Effect of vascular remodeling under uric acid control by xanthine oxidase inhibitor , febuxostat
- Conditions
- Hyperuricemia
- Registration Number
- JPRN-UMIN000017677
- Lead Sponsor
- Department of Cardiology Osaka Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 30
Not provided
1) Patients being treated with any of the following antihyperuricemic agents within 8 weeks before confirmation of the eligibility criteria: Allopurinol, benzbromarone, probenecid, bucolome, topiroxostat, febuxostat 2) Patients being treated with any of the following agents at the time of confirmation of the eligibility criteria: Mercaptopurine hydrate, azathioprine, vidarabine, didanosine 3) Patients who have undergone an operation or who have severe infections or serious injury at the time of confirmation of the eligibility criteria 4) Patients who had myocardial infarction, angina pectoris, percutaneous transluminal coronary angioplasty/bypass surgery, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient cerebral ischemic attack within 3 months before confirmation of the eligibility criteria 5) Patients with cardiac dysfunction (NYHA class IV) 6) Patients with gouty tophus, or those who have subjective symptoms of gout arthritis within 1 year before confirmation of the eligibility criteria 7) Patients with severe renal dysfunction (eGFR <30 mL/min or patients under dialysis) 8) Patients with severe liver dysfunction (AST or ALT <=2 times the upper limit of the institutional standard value) 9) Patients with a complication or a disease history (e.g. malignant tumor) who are considered not eligible for the study by the attending doctor 10) Patients with a history of hypersensitivity to febuxostat 11) Pregnant, possibly pregnant, or lactating women or those who wish to become pregnant during participation in the study 12)Patients who underwent CEA or CAS surgery 13) Patients who are considered not eligible for the study by the attending doctor due to other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage change in FGF23/Klotho associated factors after 24 months from baseline as measured by carotid ultrasound imaging
- Secondary Outcome Measures
Name Time Method 1) FGF23/Klotho associated factors (FGF21,FGF19 etc), Parathyroid hormone levels at baseline, after 6 months, 12 months, and 24 months, and the amount of change and %change from baseline 2)Values of the following cardiovascular function parameters at baseline, after 12 months, and 24 months, and the amount of change and %change from baseline (arbitrary items) Echocardiography, carotid ultrasound imaging, cardiovascular examination, blood pressure, heart rate