U of U Is One of Five Network Centers in NIH Clinical Trial to Test Blood Pressure Strategy
The University of Utah is one of five centers chosen to lead a $114 million National Institutes of Health randomized clinical trial to determine whether maintaining blood pressure levels lower than current recommendations further reduces the risk of cardiovascular and kidney diseases or age-related cognitive decline.
Oct 29, 2009 4:47 PMSALT LAKE CITY—The University of Utah is one of five centers chosen to lead a $114 million National Institutes of Health randomized clinical trial to determine whether maintaining blood pressure levels lower than current recommendations further reduces the risk of cardiovascular and kidney diseases or age-related cognitive decline.
Called the Systolic Blood Pressure Intervention Trial (SPRINT), the nine-year study will be conducted in more than 80 clinical sites across the United States. The principal investigator for the Utah site is Alfred K. Cheung, M.D., a kidney specialist and professor of internal medicine at the U of U School of Medicine. Intermountain Health Care also is participating as a clinical center under the direction of the University.
Wake Forest University, Winston-Salem, N.C., is the national coordinating center.
High blood pressure is one of the most common conditions among middle-aged and older adults, and is a leading risk factor for stroke, heart disease, kidney failure, and other conditions. High blood pressure is also a key contributor to the development and progression of chronic kidney disease. Nearly one in three adult Americans has high blood pressure, and worldwide estimates suggest that more than 900 million adults have high blood pressure.
Current clinical guidelines recommend systolic pressure (the top number in a blood pressure reading, which measures pressure when the heart is pumping blood) of less than 140 millimeters of mercury (mm Hg) for healthy adults, and 130 mm Hg for adults with kidney disease or diabetes. SPRINT will evaluate the potential benefits of maintaining systolic blood pressure at less than 120 mm Hg for adults who are at risk for heart disease or kidney disease. The study will also assess possible risks of this therapeutic strategy.
Study participants will be treated with commonly available blood pressure medications to achieve one of two different levels of blood pressure control – either less than 140 mm Hg (standard group) or less than 120 mm Hg (treatment group). Those in the treatment group will take an average of three to four medications; those in the standard group will take about two medications. SPRINT participants will be seen in clinics every few months at the beginning of the study and less frequently as their blood pressure is controlled. The study will include standard tests for determining the health of the heart, kidneys, and brain.
SPRINT will enroll approximately 7,500 participants nationwide, age 55 or older, with systolic blood pressure of 130 mm Hg or higher. Participants will have a history of cardiovascular disease; be at high risk for heart disease by having at least one additional risk factor, such as smoking or high blood cholesterol levels; or have chronic kidney disease. Patients with a history of stroke or diabetes are not expected to be studied in SPRINT because other randomized clinical trials are currently testing similar strategies in these patients.
Enrollment for SPRINT is expected to begin in fall 2010. Participants will be randomly assigned to one of two groups: to treat systolic blood pressure to the lower goal of less than 120 mm Hg or to treat to the standard goal of less than 140 mm Hg. Participants will be followed for at least four years. Researchers will then compare the two groups to see if the participants in the lower blood pressure group had fewer heart attacks or strokes; were less likely to develop heart failure or chronic kidney disease; or had less decline in cognitive function. Deaths due to cardiovascular disease and quality-of-life measures will also be studied. In addition, a subgroup of participants will have moderate, or stage 3, kidney disease at enrollment; they will be studied to determine the impact of lower blood pressure on their risk of cardiovascular disease as well as end-stage kidney disease.
SPRINT is funded by the NHLBI and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Two other NIH institutes – the National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute on Aging (NIA) – will support SPRINT-MIND, a substudy that focuses on the impact of lowering systolic blood pressure to reduce cognitive impairment, an important early indication of dementia.
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