AFRICAN AMERICAN STUDY OF KIDNEY DISEASE & HYPERTENSION

这份意见书涉及在纽约市拟建的一个临床中心。 目标人口将100%是黑人，至少30%是女性或男性。 这项全面试验是一项多中心、前瞻性、双盲、 三种降压药疗效的随机对照研究 每个方案都有不同的初始随机药物和两种治疗方案 不同血压水平(BP)对肾脏保存的影响 非洲人肾小球滤过率(GFR)决定的功能 患有高血压和肾功能减退的美国人。这项研究将 采用三乘二析因设计。将有三种药物方案 使用不同的一线药物(钙通道阻滞剂，一种血管紧张素 转换酶抑制剂和β-受体阻滞剂)，将有两个 由平均动脉压(MAP)定义的目标血压水平。这些 一个小组和一张地图的目标将被映射为等于或小于92毫米汞柱 另一个在102-107毫米汞柱之间。建议的研究将会进行。 在14个临床中心和1个协调中心超过84个月。 该计划是在纽约中心对至少65名研究参与者进行随机调查 有三个来源。我们可以很容易地将参与者增加到100人，如果 需要的。我们预计从每个来源招募20-25名患者。 据了解，研究将分三个阶段进行：1. 参与者招募：24个月；2.干预和随访：48 3.研究结束和数据分析：12个月。这个 降压治疗将在随机后立即开始。 后续程序，包括测量血压和肾小球滤过率， 将在48个月的随访期内进行。为期12个月的 期间将用于关闭临床中心、数据分析和 报告结果。所有数据将集中提交并访问 数据和发布将由议定书中定义的机制(S)进行。 将集中分析异硫氰酸酯的清除情况。一种改良的体格检查 诊所医学博士的检查，以及完整的血液化学，尿液 分析包括清晨尿沉渣、心电和 肾小球滤过率测量、生活质量问卷和全科医学 历史将会被获取。这项研究将解决如何 预防或延缓与高血压相关的终末期肾病 非裔美国人。

This submission deals with a proposed clinical center in New York City. The target population will be 100% Black and at least 30% female or male. The full-scale trial is a multi-center, prospective, double-blinded, randomized study examining the effect of three antihypertensive drug regimens each with different initial randomized drugs and treatment to two different levels of blood pressure (BP) on the preservation of renal function determined by glomerular filtration rate (GFR) in African Americans with hypertension and reduced renal function. The study will have a three by two factorial design. There will be three drug regimens with differing first line drugs, (calcium channel blocker, an angiotensin converting enzyme inhibitor, and a beta-blocker) and there will be two levels of goal BP as defined by the mean arterial pressure (MAP). These goals will be MAP equal to or less than 92 mm Hg for one group and a MAP between 102-107 mmHg for the other. The proposed study will be conducted in fourteen clinical centers and one coordinating center over 84 months. The plan is to randomize at least 65 study participants at the N.Y. Center from three sources. We can easily increase this to 100 participants if needed. We expect to recruit 20-25 patients from each source. It is understood that the study will be conducted in three phases: 1. Participant Recruitment: 24 months; 2. Intervention and Follow-up: 48 months; 3. Study Close-Out and Data Analysis: 12 months. The antihypertensive therapy will be begun immediately post-randomization. Follow-up procedures, including measurement of blood pressure and GFR, will be carried out during a follow-up period of 48 months. A 12-month period will be used for close-out of Clinical Centers, data analysis, and reporting of results. All data will be submitted centrally and access to data and publications will be by the mechanism(s) defined in the protocol. Iothalamate clearances will be analyzed centrally. A modified physical exam by the clinic M.D. as well as complete blood chemistries, urine analysis including an early morning urine for sediment, ECG, and measurement of GFR, quality of life questionnaire, and general medical history will be obtained. The study will resolve questions of how to prevent or delay end stage renal disease related to hypertension in African Americans.