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WFU will have big role over U.S. study
Med school will coordinate NIH blood-pressure groups
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Published: November 1, 2009
A nine-year national study measuring the effects of lowering blood-pressure levels will have a decided local influence.
Wake Forest University School of Medicine was named last week as the coordinating center for the $114 million study by the National Institutes of Health. The medical school also will serve as a clinical center for the Southeast, which includes the use of about 1,000 local participants.
Altogether, Wake will receive $49.3 million, or 43 percent, of the project's funding.
Beginning next fall, the Systolic Blood Pressure Intervention Trial will be conducted in more than 80 clinical sites involving 7,500 participates ages 55 and older.
The goal of the study is determining whether maintaining blood pressure at levels lower than current recommendations can further reduce the risk of cardiovascular and kidney diseases, or age-related cognitive decline.
"Nearly one out of every three Americans is affected by high blood pressure," said David Reboussin, a professor of biostatistical sciences in the Division of Public Health Sciences at WFU's medical school.
Reboussin is serving as the principal investigator for the coordinating center. Dr. David Goff, a professor of epidemiology in the medical school, will serve as the principal investigator for the Southeastern clinical network.
"The questions we seek to answer have a very big impact on the general population, especially here in the Southeast where hypertension is abundant," Reboussin said.
For example, stroke strikes about 750,000 people each year in the United States, leaving thousands disabled. People living in what is called the stroke belt, including North Carolina, South Carolina and Georgia, have higher incidence and mortality rates from stroke.
"This award to be the study's coordinating center is a great recognition of the success we at Wake Forest have had in the past in conducting large, impactful clinical trials," Reboussin said. "This grant gives a big boost to the research dollars at our institution."
Current clinical guidelines recommend systolic pressure -- the top number in a blood-pressure reading -- of less than 140 millimeters of mercury, or mm Hg. for healthy adults and 130 mm Hg for adults with kidney disease or diabetes.
The study 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 also will assess the potential risks of the strategy.
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.
Participants will be treated with available blood-pressure medications to reduce their blood-pressure reading to below 140 mm Hg in the standard group and below 120 mm Hg for the treatment group. Those in the treatment group will take an average of three to four medications, and those in the standard group will take about two medications.
Dr. Elizabeth Nabel, the director of the National Heart, Lung and Blood Institute, said that a long study is necessary to produce solid research on whether it is prudent to recommend lower blood-pressure guidelines.
"If this study shows that maintaining a lower systolic blood pressure has significant benefits for middle-aged and older adults ... we could see hundreds of thousands fewer heart attacks and stroke each year in the United States alone," Nabel said.
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