AFRICAN AMERICAN STUDY OF KIDNEY DISEASE AND HYPERTENSION (AASK)

高血压是普通人群中终末期肾病（ESRD）的主要原因之一，也是黑人的头号原因。 这两种疾病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。 有一些初步证据表明，一些抗高血压药物可能会延缓高血压肾病的进展，但尚未进行临床试验来验证这一假设在非洲裔美国人，谁是不成比例地受到这种疾病的影响。 本多中心项目（已完成主动招募阶段）将比较两种水平的血压（BP）控制和三种不同的降压药物方案对18-70岁的高血压非洲裔美国人肾小球滤过率（GFR）下降率的影响，这些高血压非洲裔美国人临床诊断为高血压肾病（GFR 25- 70 ml/min/1.73msq）。试图找到答案：1）高血压肾病的病理损害是否纯粹是持续性高血压的结果？2)在保护肾功能方面，一种降压药是否优于另一种？和3）是否有一个血压水平更适合肾脏的生存，而不是一般推荐的水平140/90毫米汞柱？根据血压水平和GFR结果，合格的患者在3x 2析因设计中被随机分配到血管紧张素转换酶抑制剂（依那普利）、钙通道阻滞剂（依那普利）或α-受体阻滞剂（阿替洛尔）的初始治疗组，平均动脉血压（目标MAP）<92 mmHg或102- 107 mmHg。 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。AASK辅助研究是一项针对AASK全规模试验人群的多中心辅助研究。 研究了来自主研究的患者子集（总共300例患者或100例患者/治疗组），以检查主AASK研究中使用的三类抗高血压药物对该患者人群心率变异性（HRV）的影响。 据推测，与钙通道阻滞剂治疗相比，长期（1年）阻滞剂治疗将导致更大的副交感神经张力，这反映在患有肾脏疾病的高血压非洲裔美国人的HRV差异（通过霍尔特监测和EKG）中。 发现，它可以转化为降低发病率在这一患者群体。 主要结果测量将是通过RR间期的心跳间变异性的频谱分析测量的HRV，观察一年后标准化形式的高频分量。将在霍尔特核心实验室对所有霍尔特监测数据进行统计分析、解释和数据录入，然后提供给主要研究的中央数据处理中心。

Hypertension is one of the major causes of end-stage renal disease (ESRD) in the general population, and the number one cause in Blacks. These two diseases are the major cause of morbidity and mortality in the United States, especially among African Americans. There is some preliminary evidence suggesting that some antihypertensive drugs may retard the progression of hypertensive renal disease, but no clinical trial has been conducted to test this hypothesis in African Americans, who are disproportionately affected by this ailment. This multicenter project (active enrollment phase completed) will compare the effects of two levels of blood pressure (BP) control and three different antihypertensive drug regimens on the rate of decline in glomerular filtration rate (GFR) in hypertensive African Americans 18-70 years of age, with clinically diagnosed hypertensive renal disease (GFR 25-70ml/min/1.73msq.) to try to find answers to: 1)Is the pathological lesion in hypertensive renal disease purely a result of persistent hypertension?; 2) Is one antihypertensive drug better than another in terms of preservation of renal function?, and 3) Is there a level of BP more suitable for the survival of the kidney as opposed to the generally recommended level of 140/90mmHg? Those who qualified, based on BP levels and GFR results, were randomized in a 3x2 factorial design to initial treatment with either an angiotensin converting enzyme inhibitor (enalapril), a calcium channel blocker (amlodipine), or a -blocker (atenolol) and to a mean arterial BP (Goal MAP) of either < 92mmHg or 102-107mmHg. Furosemide, doxazosin, clonidine, hydralazine, and minoxidil are sequentially added until the goal MAP is achieved. THE AASK ANCILLARY STUDY is a multicenter, ancillary study of the AASK Full-Scale Trial population. A subset of the patients from the main study (300 total patients or 100 patients/treatment arm) are studied in order to examine the effects of the three classes of antihypertensive medications used in the main AASK Study, on heart rate variability (HRV) in this patient population. It is hypothesized that long-term (1 year) -blocker treatment will lead to greater parasympathetic tone, compared to calcium channel blocker treatment, as reflected by a difference in HRV (by Holter monitor and EKG) in hypertensive African Americans with renal disease. found, it could translate into decreased morbidity in this patient population. The primary outcome measure will be HRV as measured by spectral analysis of the beat-to-beat variability of the RR interval, looking at the high frequency component in normalized form after one year. Statistical analyses, interpretation and data entry of all Holter monitor data will be performed at the Holter Core Laboratory, and then supplied to the Central Data Processing Center for the main study.