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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK048689-05
Application #
2734192
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Project Start
1994-08-19
Project End
2001-06-30
Budget Start
1998-09-25
Budget End
1999-06-30
Support Year
5
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Mount Sinai School of Medicine
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
114400633
City
New York
State
NY
Country
United States
Zip Code
10029
Chen, Teresa K; Appel, Lawrence J; Grams, Morgan E et al. (2017) APOL1 Risk Variants and Cardiovascular Disease: Results From the AASK (African American Study of Kidney Disease and Hypertension). Arterioscler Thromb Vasc Biol 37:1765-1769
Ku, Elaine; Gassman, Jennifer; Appel, Lawrence J et al. (2017) BP Control and Long-Term Risk of ESRD and Mortality. J Am Soc Nephrol 28:671-677
Chen, Teresa K; Tin, Adrienne; Peralta, Carmen A et al. (2017) APOL1 Risk Variants, Incident Proteinuria, and Subsequent eGFR Decline in Blacks with Hypertension-Attributed CKD. Clin J Am Soc Nephrol 12:1771-1777
Chen, Teresa K; Choi, Michael J; Kao, W H Linda et al. (2015) Examination of Potential Modifiers of the Association of APOL1 Alleles with CKD Progression. Clin J Am Soc Nephrol 10:2128-35
Anthony, Ericha G; Richard, Erin; Lipkowitz, Michael S et al. (2015) Association of the ADRB2 (rs2053044) polymorphism and angiotensin-converting enzyme-inhibitor blood pressure response in the African American Study of Kidney Disease and Hypertension. Pharmacogenet Genomics 25:444-9
Lipkowitz, Michael S; Freedman, Barry I; Langefeld, Carl D et al. (2013) Apolipoprotein L1 gene variants associate with hypertension-attributed nephropathy and the rate of kidney function decline in African Americans. Kidney Int 83:114-20
Fung, Maple M; Salem, Rany M; Lipkowitz, Michael S et al. (2012) Methylenetetrahydrofolate reductase (MTHFR) polymorphism A1298C (Glu429Ala) predicts decline in renal function over time in the African-American Study of Kidney Disease and Hypertension (AASK) Trial and Veterans Affairs Hypertension Cohort (VAHC). Nephrol Dial Transplant 27:197-205
Norman, Silas P; Kommareddi, Mallika; Ojo, Akinlolu O et al. (2011) Early pancreas graft failure is associated with inferior late clinical outcomes after simultaneous kidney-pancreas transplantation. Transplantation 92:796-801
Lee, Jason; Aziz, Hossein; Liu, Lin et al. (2011) ?(1)-adrenergic receptor polymorphisms and response to ?-blockade in the African-American study of kidney disease and hypertension (AASK). Am J Hypertens 24:694-700
Bhatnagar, Vibha; Garcia, Erin P; O'Connor, Daniel T et al. (2010) CYP3A4 and CYP3A5 polymorphisms and blood pressure response to amlodipine among African-American men and women with early hypertensive renal disease. Am J Nephrol 31:95-103

Showing the most recent 10 out of 17 publications