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.
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