Influence of XOI, Febuxostat, on Vascular Function in Patients with Hyperuricemia and Cardiovascular Risk Factors

UMIN ID: UMIN000019530

Registered date:28/10/2015

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: (1) Treated or untreated hyperuricemia and (2) Hypertension, ischemic heart disease, diabetes, dyslipidemai, chronic kidney disease (CKD), history of cerebrovascular diease, aortic dissection, or metabolic syndrome
• Date of first enrollment: 2015/10/29
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Febuxostat Febuxostat will be administered from 10mg, and then increaed to 20 and 40mg, after 4wks and 8wks, respectively. Serum uric acid is measured before increasing febuxostat, and if uric acid <6.0mg/dl, febuxostat will not be increased.
Allopurinol Allopurinol will be started from 100mg/day and will be incraed to 200mg after 4 wks. Follow up period is 6 months

Outcome(s)

• Primary Outcome: Changes of flow-mediated dilatation (FMD), pulse wave velocity (PWV), central pressure, carotid intima-media thickness (IMT) at 6 months after the intervention.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) Age < 20years (2)Patients having gout attack at the time of eligibility judgment (3)Patients with renal failure, or dialysis (4)Patients with hepatic impairment (5)Patinets having malignancy, chemotherapy, psoriasis vulgaris, polycythemia, hemolytic anemia, myopathy, PRPP synthetaze activation, Lesch-Nyhan syndrome (HPRT deficiency), Diabetes insipidus, or other severe diseases (6)Patients with hypersensitivity to febuxostat (7)Treated patients with mercaptopurine or azathioprine, aciclovir, and didanosine (8)Pregnant female, lactation femal, hoping gestation (9)Patients whom study physicians consider as not eligible.

Related Information

• Primary Sponsor: Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
• Source(s) of Monetary Support: Teijin Pharma