Design and baseline characteristics of participants in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study.
Hypertension and end-stage renal disease (ESRD) are major causes of morbidity and mortality in the United States, especially among African Americans. The African American Study of Kidney Disease and Hypertension (AASK) Pilot Study evaluated the feasibility of conducting a long-term clinical trial to compare the effects of two levels of blood pressure control and three different antihypertensive drug regimens on the rate of decline in glomerular filtration rate (GFR) in African Americans with clinically diagnosed hypertensive renal disease. African American men and women aged 18-70 years with a GFR of 25-70 ml/min/ 1.73m2 and hypertension were randomized in a 3 x 2 factorial design to initial treatment with either an angiotensin-converting enzyme inhibitor (enalapril), a calcium channel blocker (amlodipine), or a beta blocker (atenolol) and to a mean arterial blood pressure (goal MAP) of either 102-107 mm Hg or < or = 92 mm Hg. Furosemide, doxazosin, clonidine, hydralazine, and minoxidil were added sequentially until goal MAP was achieved. To compare the pathologic diagnosis with the clinical diagnosis of renal disease, study participants without contraindication were also asked to undergo a renal biopsy. The goals of the AASK Pilot Study were to evaluate recruitment techniques, adherence to prescribed antihypertensive drug regimens, ability of the antihypertensive regimens to achieve blood pressure goals, rates of participation in scheduled clinic visits and procedures, and variability of GFR measurements. A further goal was to obtain renal biopsy data in at least 75% of the randomized study participants. Compared to the ESRD patient population whose renal disease is caused by hypertension, women were underrepresented in the AASK Pilot Study. AASK Pilot Study participants had higher unemployment rates and lower income levels than African Americans in the general U.S. population.
NIDDK, NIH, Bethesda, MD 20892-6600, USA.
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D000328:Adult; D001741:Black or African American; D000368:Aged; D017311:Amlodipine / Q000494:pharmacology / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001262:Atenolol / Q000494:pharmacology / Q000627:therapeutic use; D001794:Blood Pressure; D004341:Drug Evaluation / Q000379:methods*; D004656:Enalapril / Q000494:pharmacology / Q000627:therapeutic use; D005260:Female; D006801:Humans; D006977:Hypertension, Renal / Q000188:drug therapy* / Q000473:pathology; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010349:Patient Compliance; D018579:Patient Selection; D010865:Pilot Projects; D011786:Quality Control; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D018401:Sample Size
D000959:Antihypertensive Agents; D017311:Amlodipine; D001262:Atenolol; D004656:Enalapril