Urate Lowering Therapies and Left Ventricular Diastolic Dysfunction
- Conditions
- Metabolic SyndromeHyperuricemiaLeft Ventricular Diastolic Dysfunction
- Interventions
- Registration Number
- NCT03534037
- Lead Sponsor
- National Defense Medical Center, Taiwan
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
Not provided
- pregnancy
- hypersensitivity to febuxostat or benzbromarone
- acute gout
- a history of urinary tract stone
- chronic kidney disease stage IV or V
- valvular heart disease with moderate or severe regurgitation
- left ventricular ejection fraction of 40% or less
- hypertrophic cardiomyopathy or dilated cardiomyopathy or infiltrative cardiomyopathy or constrictive cardiomyopathy
- a history of congenital heart disease
- a history of pulmonary hypertension
- chronic atrial fibrillation or significant arrhythmia
- a history of intracardiac device implantation
- uncontrolled hypertension (systolic blood pressure > 160mm Hg or diastolic blood pressure > 100 mm Hg)
- alanine Aminotransferase > 3 times upper limit)
- acute infection
- suspected or diagnosed with malignancy
- a history of autoimmune disease
- limited to or dependent on daily activities
- life expectancy less than a year
- Acute coronary syndrome or received a percutaneous coronary intervention or received a coronary artery graft bypass surgery or stroke within 3 months
- Diabetes with insulin treatment or glucagon-like peptide 1 receptor agonist treatment
- Anemia (hemoglobin < 11 mg/dl in mem or <10mg/dl in women)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Control Dietary control only Benzbromarone 50mg Benzbromarone 50mg Benzbromarone 50mg orally per day Febuxostat 40mg Febuxostat 40 mg Febuxostat 40mg orally per day
- Primary Outcome Measures
Name Time Method Change of average E/e' At day1 and at week 12 the mean change of average E/e' in each group
Difference of average E/e' At day1 and at week 12 the mean difference of average E/e' between among three groups
Automate office blood pressure (AOBP) At day1 and at week 12 the mean difference of AOBP among three groups
- Secondary Outcome Measures
Name Time Method Change of xanthine oxidase activity At day1 and at week 12 the mean change of xanthine oxidase activity in each group
Difference of xanthine oxidase activity At day1 and at week 12 the mean difference of xanthine oxidase activity among three groups
Change of left ventricular mass index At day1 and at week 12 the mean change of left ventricular mass index in each group
Difference of left ventricular mass index At day1 and at week 12 the mean difference of left ventricular mass index among three groups
Change of tumor necrosis factor alpha At day1 and at week 12 the mean change of tumor necrosis factor alpha in each group
Difference of tumor necrosis factor alpha At day1 and at week 12 the mean difference of tumor necrosis factor alpha among three groups
Change of high-sensitivity interleukin-6 At day1 and at week 12 the mean change of high-sensitivity interleukin-6 in each group
Difference of high-sensitivity interleukin-6 At day1 and at week 12 the mean difference of high-sensitivity interleukin-6 among three groups
Change of thioredoxin At day1 and at week 12 the mean change of Thioredoxin in each group
Difference of Thioredoxin At day1 and at week 12 the mean difference of Thioredoxin among three group
Change of fibroblast growth factor 23 At day1 and at week 12 the mean Change of fibroblast growth factor 23 in each group
Difference of fibroblast growth factor 23 At day1 and at week 12 the mean difference of fibroblast growth factor 23 among three groups
Change of Dickkopf-related protein 3 At day1 and at week 12 the mean change of Dickkopf-related protein 3 in each group
Difference of Dickkopf-related protein 3 At day1 and at week 12 the mean difference of Dickkopf-related protein 3 among three groups
Change of galectin-3 At day1 and at week 12 the mean change of galectin-3 in each group
Difference of galectin-3 At day1 and at week 12 the mean difference of galectin-3 among three groups
Change of ST2 At day1 and at week 12 the mean change of ST2 in each group
Difference of ST2 At day1 and at week 12 the mean difference of ST2 among three groups
Trial Locations
- Locations (1)
Tri-service General Hospital, songshan branch
🇨🇳Taipei, Songshan Dist., Taiwan