Wright J T, Kusek J W, Toto R D, Lee J Y, Agodoa L Y, Kirk K A, Randall O S, Glassock R
NIDDK, NIH, Bethesda, MD 20892-6600, USA.
Control Clin Trials. 1996 Aug;17(4 Suppl):3S-16S. doi: 10.1016/s0197-2456(96)00081-5.
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/ 1.73m2 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 < or = 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.
高血压和终末期肾病（ESRD）是美国发病和死亡的主要原因，在非裔美国人中尤为如此。非裔美国人肾病与高血压研究（AASK）试点研究评估了开展一项长期临床试验的可行性，该试验旨在比较两种血压控制水平和三种不同抗高血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）下降速率的影响。年龄在18至70岁、GFR为25至70 ml/min/1.73m²且患有高血压的非裔美国男性和女性，按照3×2析因设计随机分为初始治疗组，分别接受血管紧张素转换酶抑制剂（依那普利）、钙通道阻滞剂（氨氯地平）或β受体阻滞剂（阿替洛尔）治疗，且平均动脉血压（目标MAP）分别为102 - 107 mmHg或≤92 mmHg。依次添加呋塞米、多沙唑嗪、可乐定、肼屈嗪和米诺地尔，直至达到目标MAP。为了将肾病的病理诊断与临床诊断进行比较，还要求没有禁忌证的研究参与者进行肾活检。AASK试点研究的目标是评估招募技术、对规定抗高血压药物方案的依从性、抗高血压方案实现血压目标的能力、参加预定门诊就诊和检查的比率以及GFR测量的变异性。另一个目标是在至少75%的随机分组研究参与者中获取肾活检数据。与由高血压引起肾病的ESRD患者群体相比，女性在AASK试点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非裔美国人，收入水平低于美国普通非裔美国人。
