTrials.gov ID: NCT06528262
What this study is testing
What is Enavogliflozin?
Enavogliflozin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for atrial fibrillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Objective: The purpose of this study is to determine if there is a difference in the recurrence rate of atrial fibrillation (AF) between a group of patients with AF and heart failure undergoing catheter ablation who are administered the SGLT2 inhibitor, Enavogliflozin, and a control group (placebo group). This study aims to investigate whether SGLT2 inhibitors can prevent the recurrence of AF after the procedure.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 84
You may be able to join if
- Adults aged 19 to under 85
- Patients who consent to participate in the study and can be followed up during the study
- Patients with AF and heart failure who have undergone atrial fibrillation catheter ablation within the last three months or are scheduled to undergo...
You likely can't join if
- Under 19 or over 85 years old
- Patients who have participated in another clinical trial within the last three months
- Life expectancy of less than one year
- Pregnant or breastfeeding women
- Currently being treated with an SGLT-2 inhibitor
- Three or more urinary or genital infections within the last year
See the full eligibility criteria
- Adults aged 19 to under 85
- Patients who consent to participate in the study and can be followed up during the study
- Patients with AF and heart failure who have undergone atrial fibrillation catheter ablation within the last three months or are scheduled to undergo the procedure
- Under 19 or over 85 years old
- Patients who have participated in another clinical trial within the last three months
- Life expectancy of less than one year
- Pregnant or breastfeeding women
- Currently being treated with an SGLT-2 inhibitor
- Three or more urinary or genital infections within the last year
- Uncontrolled hypertension: systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 110mmHg
- Systolic blood pressure \< 90mmHg
- Acute cardiovascular event within the last 12 weeks
- Severe valvular disease or presence of artificial valves
- Renal impairment (eGFR CKD-EPI \< 60 ml/min/1.73m²)
- Clinically confirmed liver dysfunction
- Uncontrolled thyroid dysfunction
- Patients with active cancer (including those undergoing treatment) or history of cancer within the last five years at the time of screening; however, borderline cancers are not excluded if successfully treated and...
- Continuous use of oral prednisolone at 10mg/day or equivalent, or higher doses of steroids, within the last month
- Patients with hypersensitivity or history of hypersensitivity to the active or inactive ingredients of this drug
- Patients with type 1 diabetes or diabetic ketoacidosis
- History of alcohol or substance abuse
- Women of childbearing potential who do not agree to use adequate contraception during the clinical trial period
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 84 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.