None listed
Conditions
Interventions
Drug : - After a sufficient explanation of the Single center, prospective, randomized controlled, double blind study- study- patients who participated in the consent will be randomly assigned and the
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. adults between 19 and 85 years of age 2. Patients who agree to enrollment in this study and can observe the course of the study. 3. Patients with atrial fibrillation with heart failure who have undergone or are scheduled to undergo atrial fibrillation electrode catheter resection within the last three months
Exclusion criteria
Exclusion criteria: 1. Under 19 years of age or over 85 years of age 2. Patients within 3 months of completion of the other clinical trials they participated in (for the safety of the subjects and the reliability of the results of the study) 3. a person with a life expectancy of less than a year 4. a pregnant woman 5. Type 2 diabetes already being treated using SGLT-2 inhibitor 6. In the case of more than three urinary tract infections and genital infections in the past year 7. Uncontrolled hypertension: systolic blood pressure = 180 mmHg or diastolic blood pressure = 110 mmHg 8. Systolic blood pressure < 90 mmHg 9. 12 acute cardiovascular event (stroke, acute coronary syndrome (ACS), revascularization, decompensated heart failure, sustained ventricular tachycardia, return of spontaneous circulation (ROSC) 10. Severe valve disease or artificial valve 11. renal dysfunction (eGFR-CKD-EPI <60ml/min/1.73m2) 12. Clinically confirmed liver dysfunction: enavogliflozin has limited experience in patients with mild liver disorder, and it was not studied because patients with moderate and severe liver disorder were not included in the phase 3 clinical trial. Therefore, the researcher will decide whether to exclude or not by judging each subject according to the level of liver enzyme and the type and progression of the underlying liver disease. 13. Uncontrolled thyroid dysfunction 14. Patients diagnosed with overt cancer (including those under treatment) and those with a history of cancer within 5 years at the time of screening (the risk period of recurrence is usually considered 5 years): However, for borderline cancer, if it is maintained without recurrence for 2 to 3 years after successful treatment, there is little risk of recurrence and is not subject to study as a mitigation condition: Dietary intake may be insufficient, which may increase the frequency of hypoglycemia, ketoacidosis, and weight loss caused by enavoglifluozin administration. 15. Continuous use of steroid preparations equivalent to or greater than oral prednisolone 10 mg/day within the last month 16. Patients who have a history of hypersensitivity and hypersensitivity to the main ingredient of this drug or its components 17. Type 1 diabetic or diabetic ketoacidosis patients 18. history of alcohol and substance abuse 19. Pregnant women who did not agree to appropriate contraception methods during the clinical trial - Appropriate contraception methods: Hormonal contraceptives, intrauterine devices, blocking contraception (male or female) and simultaneous use of apricots, surgical infertility procedures and surgeries (barectomy, tubectomy and ligation, hysterectomy) *Drug-related criteria being administered for the purpose of treating atrial fibrillation or underlying disease with heart failure: In principle, there is no combination suppression drug. However, the risk of decreased blood volume or hypotension may increase due to the additional diuretic action of enavogliflozin in patients using diuretics. Before starting drug administration, we will evaluate the fluid volume and kidney function, guide the appropriate hydration, and monitor the symptoms and signs of hypotension and renal function after starting administration. In the event of abnormalities such as dehydration and blood pressure reduction, appropriate treatment such as discontinuation of drug administration and fluid supplementation will be performed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In subjects with 12-month follow-up or recurrence of atrial fibrillation (FAS), check if there is a difference in the atrial fibrillation recurrence rate (AF current) from 3 months to 1 year after electrode catheter resection between the experimental group (enavogliflozin-administered group) and the control group (placebo-administered group) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Total burden of atrial fibrillation confirmed by halter (wearable patch electrocardiogram) test after electrode catheter resection (total AF burden, %) - time to first AFRECURENCE after electrode catheter resection - Heart failure hospitalization due to heart failure after electrode catheter resection - AF Symptom score (mEHRA) - Quality of life (AFEQT) - Rate of change in metabolic indicators: glycated hemoglobin, body weight, insulin resistance (HOMA-IR), ketone body, fatty liver indicators - hypoglycemia incidence - incidence of diabetic ketoacidosis - incidence of genitourinary infection - Comparison of the reduction rate of NT-pro BNP - Sub-analysis of diabetic patients: rate of change in the above mentioned metabolic indicators, rate of occurrence of hypoglycemia, change in fasting blood sugar, recurrence rate of atrial fibrillation up to 1 year after electrode catheter resection, etc | — |
Countries
Korea, Republic of
Contacts
Public ContactLee Yong-ho
Yonsei University
Outcome results
None listed