# Systolic Blood Pressure Intervention Trial (SPRINT) Study · id `cardio:sprint` · Cardiovascular Atlas · release `2b2017b84496b985` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Also called: SPRINT Browse, organ or system: Blood vessels Browse, condition area: High blood pressure ## In plain language A large US trial that compared aiming for a top blood-pressure number below 120 with aiming below 140 in adults aged 50 and over at higher heart risk who did not have diabetes or a past stroke. ## Technical summary NHLBI-sponsored, open-label randomized trial (NCT01206062) of 9361 adults comparing systolic targets below 120 and below 140 mm Hg. The composite cardiovascular primary outcome was adjudicated blind to assignment. The blood-pressure intervention was stopped early for benefit in 2015. Azilsartan and azilsartan with chlorthalidone were donated by Takeda and Arbor; the paper says neither company had any other role. ## Key facts - Design: Randomized, parallel-group, open-label trial with blinded outcome adjudication at 102 clinical sites in 5 clinical-center networks in the United States including Puerto Rico. The registry records allocation as randomized and masking as single (outcomes assessor). - Phase: Not applicable - Enrolled: 9361 participants (randomized count; A Randomized Trial of Intensive versus Standard Blood-Pressure Control, snapshot `cardio:pubmed-26551272-2026-10-09`, retrieved 2026-10-09) - Started: 2010-10 (actual) (Systolic Blood Pressure Intervention Trial (SPRINT), snapshot `cardio:ctgov-nct01206062-2026-10-09`, retrieved 2026-10-09) - Primary completion: 2016-07 (actual) (Systolic Blood Pressure Intervention Trial (SPRINT), snapshot `cardio:ctgov-nct01206062-2026-10-09`, retrieved 2026-10-09) - Completion: 2019-03 (actual) (Systolic Blood Pressure Intervention Trial (SPRINT), snapshot `cardio:ctgov-nct01206062-2026-10-09`, retrieved 2026-10-09) - Countries: United States (Systolic Blood Pressure Intervention Trial (SPRINT), snapshot `cardio:ctgov-nct01206062-2026-10-09`, retrieved 2026-10-09) - Care setting: Outpatient trial clinics at 102 clinical sites in 5 clinical-center networks in the United States, including Puerto Rico. Nursing-home and assisted-living residents were not enrolled. (A Randomized Trial of Intensive versus Standard Blood-Pressure Control, snapshot `cardio:pmc-pmc4689591-2026-10-09`, retrieved 2026-10-09) - Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `cardio:ctgov-nct01206062-2026-10-09`, retrieved 2026-10-09) - Stopped early: The intervention stopped early, 2015-08-20. The NHLBI director accepted the data and safety monitoring board recommendation, made after analyses of the primary outcome crossed the monitoring boundary at two consecutive time points. The registry records the trial itself as completed. (A Randomized Trial of Intensive versus Standard Blood-Pressure Control, snapshot `cardio:pmc-pmc4689591-2026-10-09`, retrieved 2026-10-09) ## Claims, with the population each applies to ## Context: Adults 50 and over with raised systolic blood pressure and increased cardiovascular risk, without diabetes or prior stroke (SPRINT) Recipient: Adult; Population: Adults aged 50 years or older with systolic blood pressure of 130 to 180 mm Hg (the registry lowers the upper limit as the number of blood-pressure medicines rises) and at least one increased-risk criterion, excluding diabetes mellitus and prior stroke.; Care setting: Outpatient trial clinics at 102 clinical sites. Nursing-home and assisted-living residents were not enrolled.; Geography: United States, including Puerto Rico; Life stage: Adult, 50 years and over (28.2% of each arm aged 75 or over, per Table 1 of the paper); Follow-up: Median follow-up 3.26 years when the blood-pressure intervention was stopped early on 2015-08-20. The registry gives a planned maximum follow-up of 6 years. Mean systolic pressure at 1 year was 121.4 mm Hg (intensive) and 136.2 mm Hg (standard). ### SPRINT's blood-pressure intervention was stopped early. On 20 August 2015 the NHLBI director accepted the data and safety monitoring board's recommendation, after analyses of the primary outcome crossed the monitoring boundary at two time points in a row. Median follow-up by then was 3.26 years, against a planned average of 5 years. - Category: Description - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: Recipient: Adult; Population: Adults aged 50 years or older with systolic blood pressure of 130 to 180 mm Hg (the registry lowers the upper limit as the number of blood-pressure medicines rises) and at least one increased-risk criterion, excluding diabetes mellitus and prior stroke.; Care setting: Outpatient trial clinics at 102 clinical sites. Nursing-home and assisted-living residents were not enrolled.; Geography: United States, including Puerto Rico; Life stage: Adult, 50 years and over (28.2% of each arm aged 75 or over, per Table 1 of the paper); Follow-up: Median follow-up 3.26 years when the blood-pressure intervention was stopped early on 2015-08-20. The registry gives a planned maximum follow-up of 6 years. Mean systolic pressure at 1 year was 121.4 mm Hg (intensive) and 136.2 mm Hg (standard). - Limitations: The registry gives a planned maximum follow-up of 6 years, while the paper gives a planned average of 5 years. These are different measures and are not reconciled. - Last checked: Not recorded - Source problem: a cited source is corrected. Check the sources before relying on this claim. - Sources: 1. Supports: A Randomized Trial of Intensive versus Standard Blood-Pressure Control (Publication, edition Version of record not fetched (HTTP 403). The abstract comes from PubMed (electronic article date 2015-11-09). Full-text facts come from the PMC author manuscript PMC4689591, which PMC marks as not the version of record.) Locator: Abstract, RESULTS, sentence 2: "The intervention was stopped early after a median follow-up of 3.26 years owing to a significantly lower rate of the primary composite outcome". Retrieved 2026-10-09T15:56:27Z. Source state: Corrected. Snapshot hash: 0469472c893c84018c2444c15e0a5337926968dadfdd96ad3771f84a69c4e40c. How it applies: Abstract of the primary report, for the same population and follow-up as this context. 