Case Western Reserve University School of Medicine has received a $14.7 million, nine-year contract from the National Institutes of Health to be one of five institutions to lead a trial to determine if lowering systolic blood pressure in hypertensive patients, without diabetes, to below the currently recommended level can reduce the incidence of cardiovascular and kidney disease and slow cognitive decline. Case Western Reserve will head a Clinical Center Network (CCN) consisting of investigators from its School of Medicine and three other Northeast Ohio clinical centers, as well as The Ohio State University College of Medicine. It will be directed by Jackson T. Wright, Jr., M.D., Ph.D., Professor of Medicine, Case Western Reserve and Director of the Clinical Hypertension Program at University Hospitals Case Medical Center (UHCMC).
"The objective of the study is to evaluate whether treating patients to systolic blood pressure of less than 120 mmHg reduces the risk of cardiovascular and kidney disease, or age-related cognitive decline, more than the usually recommended level of less than 140 mmHg," says Dr. Wright. "We suspect that treating to the lower level of 120 mmHg will result in fewer cardiovascular and kidney complications. However, this needs to be proven."
The results of this study will grow the small body of evidence supporting this hypothesis. Called SPRINT (Systolic Blood Pressure Intervention Trial), the study findings will be used to reevaluate the optimal blood pressure for patients and have the potential to establish new guidelines for healthcare providers. SPRINT will enroll approximately 7,500 participants, age 55 or older, with systolic blood pressure of 130 mm Hg or higher. All participants will have a history of cardiovascular disease or be at high risk for heart disease by having at least one additional risk factor, except diabetes; between 40- and 50 percent will have chronic kidney disease. Blacks and other minorities will comprise at least 30 percent of the study. The Case Western Reserve CCN will recruit approximately 1,500 patients.
A very important sub-study of SPRINT will evaluate how the higher versus lower blood pressure goals affect cognition function and dementia. Alan Lerner, M.D., Professor of Neurology, and Director of the Memory and Cognition Center at UHCMC will lead the Case Western Reserve University efforts for this cognitive functioning sub-study, called SPRINT-MIND.
The Case Western Reserve CCN is a network consisting of the major academic medical centers in Northeast Ohio and The Ohio State University College of Medicine; the clinical centers and investigators in the CCN include:
SPRINT study investigators will make substantial use of the resources available through the Clinical and Translational Science Awards (CTSA) at each university: the Clinical & Translational Science Collaborative at Case Western Reserve University and The Ohio State University Center for Clinical and Translational Science. These CTSA grants are NIH-funded consortiums designed to transform how clinical and translational research is conducted, with the goal of enabling researchers to provide new treatments to patients more efficiently and quickly. Both CTSAs will assist in the recruitment of SPRINT study patients and the monitoring of participants.
"SPRINT is an important comparative effectiveness clinical trial," said Elizabeth G. Nabel, M.D., Director of the NIH's National Heart, Lung, and Blood Institute (NHLBI), the lead funder of the study. "The results will help patients and their doctors determine whether more aggressive blood pressure treatment is beneficial in reducing overall deaths, heart attacks, strokes, kidney failure, or age-related cognitive decline."
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) —are funding SPRINT-MIND.
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