Design and statistical aspects of the African American Study of Kidney Disease and Hypertension (AASK).
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.
Gassman
Jennifer J
JJ
Cleveland Clinic Department of Biostatistics, Ohio, 44195, USA. jgassman@bio.ri.ccf.org
Greene
Tom
T
Wright
Jackson T
JT
Agodoa
Lawrence
L
Bakris
George
G
Beck
Gerald J
GJ
Douglas
Janice
J
Jamerson
Ken
K
Lewis
Julia
J
Kutner
Michael
M
Randall
Otelio S
OS
Wang
Shin-Ru
SR
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
D000319:Adrenergic beta-Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers