AFRICAN AMERICAN STUDY OF KIDNEY DISEASE & HYPERTENSION

本次申报涉及纽约市的一家拟定临床中心。 目标人群将是100%黑人和至少30%女性或男性。 全面试验是一项多中心、前瞻性、双盲、 三种抗高血压药物疗效的随机研究 每个方案都有不同的初始随机药物和治疗， 不同血压水平对肾功能的保护作用 非洲人肾小球滤过率（GFR）测定的功能 患有高血压和肾功能下降的美国人。这项研究将 是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，血管紧张素 转化酶抑制剂，和β-受体阻滞剂），将有两个 由平均动脉压（MAP）定义的目标BP水平。这些 目标是一组MAP等于或小于92 mm Hg， 另一个在102-107 mmHg之间。拟议的研究将在 在14个临床中心和1个协调中心，为期84个月。 该计划将在纽约随机抽取至少65名研究参与者。中心 从三个来源。我们可以很容易地增加到100名参与者， needed.我们希望从每个来源招募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。的 将在随机化后立即开始抗高血压治疗。 随访程序，包括测量血压和GFR， 将在48个月的随访期内进行。12个月 期间将用于临床中心关闭、数据分析和 报告结果。所有数据都将集中提交， 数据和出版物将由议定书规定的机制提供。 将集中分析碘酞酸盐清除率。改性的物理 临床医学博士的检查以及血液生化和尿液 分析包括晨尿沉渣、ECG和 GFR测量、生活质量问卷和一般医疗 历史将被获得。这项研究将解决如何 预防或延迟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.