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Effect of vascular remodeling under uric acid control by xanthine oxidase inhibitor , febuxostat

Effect of vascular remodeling under uric acid control by xanthine oxidase inhibitor , febuxostat - Effect of vascular remodeling under uric acid control

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017677
Enrollment
30
Registered
2016-11-14
Start date
2015-06-01
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

Interventions

Febuxostat group (patients receiving febuxostat) Control group (patients not receiving febuxostat)

Sponsors

Department of Cardiology Osaka Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients aged >=20 years at the time informed consent is obtained (both sexes) 2) Patients with asymptomatic hyperuricemia with serum uric acid >7.0 mg/dL 3) Patients with the maximum IMT >=1.1 mm 4) Patients who gave written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Percentage change in FGF23/Klotho associated factors after 24 months from baseline as measured by carotid ultrasound imaging

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactYumiko Kanzaki

Osaka Medical College Department of Cardiology

in3089@poh.osaka-med.ac.jp072-683-1221

Outcome results

None listed

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