AFRICAN AMERICAN STUDY OF KIDNEY DISEASE IN HYPERTENSION

非裔美国人对高血压肾病的研究

• 批准号: 6664773
• 负责人: STEPHEN G ROSTAND
• 金额: $ 13.85万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-08-19 至 2003-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6664773
• 关键词: ACE inhibitors; African American; alpha antiadrenergic agent; antihypertensive agents; blood pressure; calcium channel blockers; cardiovascular disorder chemotherapy; chronic renal failure; clinical trials; clonidine; cooperative study; furosemide; glomerular filtration rate; human subject; human therapy evaluation; hydralazine; hypertension; kidney disorder diagnosis; minoxidil

The first goal of this application is to initiate a Clinical Center for the Full Scale phase of the "African-American Study of Kidney Disease and Hypertension". This study is a cooperative, multicenter, prospective, double-masked, randomized study that will follow a three by two factorial design. This study will be limited to about 900 African-Americans recruited from 14 Clinical Centers. Eligibility for participation will be determined by strict inclusion and exclusion criteria. Only those with seated diastolic blood pressure equal to or more than 95 mmHg and with glomerular filtration rate (GFR) 25 - 70 mmHg/1.73m2, without malignant hypertension or systemic disease and who are willing to cooperate will be considered. This study will consist of three phases: (l) Recruitment (24 months); (2) Intervention and follow-up (45 months); (3) Data analysis, close-out, results reporting (12 months). The second goal of this study is to test whether one of three different initial randomized drugs: angiotensin converting enzyme inhibitor (ACEi), calcium channel blocker (CCB) or beta blocker. better reduces the rate of decline of UFR in African-Americans with renal insufficiency attributed to hypertension. A third goal is to examine if one of two levels of blood pressure control (equal to or less than 92 mmHg vs. 102-107 mmHg, mean arterial pressure) is better at preserving renal function. Assignment to treatment and blood pressure groups will be randomized and the treatment regimen will be double-masked. Subsequent to assignment. no other ACEis, CCBs or beta- blockers will be used. If a blood pressure goal is not reached in a participant on maximal doses of the assigned drugs, additional antihypertensives will be used in the following order: (l) diuretics (furosemide); (2) alpha-blocker (doxazosin); (3) central alpha2 agonist (clonidine); (4) minoxidil or hydralazine. This study has major health related implications for disease prevention in that it will try to examine if renal failure due to hypertension that occurs in an extremely high risk African-American population can be slowed or prevented, thereby reducing the need for dialysis and renal transplantation.

该应用程序的第一个目标是启动一个临床中心 “非裔美国人肾脏疾病研究和 高血压”。这项研究是一项合作，多中心，前瞻性， 双掩盖的随机研究将遵循三分句子 设计。这项研究将仅限于约900名非裔美国人 从14个临床中心招募。参与资格将是 通过严格的包容和排除标准确定。只有那些 舒张压等于或大于95 mmHg，与 肾小球滤过率（GFR）25-70 mmHg/1.73m2，没有恶性 高血压或全身性疾病以及愿意合作的人 经过考虑的。这项研究将由三个阶段组成：（l）招聘（24 几个月）; （2）干预和随访（45个月）； （3）数据分析， 结束，结果报告（12个月）。 这项研究的第二个目标是测试三种不同的 最初的随机药物：血管紧张素转化酶抑制剂（ACEI）， 钙通道阻滞剂（CCB）或β受体阻滞剂。更好地降低 肾功能不全的非裔美国人的UFR下降归因于 高血压。 第三个目标是检查是否有两个级别的血压控制 （等于或小于或小于92 mmHg与102-107 mmHg，平均动脉压） 更好地保留肾功能。分配治疗和血液 压力组将是随机的，治疗方案将是 双面具。分配之后。没有其他ACEI，CCB或Beta- 将使用阻滞剂。如果未达到血压目标 参加分配药物的最大剂量的参与者，额外 抗高血压将按以下顺序使用：（l）利尿剂 （速尿）； （2）Alpha-Blocker（Doxazosin）; （3）中央α2激动剂 （可乐定）; （4）米诺地尔或氢化嗪。 这项研究对预防疾病的健康与健康有关 它将尝试检查是否由于高血压引起的肾衰竭 发生在极高风险的非裔美国人人口中可以放慢 或阻止，从而减少了透析和肾脏的需求 移植。