Hyperuricemia is an additional risk factor for cardiovascular disease, associating with left ventricular diastolic dysfunction in individuals with metabolic syndrome. The effect of urate-lowering therapies on left ventricular diastolic dysfunction remains unclear. The study is conducted to investigate whether febuxostat or benzbromarone might improve left ventricular diastolic dysfunction in individuals with metabolic syndrome and hyperuricemia
Between 1, July 2018 and 31, Dec 2018, consecutive individuals with metabolic syndrome hyperuricemia are candidates of the present study. After the eligible candidates sign the informed consent, they will receive blood tests with a fasting time of 8 hours at least. The investigators will randomize the study participants by pre-specified random codes with a 1:1:1 ratio to the three groups. The study medication, febuxostat or benzbromarone, will be administered orally on the next day after transthoracic echocardiography is performed. The control group will only receive dietary control. All participant will receive transthoracic echocardiography and blood tests at baseline and at 3 months. The visit will be scheduled at baseline and at the 3rd month. The blood tests include high-sensitivity C-reactive protein, high-sensitivity interleukin-1 beta, high-sensitivity interleukin-6, tumor necrosis factor alpha, Dickkopf-related protein 3, galectin-3, ST2, fibroblast growth factor 23, xanthine oxidase activity, and thioredoxin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Febuxostat 40 mg orally per day plus dietary control only
Benzbromarone 50mg orally per day plus dietary control only
Dietary control only
Tri-service General Hospital, songshan branch
Taipei, Songshan Dist., Taiwan
RECRUITINGChange of average E/e'
the mean change of average E/e' in each group
Time frame: At day1 and at week 12
Difference of average E/e'
the mean difference of average E/e' between among three groups
Time frame: At day1 and at week 12
Automate office blood pressure (AOBP)
the mean difference of AOBP among three groups
Time frame: At day1 and at week 12
Change of xanthine oxidase activity
the mean change of xanthine oxidase activity in each group
Time frame: At day1 and at week 12
Difference of xanthine oxidase activity
the mean difference of xanthine oxidase activity among three groups
Time frame: At day1 and at week 12
Change of left ventricular mass index
the mean change of left ventricular mass index in each group
Time frame: At day1 and at week 12
Difference of left ventricular mass index
the mean difference of left ventricular mass index among three groups
Time frame: At day1 and at week 12
Change of tumor necrosis factor alpha
the mean change of tumor necrosis factor alpha in each group
Time frame: At day1 and at week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Difference of tumor necrosis factor alpha
the mean difference of tumor necrosis factor alpha among three groups
Time frame: At day1 and at week 12
Change of high-sensitivity interleukin-6
the mean change of high-sensitivity interleukin-6 in each group
Time frame: At day1 and at week 12
Difference of high-sensitivity interleukin-6
the mean difference of high-sensitivity interleukin-6 among three groups
Time frame: At day1 and at week 12
Change of thioredoxin
the mean change of Thioredoxin in each group
Time frame: At day1 and at week 12
Difference of Thioredoxin
the mean difference of Thioredoxin among three group
Time frame: At day1 and at week 12
Change of fibroblast growth factor 23
the mean Change of fibroblast growth factor 23 in each group
Time frame: At day1 and at week 12
Difference of fibroblast growth factor 23
the mean difference of fibroblast growth factor 23 among three groups
Time frame: At day1 and at week 12
Change of Dickkopf-related protein 3
the mean change of Dickkopf-related protein 3 in each group
Time frame: At day1 and at week 12
Difference of Dickkopf-related protein 3
the mean difference of Dickkopf-related protein 3 among three groups
Time frame: At day1 and at week 12
Change of galectin-3
the mean change of galectin-3 in each group
Time frame: At day1 and at week 12
Difference of galectin-3
the mean difference of galectin-3 among three groups
Time frame: At day1 and at week 12
Change of ST2
the mean change of ST2 in each group
Time frame: At day1 and at week 12
Difference of ST2
the mean difference of ST2 among three groups
Time frame: At day1 and at week 12