Systolic Blood Pressure Intervention Trial Primary Outcome Paper (SPRINT-POP) Data
Open BioLINCC Study See bottom of this webpage for request information
October 2010 – June 2016
August 22, 2016
Clinical Trial URLs
Primary Publication URLs
http://www.nejm.org/doi/full/10.... (N Engl J Med 2015; 373:2103-2116)
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
The Systolic Blood Pressure Trial (SPRINT) was conducted to test the hypothesis that treating systolic blood pressure to a goal lower than what is currently recommended would reduce the incidence of cardiovascular disease.
Hypertension is a highly prevalent condition among adults and is a leading risk factor for myocardial infarction and stroke. Further, isolated systolic hypertension is the most common form of hypertension in adults over 50 years of age. Observational studies have shown a monotonic increase in cardiovascular risk with systolic blood pressures above 115 mm Hg; however, general population clinical trials have only documented the benefits of lowering systolic blood pressure to a target of 150 mm Hg. A 2007 expert panel sponsored by the National Heart, Lung, and Blood Institute designated the hypothesis that lowering the systolic blood pressure goal to a level <120 mm Hg as the most important hypothesis to test in reducing hypertension related complications in those without diabetes.
Adults 50 years of age or more with a systolic blood pressure of 130 to 180 mm Hg with an increased risk of cardiovascular disease but without diabetes or a history of stroke. Increased cardiovascular risk was defined by one or more of the following: clinical or subclinical cardiovascular disease other than stroke; chronic kidney disease, excluding polycystic kidney disease, with an estimated glomerular filtration rate (eGFR) of 20 to less than 60 ml per minute per 1.73 m2 of body surface area as calculated by the four variable Modification of Diet in Renal Disease equation; a 10-year risk of cardiovascular disease of 15% or greater on the basis of the Framingham risk score; or an age of 75 years or older.
SPRINT was a randomized, single blinded (outcome adjudicators were blinded to treatment assignment) treatment trial with participants randomized to a systolic blood-pressure target of either less than 140 mm Hg (the standard-treatment group) or less than 120 mm Hg (the intensive-treatment group). The primary outcome was a composite outcome of myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes. A total of 9361 participants were randomized.
The intervention was stopped in August of 2015 (median follow-up of 3.26 years) after the cardiovascular outcome results exceeded the boundary for efficacy at two consecutive time points. Compared with a systolic blood pressure target of less than 140 mm Hg, an intensive systolic blood pressure target of 120 mm Hg resulted in lower rates of fatal and nonfatal major cardiovascular events and death from any cause. Significantly higher rates of some adverse events were observed in the intensive-treatment group.
N Engl J Med 2015; 373:2103-2116 DOI: 10.1056/NEJMoa1511939
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Resources AvailableStudy Datasets Only
- Data Dictionary (PDF - 76.2 KB)
- Code Book (XLSX - 31.1 KB)
- Protocol (PDF - 5.1 MB)
- README FRS Calculation Error (DOCX - 14.9 KB)
- README MonitoredLabs OrthostaticHypo Safety (DOCX - 12.9 KB)
- Reference Materials (PDF - 577.3 KB)
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