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The Rationale and Design of the AASK Cohort Study

Lawrence J. Appel^*, John Middleton, Edgar R. Miller, III^*, Michael Lipkowitz, Keith Norris, Lawrence Y. Agodoa^¶, George Bakris^**, Janice G. Douglas, Jeanne Charleston^*, Jennifer Gassman, Tom Greene, Kenneth Jamerson, John W. Kusek^¶, Julia A. Lewis^¶¶, Robert A. Phillips^***, Stephen G. Rostand and Jackson T. Wright The African American Study of Kidney Disease and Hypertension Collaborative Research Group

*Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, Maryland; University of Texas Southwestern Medical Center at Dallas, Division of Nephrology, Department of Internal Medicine, Dallas, Texas; Nephrology Division, Department of Medicine, Mount Sinai School of Medicine, and ***Lenox Hill Hospital, New York University School of Medicine, New York City, New York; Department of Department of Internal Medicine, Charles R. Drew University, Los Angeles, California; ^¶National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland; **Department of Preventive Medicine, Rush Presbyterian-St. Luke’s Medical Center, Chicago, Illinois; Division of Hypertension, Department of Medicine, Case Western Reserve University School of Medicine, Cleveland; Department of Biostatistics and Epidemiology, Cleveland Clinic Foundation, Cleveland, Ohio; Department of Medicine, University of Michigan Health Systems, Ann Arbor, Michigan; ^¶¶Division of Nephrology, Department of Medicine, Vanderbilt University, Nashville, Tennessee; Division of Nephrology, University of Alabama, Birmingham, Alabama.

Correspondence to Dr. Lawrence J. Appel, Professor of Medicine, Epidemiology, and International Health (Human Nutrition), Johns Hopkins Medical Institutions, 2024 East Monument Street, Suite 2-645, Baltimore, MD 21205-2223. Phone: 410-955-4156; Fax: 410-955-0476;

ABSTRACT. Hypertensive kidney disease commonly progresses. The primary objective of the AASK (African American Study of Kidney Disease and Hypertension) Cohort Study is to determine prospectively the course of kidney function and risk factors for kidney disease progression in African Americans with hypertensive kidney disease who receive recommended anti-hypertensive therapy. The AASK Cohort Study is a prospective, observational study that is an extension of the AASK trial. The AASK trial tested the effects of three medications used as initial anti-hypertensive therapy (ramipril, metoprolol, and amlodipine) and two levels of BP control. Of the 1094 trial participants, approximately 650 to 700 individuals who have not reached ESRD will likely enroll in the Cohort Study. Risk factors to be studied include environmental, genetic, physiologic, and socioeconomic variables. The primary renal outcome is a composite clinical outcome defined by doubling of serum creatinine, ESRD, or death. Medication treatment for hypertension, beginning with the angiotensin converting enzyme inhibitor ramipril, is offered to all participants. In this fashion, the study directly controls two of the major determinants of kidney disease progression: treatment of hypertension and use of renoprotective, anti-hypertensive medication. The minimum duration of follow-up in the Cohort Study is 5 yr (total of 9 to 12 yr, including the period of the AASK trial). Ultimately, data from the AASK Cohort Study should enhance our understanding of the risk factors and processes that determine the progression of kidney disease. Such results might eventually lead to new strategies that delay or prevent ESRD. E-mail: lappel@jhmi.edu

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