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DoCA-AF study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Atrial Fibrillation
Date of first enrollment	02/09/2025
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	The day after catheter ablation for atrial fibrillation, the patient is started dotinurad 0.5 mg once daily (anytime morning, noon, or evening). Medication is continued for 24 weeks. Based on daily symptoms and blood sampling results, tolerability is determined, and dosage is adjusted as needed after 4 and 12 weeks of administration (from 0.5 mg to 2 mg) so that serum uric acid levels do not fall below 2.0 mg/dl as a rule of thumb.

Outcome(s)

Primary Outcome

Amount of change in LA stiffness index (=E/e'/LA-GLS) before and after echocardiography at the day after catheter ablation and at 24 weeks after catheter ablation Amount of change = (day after catheter ablation) - (24 weeks after catheter ablation)

Secondary Outcome

Maintenance of sinus rhythm after catheter ablation Amount and rates of change in left atrial strain, left atrial diameter, left atrial volume, left ventricular ejection fraction, left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular inflow velocity waveform (E, A), mitral annular velocity waveform (e'), E/A, E/e', left ventricular long axis strain, LA stiffness index (=E/A, E/e'), and LA emptying fraction (LAEF) in echocardiogram. The rates of change in LA stiffness index (=E/e'/LA-GLS) Amount and rates of change in left atrial and left ventricular strain, left atrial volume, left ventricular volume (end diastolic volume, end systolic volume, EF), extracellular volume fraction (ECV), non-contrast myocardial T1 value, epicardial fat, and MR spectroscopy on cardiac MRI (performed under sinus rhythm) Amount and rates of change in ANP, BNP, Cre, and eGFR in laboratory tests Amount and rates of change in urinary protein, uric acid, urinary albumin, and urinary creatinine in urinalysis Amount and rates of change in cardiothoracic ratio in chest X-ray examination Amount and rates of change in blood pressure, pulse rate, and body weight Comparison of composite endpoints defined as all-cause mortality, heart failure hospitalization, and stroke. Amount of change = (day after catheter ablation) - (24 weeks after catheter ablation) Rate of change (%) = (day after catheter ablation - 24 weeks after catheter ablation) / day after catheter ablation*100 Comparative analysis with historical data will also be performed. Primary endpoints Amount of change in LA stiffness index (=E/e'/LA-GLS) on echocardiography before and after catheter ablation at the day after catheter ablation and at 24 weeks after catheter ablation. Secondary endpoints Maintenance of sinus rhythm after catheter ablation Amount and rates of change in left atrial strain, left atrial diameter, left atrial volume, left ventricular ejection fraction, left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular inflow velocity waveform (E, A), mitral annular velocity waveform (e'), E/A, E/e', left ventricular long axis strain, LA emptying fraction (LAEF), and the rate of change in LA stiffness index (=E/e'/LA-GLS). Amount and rates of change in ANP, BNP, Cre, and eGFR in laboratory tests Comparison of other composite endpoints defined as all-cause mortality, heart failure hospitalization, and stroke Amount of change = (day after catheter ablation) - (24 weeks after catheter ablation) Rate of change (%) = (day after catheter ablation - 24 weeks after catheter ablation) / day after catheter ablation*100 *The echocardiographic data for the control group (historical data) are the data between two points between the day after the ablation and one year after the ablation. (The data between data performed during the ablation hospitalization and data between 3 months and 1 year after the ablation shall be used, respectively.)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. atrial fibrillation (including paroxysmal and persistent) 2. serum uric acid level of 4.0 mg/dl or higher in both sexes on blood test within the last 3 months 3. LVEF greater than 50% on echocardiography within the last 3 months 4. scheduled to undergo initial catheter ablation 5. age 18 years or older at the time of consent 6. written consent of the study subject 7. NYHA class 1-3
Exclude criteria	1. eGFR less than 30 mL/min/1.73m2 at the time of consent 2. acute coronary syndrome, stroke, ischemic stroke, percutaneous coronary intervention (PCI), cardiovascular, carotid, or other major cardiovascular surgery within 3 months of obtaining consent 3. hospitalization for heart failure within 6 months of obtaining consent 4. atrial fibrillation more than 3 years since persistence or left atrial diameter greater than 55 mm 5. patients with implanted pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy, etc., or scheduled for such implantation during the study observation period 6. patients with diagnosed or suspected cardiac amyloidosis 7. Patients diagnosed or suspected to have hypertrophic cardiomyopathy 8. patients with advanced valvular disease 9. patients who are allergic to therapeutic agents 10. patients with unstable angina pectoris 10. Patients with unstable angina pectoris 11. patients with severe liver disease (AST (GOT) or ALT (GPT) > 100 IU/L) 12. Pregnant, possibly pregnant, or lactating patients 13. Patients who have participated in any other interventional or clinical trial within 3 months prior to the start of study drug administration (other enrollment studies are acceptable) 14. patients who are deemed inappropriate as study subjects by the principal investigator or subinvestigator 15. patients who are taking antihyperuricemic drugs within 3 months of obtaining consent