Systolic Blood Pressure Intervention Trial (SPRINT)
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Open BioLINCC Study See bottom of this webpage for request information
October 2010 – July 2016
June 24, 2019
July 22, 2020
Clinical Trial URLs
Primary Publication URLs
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Commercial Use Specimen Restrictions No
Non-Genetic Use Specimen Restrictions Based On Area Of Use Yes
Genetic Use Of Specimens Allowed? Yes, For Some Specimens
Genetic Use Area Of Research Restrictions Yes
Specific Consent Restrictions
Use of biospecimens in non-genetic or genetic research is tiered to (1) research related to hypertension, heart and vascular disease, kidney disease, memory and brain disorders, and their risk factors, or (2) research for any major disease, health condition or risk factors.
The available data include all elements of the previously released SPRINT Primary Outcome Paper (SPRINT-POP) data, the full SPRINT clinical data including the MRI and MIND data, and select ancillary study data (Ambulatory Blood Pressure Monitoring, APOL1, Acute Kidney Injury).
The Systolic Blood Pressure Trial (SPRINT) was conducted to test the hypothesis that treating systolic blood pressure to a target of less than 120 mm Hg, as compared to a target of less than 140 mm Hg, 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.
Eligible participants were 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. A total of 9361 participants were enrolled, with 4,678 randomized to the intensive-treatment group and 4,683 randomized to the standard-treatment group.
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). Following randomization, baseline hypertensive regimens were adjusted in accordance with study treatment algorithms established for each group. The study formulary included all major classes of antihypertensive agents. Investigators could prescribe other antihypertensive medications, but the use of drug classes with the strongest evidence for reduction in cardiovascular outcomes was encouraged. This included thiazide-type diuretics as the first-line agent, loop diuretics for participants with advanced chronic kidney disease, and beta-adrenergic blockers for participants with coronary artery disease. Medications for participants in the intensive-treatment group were adjusted on a monthly basis to target a systolic blood pressure of less than 120 mm Hg. Medications for participants in the standard-treatment group were adjusted to target a systolic blood pressure of 135 to 139 mm Hg, and the dose was reduced if systolic blood pressure was less than 130 mm Hg on a single visit or less than 135 mm Hg on two consecutive visits. Lifestyle modification was encouraged as part of the management strategy.
Participants were seen monthly for the first 3 months and every 3 months thereafter. Demographic data were collected at baseline. Clinical and laboratory data were obtained at baseline and every 3 months thereafter. A structured interview was used in both groups every 3 months to obtain self-reported cardiovascular disease outcomes. Medical records and electrocardiograms were obtained for documentation of events. Incidences of hypotension, syncope, injurious falls, electrolyte abnormalities, and bradycardia that were evaluated in an emergency department were included in adverse event reporting. Occurrences of acute kidney injury or acute renal failure requiring hospitalization were also monitored.
The primary outcome was a composite outcome of myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes.
The blood pressure 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
Intensive-treatment group: 4,677 subjects
Standard-treatment group: 4,682 subjects
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Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process
As of 06/15/2020, 95% of vials have never been thawed. Most of the remaining vials have undergone one freeze-thaw cycle, with a very small number of serum vials having 2.
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Resources AvailableSpecimens and Study Datasets
- Urine Pellet/Sediment
- More Details
- Data Dictionary (PDF - 2.6 MB)
- Ancillary Studies Data Dictionary (PDF - 612.5 KB)
- SPRINT Forms (PDF - 973.8 KB)
- SPRINT Guide to Use of Data Sets (PDF - 173.3 KB)
- SPRINT Manual of Procedures (PDF - 9.2 MB)
- SPRINT Protocol (PDF - 2.1 MB)
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