AFRICAN-AMERICAN STUDY OF KIDNEY DISEASE AND HYPERTENSION (AASK)

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。AASK试验是一项随机临床试验，测试了3种不同的药物（雷米普利、美托洛尔和氨氯地平）作为一线降压治疗对肾脏疾病的影响，以及2种水平的血压控制（常规控制和更积极的控制）。AASK队列研究招募了参加过AASK临床试验的受试者。暴露包括环境、遗传、生理和社会经济因素。原发性肾脏结局是由血清肌酐翻倍、终末期肾脏疾病（ESRD）或死亡确定的临床结局。在基线和之后每12个月收集一次与确定暴露和监测结果有关的数据。降压治疗的管理发生在这些就诊和额外的2至4次就诊/年。核心测量包括以下内容：血压、空腹血样、DNA、24小时尿液采集、指甲（重金属检测）、问卷调查和心血管检查（心电图、二维、m型、脉冲多普勒和脉冲组织多普勒超声心动图、24小时动态血压记录）。为所有没有ESRD的参与者提供适当的降压治疗（在AASK试验中确定的药物和目标血压水平）。通过这种方式，该队列直接控制了肾脏疾病进展的两个主要“已知”决定因素（高血压控制和肾保护、降压药物的使用），因此解决了推荐降压治疗设置中的研究问题。队列研究的预期随访时间为5年（总计9-12年，包括AASK试验期间）。一个独立的DSMB监测研究的各个方面，并审查所有不良事件。最终，来自AASK队列研究的数据应该增强我们对决定肾脏疾病进展的过程的理解。这项研究的成功完成也可能导致新的预防策略，延迟ESRD的发病。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The AASK trial was a randomized, clinical trial that tested the effects on kidney disease of 3 different medications used as first line antihypertensive therapy (ramipril, metoprolol and amlodipine) and 2 levels of blood pressure control (usual control and more aggressive control). The AASK Cohort Study enrolled subjects who had participated in the AASK clinical trial. Exposures include environmental, genetic, physiologic, and socio-economic factors. The primary renal outcome is a clinical outcome defined by doubling of serum creatinine, end-stage renal disease (ESRD) or death. Data related to ascertainment of exposures and surveillance of outcomes are collected at baseline and every 12 months thereafter. Management of antihypertensive therapy occurs at these visits and at an additional 2 to 4 visits/year. Core measurements include the following: blood pressure, fasting blood specimens, DNA, 24-hour urine collection, finger nails (for heavy metals), questionnaires and cardiovascular procedures (ECG; 2 dimensional, M-mode, pulsed Doppler and pulsed tissue Doppler echocardiogram; and 24-hour ambulatory BP recordings). Appropriate antihypertensive treatment (medications and target BP level as determined in the AASK trial) is provided to all participants who do not have ESRD. In this fashion, the cohort directly controls two of the major 'known' determinants of kidney disease progression (control of hypertension and use of reno-protective, antihypertensive medication) and therefore addresses research questions in the setting of recommended antihypertensive care. The anticipated duration of follow-up in the Cohort Study is 5 years (total of 9-12 years, including the period of the AASK trial). An independent DSMB monitors all aspects of the study, and reviews all adverse events. Ultimately, data from the AASK cohort study should enhance our understanding of the processes that determine progression of renal disease. Successful completion of this study might also lead to new prevention strategies that delay the onset of ESRD.