Design and statistical aspects of the African American Study of Kidney Disease and Hypertension (AASK)

J Am Soc Nephrol. 2003 Jul;14(7 Suppl 2):S154-65. doi: 10.1097/01.asn.0000070080.21680.cb.

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adrenergic beta-Antagonists / administration & dosage
  • Adult
  • Aged
  • Angiotensin-Converting Enzyme Inhibitors / administration & dosage
  • Antihypertensive Agents / administration & dosage*
  • Black or African American / statistics & numerical data*
  • Calcium Channel Blockers / administration & dosage
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Humans
  • Hypertension / complications
  • Hypertension / diagnosis*
  • Hypertension / drug therapy*
  • Kidney Failure, Chronic / complications
  • Kidney Failure, Chronic / diagnosis*
  • Kidney Failure, Chronic / therapy
  • Male
  • Middle Aged
  • Pilot Projects
  • Risk Assessment
  • Treatment Outcome
  • United States

Substances

  • Adrenergic beta-Antagonists
  • Angiotensin-Converting Enzyme Inhibitors
  • Antihypertensive Agents
  • Calcium Channel Blockers