AFRICAN AMERICAN STUDY OF KIDNEY DISEASE AND HYPERTENSIO

描述（直接取自应用程序） 非洲裔美国人患高血压（HTN）的比例不成比例， HTN相关终末期肾病（HTN-ESRD）。增长，但 一些不确定的证据表明，某些类型的抗HTN 药物治疗和控制血压的水平低于 在临床实践中正常，可能优先延缓进展 肾功能不全，从而延迟或预防HTN的发作。 终末期肾病响应RFA-DK-94-03（非裔美国人肾脏研究 高血压疾病：全规模试验）， 霍普金斯卫生机构建议合作开展一项 一项全面的临床试验，旨在测试 三种药物方案（基于β受体阻滞剂、血管紧张素转换酶 酶抑制剂和钙通道阻滞剂治疗）和两个水平 血压控制（平均动脉血压低于92 对比102-107 mmHg）。 拟定研究将是一项双盲临床试验。 研究 人群（100%非洲裔美国人）将由高血压 年龄在18岁到70岁之间的男性和女性，平均肾小球 滤过率（GFR）在25和70毫升（ml）/分钟/1.73米之间 平方（m2）和高血压相关肾脏病的假定诊断 不足 将至少招募65名参与者， 在两年的时间里随机分配。 他们将根据 方案的期限约为4-6年，直至关闭 发生在07年。 随机化后，受试者将 每月一次，并将定期进行实验室评估，包括 通过肾清除率测量肾小球滤过率125 碘（I）-碘酞酸盐，每季度一次。 主要成果将 随访期间GFR的变化。 申请人认为本申请的优势是多方面的， 具有流行病学公认专长的学科研究团队 HTN和HTN-ESRD的治疗方面; 合作临床试验的设计、实施和分析，包括 基于参与AASK可行性试验的特殊专业知识; 参加约翰霍普金斯门诊一般临床研究 中心;并在招聘非洲裔美国人的良好记录 参与NIH支持的抗HTN治疗临床试验。

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.