At the Top Ten Clinical Research Achievement Awards ceremony in April, the Systolic Blood Pressure Intervention Trial (SPRINT) Study was awarded the Top Ten Clinical Research Achievement Award and the Herbert Pardes Award for Clinical Research Excellence. Winning papers were chosen based on their degree of innovation, representing the best and brightest work in the field, and the ability to lead to advancements in medicine that change lives and patient outcomes worldwide.
The SPRINT Study, a landmark clinical trial sponsored by the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH), was designed to answer the question “Will lower blood pressure reduce the risk of heart and kidney diseases, stroke, or age-related declines in memory and thinking?” More than 9,300 participants were recruited from about 100 medical centers and clinical practices throughout the United States and Puerto Rico. Two of those clinical centers are located here in Memphis: one at the University of Tennessee Health Science Center, headed by Karen C. Johnson, MD, MPH, and one at the VA Medical Center, headed by Barry Wall, MD. William Cushman, MD, headed the VA Clinical Center Network (CCN) for SPRINT that included 25 VA sites around the country. Dr. Johnson also served as the Vice Chair of the SPRINT National Steering Committee. Dr. Cushman, also a member of the Steering Committee, served as the Chair of the SPRINT National Intervention Committee.
About 1 in 3 people in the US has high blood pressure (BP), or hypertension, and it is the leading risk factor for heart disease, stroke, kidney failure, and other health problems. When SPRINT was created, clinical guidelines recommended treating systolic BP to less than 140 mm Hg for healthy adults and 130 mm Hg for adults with kidney disease or diabetes. The study is one of the largest of its kind to date to examine how maintaining systolic blood pressure at a lower than currently recommended level will impact cardiovascular and kidney diseases.
The SPRINT Study population included persons with hypertension who were 50 years and older who were at increased risk for heart disease. SPRINT enrolled women and men, racial/ethnic minorities, and the elderly. It did not, however, include patients with diabetes, prior stroke, or polycystic kidney disease, as other research included those populations. From 2010 to 2013, participants were separated into two groups that differed according to targeted levels of blood pressure control. The standard group received BP medications to achieve a target of less than 140 mm Hg. On average two different BP medications were needed to get to this goal. The intensive treatment group received medications to achieve a target of less than 120 mm Hg and an average of three medications were needed to get to this goal.
“We found that the intensive intervention reduces rates of cardiovascular events by 25% and mortality rates by 27% compared to the target systolic pressure of 140 mm Hg,” says Johnson (pictured left).
Due to the significance of the initial findings, NIH actually stopped the blood pressure intervention earlier than originally planned in order to let participants know this beneficial finding. Publication soon followed.
“The Study showed that maintaining a lower systolic pressure by this more intensive BP intervention could ultimately help save lives in older or high-risk patients who have a combination of high BP and at least one other risk factor for heart disease,” says Cushman (pictured right).
Drs. Johnson and Cushman say that while these findings are ground-breaking, patients should still consult their doctors to determine whether this lower goal is best for their individual treatment. They also add that no one site could have done this kind of study alone. It was truly a team effort; one that could not have been achieved without all the hard work and dedication of the research staff and commitment of the participants.
The SPRINT Study is also examining kidney disease, cognitive function, and dementia among the patients. Those results are still being collected and are not yet available. Primary results were published in the New England Journal of Medicine in November 2015. Additional papers from the Study will be published in the next few months.