Status:
NOT_YET_RECRUITING
Effect of Enavogliflozin on Recurrence of Atrial Fibrillation After Catheter Ablation
Lead Sponsor:
Yonsei University
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
19-84 years
Phase:
PHASE4
Brief Summary
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 cathet...
Detailed Description
Study Design Overview: * Single-center, prospective, randomized controlled, double-blind study. * Patients who consent will be randomly assigned to either the intervention or control group. * The int...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 recurrence-free for 2-3 years.
- 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
Key Trial Info
Start Date :
August 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 5 2026
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT06528262
Start Date
August 6 2024
End Date
August 5 2026
Last Update
July 30 2024
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea