Design and baseline characteristics of participants in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study
Design and baseline characteristics of participants in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study
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DOI：
10.1016/s0197-2456(96)00081-5
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发表时间：
1996-08-01
期刊：
影响因子：
--
通讯作者：
Glassock, R
中科院分区：
文献类型：
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作者：
Wright, JT;Kusek, JW;Glassock, R
高血压和终末期肾病（ESRD）是美国发病率和死亡率的主要原因，特别是在非洲裔美国人中。非裔美国人肾病和高血压研究（AASK）初步研究评价了进行长期临床试验的可行性，以比较两种血压控制水平和三种不同的降压药物方案对临床诊断为高血压肾病的非裔美国人肾小球滤过率（GFR）下降率的影响。年龄在18 - 70岁、GFR为25 - 70 ml/min/1.73m2、患有高血压的非裔美国男性和女性，采用3 × 2析因设计，随机接受血管紧张素转换酶抑制剂（依那普利），钙通道阻滞剂（AIV）或β受体阻滞剂（阿替洛尔），并且平均动脉血压（目标MAP）为102 - 107 mm Hg或小于或等于92 mm Hg。依次加入呋塞米、多沙唑嗪、可乐定、肼苯哒嗪和米诺地尔，直至达到目标MAP。为了比较肾脏疾病的病理诊断与临床诊断，还要求无禁忌症的研究参与者进行肾活检。AASK初步研究的目的是评价招募技术、对处方降压药物方案的依从性、降压方案实现血压目标的能力、计划的临床访视和程序的参与率以及GFR测量的变异性。进一步的目标是获得至少75%的随机研究参与者的肾活检数据。与由高血压引起的肾病的ESRD患者人群相比，女性在AASK初探性研究中的代表性不足。AASK试点研究参与者的失业率高于美国普通人口中的非洲裔美国人，收入水平较低。
Hypertension and end-stage renal disease (ESRD) are major causes of morbidity and mortality in the United States, especially among African Americans. The African American Study of Kidney Disease and Hypertension (AASK) Pilot Study evaluated the feasibility of conducting a long-term clinical trial to compare the effects of two levels of blood pressure control and three different antihypertensive drug regimens on the rate of decline in glomerular filtration rate (GFR) in African Americans with clinically diagnosed hypertensive renal disease. African American men and women aged 18-70 years with a GFR of 25-70 ml/min/1.73m(2) and hypertension were randomized in a 3 x 2 factorial design to initial treatment with either an angiotensin-converting enzyme inhibitor (enalapril), a calcium channel blocker (amlodipine), or a beta blocker (atenolol) and to a mean arterial blood pressure (goal MAP) of either 102-107 mm Hg or less than or equal to 92 mm Hg. Furosemide, doxazosin, clonidine, hydralazine, and minoxidil were added sequentially until goal MAP was achieved. To compare the pathologic diagnosis with the clinical diagnosis of renal disease, study participants without contraindication were also asked to undergo a renal biopsy. The goals of the AASK Pilot Study were to evaluate recruitment techniques, adherence to prescribed antihypertensive drug regimens, ability of the antihypertensive regimens to achieve blood pressure goals, rates of participation in scheduled clinic visits and procedures, and variability of GFR measurements. A further goal was to obtain renal biopsy data in at least 75% of the randomized study participants. Compared to the ESRD patient population whose renal disease is caused by hypertension, women were underrepresented in the AASK Pilot Study. AASK Pilot Study participants had higher unemployment rates and lower income levels than African Americans in the general U.S. population.