AFRICAN AMERICAN STUDY OF KIDNEY DISEASE & HYPERTENSION

本文件涉及纽约市一个拟议的临床中心。

This submission deals with a proposed clinical center in New York City. The target population will be 100% Black and at least 30% female or male. The full-scale trial is a multi-center, prospective, double-blinded, randomized study examining the effect of three antihypertensive drug regimens each with different initial randomized drugs and treatment to two different levels of blood pressure (BP) on the preservation of renal function determined by glomerular filtration rate (GFR) in African Americans with hypertension and reduced renal function. The study will have a three by two factorial design. There will be three drug regimens with differing first line drugs, (calcium channel blocker, an angiotensin converting enzyme inhibitor, and a beta-blocker) and there will be two levels of goal BP as defined by the mean arterial pressure (MAP). These goals will be MAP equal to or less than 92 mm Hg for one group and a MAP between 102-107 mmHg for the other. The proposed study will be conducted in fourteen clinical centers and one coordinating center over 84 months. The plan is to randomize at least 65 study participants at the N.Y. Center from three sources. We can easily increase this to 100 participants if needed. We expect to recruit 20-25 patients from each source. It is understood that the study will be conducted in three phases: 1. Participant Recruitment: 24 months; 2. Intervention and Follow-up: 48 months; 3. Study Close-Out and Data Analysis: 12 months. The antihypertensive therapy will be begun immediately post-randomization. Follow-up procedures, including measurement of blood pressure and GFR, will be carried out during a follow-up period of 48 months. A 12-month period will be used for close-out of Clinical Centers, data analysis, and reporting of results. All data will be submitted centrally and access to data and publications will be by the mechanism(s) defined in the protocol. Iothalamate clearances will be analyzed centrally. A modified physical exam by the clinic M.D. as well as complete blood chemistries, urine analysis including an early morning urine for sediment, ECG, and measurement of GFR, quality of life questionnaire, and general medical history will be obtained. The study will resolve questions of how to prevent or delay end stage renal disease related to hypertension in African Americans.