The Blood Pressure Effects of Febuxostat in Patients Previously Treated With Allopurinol: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- BP Differences While on Allopurinol and Febuxostat by Clinic Blood Pressure Readings and 24-hour Ambulatory Blood Pressure Readings
研究概览
简要总结
Hyperuricemia (high uric acid level) has been correlated to hypertension (high blood pressure) and overall cardiovascular disease risk in several studies. The relationship has even been noted to be independent of metabolic syndrome and kidney function. It has been repeatedly noted that hyperuricemia was an independent risk factor of death in those at high cardiovascular disease risk. A recent review concluded that there is strong evidence that hyperuricemia and gout are coupled with atherosclerosis and cardiovascular events.
Although this correlation of hypertension and hyperuricemia is known, there has only been one published study that has evaluated if lowering the uric acid would reduce the blood pressure. The authors concluded that in newly diagnosed hypertensive adolescents, allopurinol decreased the blood pressure. Despite this, further evaluation of this therapeutic approach has not been studied.
The hypothesis of this study is that febuxostat, a new xanthine oxidase inhibitor, has blood pressure lowering effects superior to allopurinol in patients diagnosed with gout.
详细描述
Screening and Recruitment
- Identify and recruit 20 participants from the University of Mississippi Medical Center General Internal Medicine/Hypertension and Family Medicine Clinics.
- Participants must be currently taking allopurinol for the treatment of gout and be on a stable dose of allopurinol for at least 2 months.
- Any antihypertensive medications must be at stable doses for at least 2 months.
- The identified patients will be invited to participate in the study.
Provide Consent
- IRB approved comprehension survey will be administered to participants in determination of competency to provide consent.
- The "Consent to Participate in Research" information will be discussed with each participant and consent acquired.
- Materials can be taken by the potential participant to review and consent provided at a later date.
Data collection
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients currently treated at the University of Mississippi Medical Center General Internal Medicine/Hypertension or Family Medicine Clinics.
- •Have a diagnosis of gout.
- •Taking allopurinol at a stable dose for at least 2 months.
排除标准
- •Less than 18 years old.
- •Severe renal impairment defined as CrCl <30 mL/min.
- •Previous diagnosis of severe hepatic impairment.
- •Currently taking azathioprine, mercaptopurine, or theophylline.
- •Pregnant, breastfeeding, or anticipating pregnancy or breastfeeding.
- •Arm circumference greater than 50 cm.
- •Change in antihypertensive medication within the previous 2 months.
研究组 & 干预措施
Allopurinol, febuxostat
Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.
干预措施: febuxostat (Drug)
结局指标
主要结局
BP Differences While on Allopurinol and Febuxostat by Clinic Blood Pressure Readings and 24-hour Ambulatory Blood Pressure Readings
时间窗: 4 to 5 weeks
The data collected will be analyzed and categorized according to age, race, gender, weight, height, 24-hour ABPM (24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and the mean nighttime SBP/SBP). Clinic systolic and diastolic BP and 24-hour AMBPs will be compared between the two treatments.
次要结局
- If Patients With Hypertension Receive a Greater Reduction in Blood Pressure (BP) While on Febuxostat (Versus Allopurinol)(Participants will be followed for an expected average of 4 to 5 weeks.)
研究者
Deborah Minor
Pharm D
University of Mississippi Medical Center