Sixty-five African Americans aged 18-70 years with hypertensive kidney disease will be randomized to treatment for 4 years with either an angiotensin converting enzyme inhibitor, a calcium channel blocker or a beta-blocker as a first line antihypertensive drug, and to one of two levels of BP control to determine: 1) whether treatment of hypertension slows progression of renal insufficiency; 2) whether one of the three drugs offers a specific reno-protective effect; and 3) whether control of BP to a lower level protects renal function to a greater degree. BP will be monitored and medications adjusted at least monthly to monitor patient compliance and adverse effects and to ensure that assigned BP goals are achieved. Glomerular filtration rate will be measured quarterly as the plasma disappearance of [125I]-iothalamate. Subjects will be recruited from clinics at the Medical University of South Carolina (MUSC), Fetter Family Health Clinics, the SC Department of Health, private physicians, local churches, and community hypertension screening programs. The study will be publicized locally using television, radio, newspapers, posters, and letters to physicians. To encourage subject participation and to ensure retention and compliance, study visits will be performed at sites convenient to the target population in downtown Charleston, on Johns Island and on Yonges Island, using the clinic facilities of the Fetter Family Health Centers, as well as the General Clinical Research Center (GCRC) at MUSC. Transportation will be provided. A fulltime nurse coordinator and data clerk will coordinate scheduling of appointments and ensure followup of patients. An experienced pharmacist will assist with medication distribution, tracking, and documentation. Local clinical laboratory backup has been arranged through the GCRC laboratory, the MUSC Clinical Laboratory and the Fetter Clinic Laboratories. Data collection and management will be facilitated by the use of the GCRC Prophet computer resource which is networked to the NIH and to PCs used by the study personnel.
Gadegbeku, Crystal A; Stillman, Phyllis Kreger; Huffman, Mark D et al. (2008) Factors associated with enrollment of African Americans into a clinical trial: results from the African American study of kidney disease and hypertension. Contemp Clin Trials 29:837-42 |
Kusek, John W; Greene, Paul; Wang, Shin-Ru et al. (2002) Cross-sectional study of health-related quality of life in African Americans with chronic renal insufficiency: the African American Study of Kidney Disease and Hypertension Trial. Am J Kidney Dis 39:513-24 |