title: Design and statistical aspects of the African American Study of Kidney Disease and Hypertension (AASK).
abstract: The African American Study of Kidney Disease and Hypertension (AASK) is a multicenter randomized clinical trial designed to test the effectiveness of three anti-hypertensive drug regimens and two levels of BP control on the progression of hypertensive kidney disease. Participants include African-American men and women aged 18 to 70 yr who have hypertensive kidney disease and GFR between 20 and 65 ml/min per 1.73 m(2). The three anti-hypertensive drug regimens include an angiotensin converting enzyme inhibitor (ramipril), a dihydropyridine calcium channel blocker (amlodipine) or a beta-blocker (metoprolol) as initial therapy. The BP control levels are a lower goal (mean arterial pressure, </=92 mmHg) and a usual goal (mean arterial pressure, 102 to 107 mmHg inclusive). The primary outcome is rate of change in renal function as measured by GFR, assessed by (125) I-iothalamate clearance. The main secondary patient outcome is a composite including the following events: (1) reduction in GFR by 50%, (2) end-stage renal disease, or (3) death.
authors.affiliation: Cleveland Clinic Department of Biostatistics, Ohio, 44195, USA. jgassman@bio.ri.ccf.org
authors.forename: Jennifer J
authors.initials: JJ
authors.lastname: Gassman
authors.forename: Tom
authors.initials: T
authors.lastname: Greene
authors.forename: Jackson T
authors.initials: JT
authors.lastname: Wright
authors.forename: Lawrence
authors.initials: L
authors.lastname: Agodoa
authors.forename: George
authors.initials: G
authors.lastname: Bakris
authors.forename: Gerald J
authors.initials: GJ
authors.lastname: Beck
authors.forename: Janice
authors.initials: J
authors.lastname: Douglas
authors.forename: Ken
authors.initials: K
authors.lastname: Jamerson
authors.forename: Julia
authors.initials: J
authors.lastname: Lewis
authors.forename: Michael
authors.initials: M
authors.lastname: Kutner
authors.forename: Otelio S
authors.initials: OS
authors.lastname: Randall
authors.forename: Shin-Ru
authors.initials: SR
authors.lastname: Wang
mesh_terms: D000293:Adolescent; D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage; D000328:Adult; D001741:Black or African American / Q000706:statistics & numerical data*; D000368:Aged; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D002121:Calcium Channel Blockers / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000175:diagnosis* / Q000188:drug therapy*; D007676:Kidney Failure, Chronic / Q000150:complications / Q000175:diagnosis* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D018570:Risk Assessment; D016896:Treatment Outcome; D014481:United States
chemical_list: D000319:Adrenergic beta-Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers