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A Single-Center Randomized Controlled Trial on the Effects of Uric Acid Treatment Intervention on Atherosclerosis and Vascular Endothelial Function in Patients with Atrial Fibrillation

A Single-Center Randomized Controlled Trial on the Effects of Uric Acid Treatment Intervention on Atherosclerosis and Vascular Endothelial Function in Patients with Atrial Fibrillation - URISAF

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1031250441
Enrollment
30
Registered
2025-10-17
Start date
2025-10-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperuricemia Hyperuricemia, Atrial fibrillation, Arteriosclerosis, Endothelial dysfunction

Interventions

Drug administration for hyperuricemia

Sponsors

Okada Kozo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 18 years of age or older 2. Patients with serum uric acid levels >7 mg/dL or currently taking urate-lowering medication 3. Patients who have undergone ablation therapy for atrial fibrillation and are maintaining sinus rhythm 4. Participants who have received sufficient explanation about the study content and have provided written consent

Exclusion criteria

Exclusion criteria: 1. Patients with concurrent active malignant tumors. 2. Patients whose acute gouty arthritis has not subsided 3. Patients currently suffering from urinary tract stones 4. Patients with known secondary hyperuricemia meeting the following criteria: Lesch-Nyhan syndrome, phosphoribosyl pyrophosphate synthetase overproduction syndrome, congenital myogenic hyperuricemia, hematologic malignancies (acute leukemia, malignant lymphoma, myeloproliferative disorders, myelodysplastic syndromes), solid tumors (breast cancer, seminoma, sarcoma, Wilms tumor, small cell lung cancer), non-neoplastic diseases (psoriasis vulgaris, secondary polycythemia, hemolytic anemia), tumor lysis syndrome, rhabdomyolysis, hypothyroidism, polycystic kidney disease, lead poisoning/lead nephropathy, Down syndrome, familial juvenile gouty nephropathy, hyperlactatemia, type I glycogen storage disease 5. Patients receiving mercaptopurine hydrate or azathioprine 6. Patients with severe hepatic impairment (Child-Pugh class C or higher) 7. Patients with severe renal impairment (eGFR < 20) presenting with oliguria or anuria, and dialysis patients 8. Patients who are pregnant, may become pregnant, or are breastfeeding 9. Patients with hypersensitivity to dothienure or febuxostat components 10. Patients for whom CAVI measurement is difficult 11. Patients deemed unsuitable for this study by the principal investigator or sub-investigator

Design outcomes

Primary

MeasureTime frame
Change rate of CAVI from baseline to week 24

Secondary

MeasureTime frame
1. Change in serum uric acid levels and percentage change at 4, 8, 12, and 24 weeks after drug administration 2. Proportion of patients achieving serum uric acid levels 30 seconds detected by Holter ECG or captured on a 12-lead ECG, 2. Use of antiarrhythmic drugs, 3. Re-ablation

Contacts

Public ContactHisaya Kondo

Division of Cardiology, Yokohama City University Medical Center

kondo.his.qs@yokohama-cu.ac.jp+81-45-261-5656

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026