Systolic Blood Pressure Intervention Trial (SPRINT) - Catalog
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Name
Systolic Blood Pressure Intervention Trial (SPRINT)
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Accession Number
HLB02021923b
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Acronym
SPRINT
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Related studies
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BSI Study IDs
SPT
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Is public use dataset
False
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Keywords
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Ingestion StatusReleased
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Has Study Datasets
True
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Has Specimens
True
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Specimen ID TypeCoded
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Study Website
https://www.sprinttrial.org/public/dspHome.cfm
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The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.
False
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Clinical Trial URLs
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Study typeClinical Trial
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Collection TypeOpen BioLINCC Study
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Cohort typeAdult
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Interventions
Drug: Intensive control of SBP
Drug: Standard control of SBP -
Study Open Date (Data)
2019-06-24
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Study Open Date (Specimens)
2019-06-24
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Date materials available
2019-06-24
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Last updated
2020-07-22
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Study period
October 2010 – July 2016
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Study Contacts
Alfred.Cheung@hsc.utah.edu - Data Renewal Request, Data Request
kille001@umn.edu - Data Renewal Request, Data Request
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NHLBI Division
DCVS
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ClassificationHeart
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HIV study classificationnon-HIV
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COVID study classificationnon-COVID
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Pre-Website # of Specimens Shipped
None
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# of Returned Specimens
None
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Primary Publication URLs
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Commercial use data restrictionsNo
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Data restrictions based on area of researchNo
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Commercial use specimen restrictionsNo
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Non-genetic use specimen restrictions based on area of useYes
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Genetic use of specimens allowed?Yes, For Some Specimens
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Genetic use area of research restrictionsYes
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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.
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ConditionsHypertension
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Objectives
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.
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Background
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.
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Participants
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.
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Design
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.
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Conclusions
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
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Disease classification
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Publications
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Mat typesDNA
Plasma
Serum
Urine
Urine Pellet/Sediment
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Network
The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.
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Subjects
Intensive-treatment group: 4,678 subjects
Standard-treatment group: 4,683 subjects
Last Modified: June 16, 2025, 4:52 p.m. -
Age
Intensive
Standard
Total Subjects
45-50
47
66
113
51-55
375
393
768
56-60
727
707
1,434
61-65
954
959
1,913
66-70
714
706
1,420
71-75
705
675
1,380
76-80
674
705
1,379
80+
482
472
954
Last Modified: June 16, 2025, 4:52 p.m. -
Sex
Intensive
Standard
Total Subjects
Male
2,994
3,035
6,029
Female
1,684
1,648
3,332
Last Modified: June 16, 2025, 4:52 p.m. -
Race
Intensive
Standard
Total Subjects
White
3,037
3,034
6,071
Black
1,444
1,481
2,925
American Indian/Alaska Native
*S
*S
14
Native Hawaiian/Pacific Islander
*S
*S
11
Asian
45
31
76
Other
115
101
216
Mixed
22
24
46
Unknown/Missing
1
1
2
*Values have been suppressed due to low counts
Last Modified: June 16, 2025, 4:52 p.m.
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 3.0 of the BioLINCC Handbook describes the components of the review process.
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Material Types
Serum, Plasma, DNA, Liquid Urine, Urine Pellets
Last Modified: June 16, 2025, 4:52 p.m. -
General Freeze/Thaw Status
As of 06/16/2023, 90% 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.
Last Modified: June 16, 2025, 4:52 p.m. -
Visits (Vials)
06/16/2025
Serum
Plasma
DNA
Urine
Urine - Pellets
Total Vials
Randomization
39,892
50,425
42,000
29,646
8,661
170,624
Year 1
38,140
45,481
.
30,191
7,838
121,650
Year 2
36,497
44,093
.
30,485
7,570
118,645
Year 4
11,383
15,192
.
9,478
2,471
38,524
Close Out
20,400
26,969
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17,988
4,516
69,873
Last Modified: June 16, 2025, 4:52 p.m. -
Visits (Subjects)
06/16/2025
Serum
Total number of subjects
Average volume (mL) per subject
Randomization
8,792
2.34
Year 1
8,058
2.53
Year 2
7,702
2.50
Year 4
2,569
2.43
Close Out
4,550
2.46
Plasma
Total number of subjects
Average volume (mL) per subject
Randomization
8,756
2.54
Year 1
8,028
2.72
Year 2
7,701
2.80
Year 4
2,572
3.08
Close Out
4,552
3.01
DNA
Total number of subjects
Average mass (ug) per subject
Randomization
8,459
163.05
Urine
Total number of subjects
Average volume (mL) per subject
Randomization
8,770
5.04
Year 1
7,972
5.57
Year 2
7,688
5.92
Year 4
2,558
5.39
Close Out
4,536
5.89
Urine - Pellets
Total number of subjects
Average vials per subject
Randomization
8,629
1.00
Year 1
7,800
1.00
Year 2
7,537
1.00
Year 4
2,114
1.17
Close Out
4,511
1.00
Last Modified: June 16, 2025, 4:52 p.m.