AFRICAN AMERICAN STUDY OF KIDNEY DISEASE AND HYPERTENSIO

描述(直接从应用程序中获取) 非裔美国人患有高血压(HTN)和 HTN相关终末期肾病(HTN-ESRD)。但不断增加的是 大量不确定的证据表明某些类型的抗HTN 药物治疗和血压控制在比现在更低的水平 临床上正常，可能优先延缓病情进展 肾功能不全，从而延缓或预防HTN的发病- ESRD。回应RFA-DK-94-03(非裔美国人肾脏研究 高血压疾病：全面试验)来自约翰斯的研究人员 霍普金斯卫生机构提议合作开展一项 旨在测试两种药物的比较疗效的全面临床试验 三种药物方案(基于β受体阻滞剂、血管紧张素转换 酶抑制剂和钙通道阻滞剂治疗)和两个水平 血压控制(平均动脉压低于92 与102-107毫米汞柱相比)。 这项拟议的研究将是一项双盲临床试验。这项研究 人口(100%非裔美国人)将由高血压患者组成 年龄在18到70岁之间的男性和女性，他们有一个平均的肾小球 滤速(GFR)在25至70毫升/分钟/1.73米之间 平方(M2)和高血压相关肾脏的推定诊断 不够用。最少将有65人参加，并 在两年的时间里随机进行。他们将被跟踪根据 协议期约为4-6年，并已关闭 发生在公元07年。随机化后，参与者将被 每月查看一次，并将定期进行实验室评估，包括 肾清除量125测定肾小球滤过率 碘(I)-每季度一次的硫代氨基甲酸酯。主要结果将是 随访期间肾小球滤过率的变化。 申请人认为本申请的优点是多方面的- 具有公认的流行病学专业知识的学科研究团队 和治疗方面的HTN和HTN-ESRD；在 设计、实施和分析协作临床试验，包括 以参与AASK可行性试验为基础的专门知识； 参加约翰·霍普金斯大学门诊综合临床研究 中心；在招聘非裔美国人方面有良好的业绩记录 参与由美国国立卫生研究院支持的抗HTN治疗的临床试验。

DESCRIPTION (taken directly from the application) African-Americans suffer disproportionately from hypertension (HTN) and HTN-related end-stage renal disease (HTN-ESRD). An increasing but inconclusive body of evidence suggests that certain types of anti-HTN drug therapy and control of blood pressure to a lower level than is normal in clinical practice, may preferentially retard the progression of renal insufficiency and thereby delay or prevent the onset of HTN- ESRD. In response to RFA-DK-94-03 (African-American Study of Kidney Disease in Hypertension: Full Scale Trial) investigators from the Johns Hopkins Health Institutions propose to collaborate in the conduct of a full-scale clinical trial designed to test the comparative efficacy of three drug regimens (based on beta blocker, angiotensin converting enzyme inhibitor, and calcium channel blocker treatment) and two levels of blood pressure control (mean arterial blood pressure less than 92 versus 102-107 mmHg). The proposed study will be a double-blind clinical trial. The study population (100 percent African American) will consist of hypertensive men and women between the ages of 18 and 70, who have a mean glomerular filtration rate (GFR) between 25 and 70 milliliter (ml)/minute/1.73 meter squared (m2) and a presumed diagnosis of hypertension-related renal insufficiency. A minimum of 65 participants will be enrolled and randomized over a period of two years. They will be followed according to protocol for a period of approximately 4-6 years with close-out occurring in year 07. Following randomization, participants will be seen monthly and will have periodic laboratory evaluations including measurement of glomerular filtration rate by renal clearance of 125 iodine (I)-iothalamate on a quarterly basis. The primary outcome will be change in GFR during follow-up. The applicant considers strengths of this application to be a multi- disciplinary research team with acknowledged expertise in epidemiologic and therapeutic aspects of HTN and HTN-ESRD; extensive experience in the design, conduct, and analysis of collaborative clinical trials including special expertise based on participation in the AASK feasibility trial; participation of the Johns Hopkins Outpatient General Clinical Research Center; and a proven track record in the recruitment of African-American participants in NIH-supported, clinical trials of anti-HTN therapy.