The Cardiovascular Effects of Febuxostat and Benzbromarone on Left Ventricle Diastolic Dysfunction in Individuals With Metabolic Syndrome and Hyperuricemia - an Open-label Non-blinded Randomized-controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change of average E/e'
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •hypersensitivity to febuxostat or benzbromarone
- •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)
研究组 & 干预措施
Febuxostat 40mg
Febuxostat 40mg orally per day
干预措施: Febuxostat 40 mg (Drug)
Benzbromarone 50mg
Benzbromarone 50mg orally per day
干预措施: Benzbromarone 50mg (Drug)
Control
Dietary control only
干预措施: Control (Other)
结局指标
主要结局
Change of average E/e'
时间窗: At day1 and at week 12
the mean change of average E/e' in each group
Difference of average E/e'
时间窗: At day1 and at week 12
the mean difference of average E/e' between among three groups
Automate office blood pressure (AOBP)
时间窗: At day1 and at week 12
the mean difference of AOBP among three groups
次要结局
- Change of xanthine oxidase activity(At day1 and at week 12)
- Difference of xanthine oxidase activity(At day1 and at week 12)
- Change of left ventricular mass index(At day1 and at week 12)
- Difference of left ventricular mass index(At day1 and at week 12)
- Change of tumor necrosis factor alpha(At day1 and at week 12)
- Difference of tumor necrosis factor alpha(At day1 and at week 12)
- Change of high-sensitivity interleukin-6(At day1 and at week 12)
- Difference of high-sensitivity interleukin-6(At day1 and at week 12)
- Change of thioredoxin(At day1 and at week 12)
- Difference of Thioredoxin(At day1 and at week 12)
- Change of fibroblast growth factor 23(At day1 and at week 12)
- Difference of fibroblast growth factor 23(At day1 and at week 12)
- Change of Dickkopf-related protein 3(At day1 and at week 12)
- Difference of Dickkopf-related protein 3(At day1 and at week 12)
- Change of galectin-3(At day1 and at week 12)
- Difference of galectin-3(At day1 and at week 12)
- Change of ST2(At day1 and at week 12)
- Difference of ST2(At day1 and at week 12)
研究者
Cheng-Wei Liu
Principal investigator
National Defense Medical Center, Taiwan