None listed
Conditions
Interventions
Drug : In principle, the test group should administer 400 mg of dronedarone twice a day orally. However, when clinical needs, including observation of adverse reactions, occur in the subject in the te
Sponsors
Inha University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) subjects voluntarily agreed to participate in this clinical research participation 2) More than 19 years old 3) More than one year 4) After diagnosis of Shimbang-dong, it's within a year 5) an adaptive pulse system with adaptive pulse system (Dronorone or Class Ic drug) treatment
Exclusion criteria
Exclusion criteria: 1) A person with a previous history of antiarrhythmic treatment failure 2) Those with severe structural heart disease (severe left ventricular systolic dysfunction (HFrEF (EF = 40%), moderate or higher mitral valve stenosis (moderate or higher stenosis on echocardiography), mechanical valve replacement, dilated cardiomyopathy) 3) a person diagnosed with permanent atrial fibrillation 4) Severe kidney (glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² or those on dialysis) or liver function Due to failure (Child-Pugh class B or higher, ALT or AST more than three times the upper limit of normal) a person whose use of antiarrhythmic drugs is restricted 5) Anyone with contraindications for dronedarone or Class Ic antiarrhythmic drugs 6) A person who has participated in another clinical trial within three months as of the date of randomization (first dosing) 7) A person who disagrees that he/she should not participate in another clinical trial within 14 days of the end date of participation 8) Women of childbearing age who are pregnant or who have not consented to effective contraception during participation in the pregnancy test 9) Other persons deemed inappropriate to participate in clinical trials under the judgment of the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Assessment: Compare atrial fibrillation recurrence rates in Dronedarone and Class Ic antiarrhythmic agents.;Safety Assessment: Compare the percentage of drug discontinuation due to drug-related side effects of Dronedarone and Class Ic antiarrhythmic agents. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in quality of life (QoL);Medication adherence;Utilization rates of atrial fibrillation treatment options (including use of non-vitamin K antagonist oral anticoagulants (NOACs), medical therapy(rate and rhythm control), atrial fibrillation catheter ablation, and DC cardioversion), ;Incidence of other arrhythmias detected by Holter or wearable patch ECG (e.g., premature atrial contractions (PACs), premature ventricular contractions (PVCs), atrioventricular (AV) block, supraventricular tachycardia (SVT), ventricular tachycardia (VT)), ;Incidence of major adverse cardiovascular events (MACE) (defined as cardiovascular death, stroke, hospitalization for worsening heart failure, and hospitalization for acute coronary syndrome (ACS)) | — |
Countries
Korea, Republic of
Contacts
Public Contacthyerim park
Inha University Hospital
Outcome results
None listed