The AASK is a multicenter, randomized, controlled clinical trial using a 2 × 3 factorial design to evaluate the effects of level of blood pressure control and type of anti-hypertensive medication on progression of chronic renal disease among African American men and women with chronic renal insufficiency caused by hypertension (hypertensive nephrosclerosis).
The AASK is a multicenter, randomized, controlled clinical trial using a 2 × 3 factorial design to evaluate the effects of level of blood pressure control and type of anti-hypertensive medication on progression of chronic renal disease among African American men and women with chronic renal insufficiency caused by hypertension (hypertensive nephrosclerosis). Two levels of blood pressure control were defined in terms of mean arterial pressure (MAP = 2/3 diastolic blood pressure + 1/3 systolic blood pressure). A usual goal is defined as an MAP of 102 to 107 mm Hg, and a low goal is defined as an MAP of 92 mm Hg or less. The three antihypertensive drug regimens contained either a calcium channel blocker (amlodipine), β-blocker (metoprolol; Toprol XL), or angiotensin-converting enzyme inhibitor (ramipril) as initial therapy. Progression of renal disease was measured as the rate of decline in glomerular filtration rate (GFR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,094
Lower Blood Pressure Goal (mean arterial pressure (MAP) less than or equal to 92 mm Hg) which corresponds to a BP of approximately 115/80 mmHg
Usual Blood Pressure Goal (mean arterial pressure (MAP) 102-107 mm Hg) which corresponds to a BP of approximately 135/85 to 140/90 mmHg
An angiotensin-converting enzyme inhibitor, (ACEI: ramipril) 2.5 to 10 mg/d
Rate of change in GFR
GFR slope was determined separately during the first 3 months after randomization (acute phase) and during the remainder of follow-up (chronic phase)
Time frame: Up to 3 years
Time to 50% reduction in GFR, ESRD, or death up to 3 years
Time from randomization to any of the following (1) confirmed reduction in GFR by 50% or by 25 mL/min per 1.73 m\^2, (2) end stage renal disease (ESRD), or (3) death
Time frame: Up to 3 years
Change in proteinuria
Change in proteinuria from baseline to the end of follow-up
Time frame: Baseline to 3 years
Time to 50% reduction in GFR, ESRD, or death up to 10 years
Time from randomization to any of the following (1) confirmed reduction in GFR by 50% or by 25 mL/min per 1.73 m\^2, (2) end stage renal disease (ESRD), or (3) death
Time frame: Up to 10 years
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A dihydropyridine calcium channel blocker, (DHPCCB: amlodipine) 5 to 10 mg/d
A sustained release beta-blocker, (BB: metoprolol) 50 to 200 mg/d