2. Supports: A Randomized Trial of Intensive versus Standard Blood-Pressure Control (Publication, edition Version of record not fetched (HTTP 403). The abstract comes from PubMed (electronic article date 2015-11-09). Full-text facts come from the PMC author manuscript PMC4689591, which PMC marks as not the version of record.) Locator: Results, Study participants, para 1: "On August 20, 2015, the NHLBI director accepted a recommendation from the data and safety monitoring board". Retrieved 2026-10-09T15:57:07Z. Source state: Corrected. Snapshot hash: 14488a091a5a65b94db2789887ceff8e32d3c89d79db5656553e4429adf44be6. How it applies: PMC author manuscript, not the version of record. 3. Supports: A Randomized Trial of Intensive versus Standard Blood-Pressure Control (Publication, edition Version of record not fetched (HTTP 403). The abstract comes from PubMed (electronic article date 2015-11-09). Full-text facts come from the PMC author manuscript PMC4689591, which PMC marks as not the version of record.) Locator: Results, Study participants, para 1: "after analyses of the primary outcome exceeded the monitoring boundary at two consecutive time points". Retrieved 2026-10-09T15:57:07Z. Source state: Corrected. Snapshot hash: 14488a091a5a65b94db2789887ceff8e32d3c89d79db5656553e4429adf44be6. How it applies: PMC author manuscript, not the version of record. ## Study findings Findings are grouped by the claim they support. Each group keeps its own population and follow-up, and each finding keeps its own denominator and time window. Not reported is not zero. ### In SPRINT, adults aged 50 and over at raised heart risk, without diabetes or a past stroke, whose treatment aimed for a top (systolic) blood pressure below 120 mm Hg had fewer major heart and blood-vessel events than those aiming for below 140. Over a median of 3.26 years, 243 of 4678 people in the lower-target group and 319 of 4683 in the standard group had a first primary-outcome event (hazard ratio 0.75, 95% CI 0.64 to 0.89). Claim `cardio:claim-sprint-primary-effect`. Source problem: a cited source is corrected. Check the sources before relying on this claim. Applies to: Recipient: Adult; Population: Adults aged 50 years or older with systolic blood pressure of 130 to 180 mm Hg (the registry lowers the upper limit as the number of blood-pressure medicines rises) and at least one increased-risk criterion, excluding diabetes mellitus and prior stroke.; Care setting: Outpatient trial clinics at 102 clinical sites. Nursing-home and assisted-living residents were not enrolled.; Geography: United States, including Puerto Rico; Life stage: Adult, 50 years and over (28.2% of each arm aged 75 or over, per Table 1 of the paper); Follow-up: Median follow-up 3.26 years when the blood-pressure intervention was stopped early on 2015-08-20. The registry gives a planned maximum follow-up of 6 years. Mean systolic pressure at 1 year was 121.4 mm Hg (intensive) and 136.2 mm Hg (standard). Limitations: One open-label trial; outcome adjudicators did not know the assignment. The blood-pressure intervention was stopped early for benefit after crossing a monitoring boundary. The authors say the results do not generalize to people with diabetes, prior stroke or age under 50, or to nursing-home residents. The paper and the registry word the older-age entry criterion differently ("75 years or older" versus "greater than 75 years"), and this is not reconciled. The publication has a 2017 erratum whose content was not verified. Full-text figures come from the PMC author manuscript. - SPRINT primary composite cardiovascular outcome (Primary): Participants with at least one primary outcome event (count) 243 participants; reported as "243 (5.2%), 1.65% per year"; arm Intensive treatment, no comparator arm; interval Not applicable; denominator 4678 (All participants randomized to the arm (Table 2 "All participants" N, intention to treat). The registry outcome denominator is the same.); time window Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20 - SPRINT primary composite cardiovascular outcome (Primary): Participants with at least one primary outcome event (count) 319 participants; reported as "319 (6.8%), 2.19% per year"; arm Standard treatment, no comparator arm; interval Not applicable; denominator 4683 (All participants randomized to the arm (Table 2 "All participants" N, intention to treat). The registry outcome denominator is the same.); time window Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20 - SPRINT primary composite cardiovascular outcome (Primary): Hazard ratio, intensive vs standard (Cox proportional-hazards, stratified by clinic, intention to treat) 0.75 ratio; reported as "HR 0.75 (95% CI 0.64 to 0.89), P<0.001"; arm Intensive treatment compared with Standard treatment; interval 0.64 to 0.89 (two-sided 95% confidence interval); denominator Not applicable (basis: Comparison of the two per-arm rows (4678 vs 4683)); time window Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20 ### In the same trial and time window, fewer people in the lower-target group died from any cause: 155 of 4678 versus 210 of 4683 (hazard ratio 0.73, 95% CI 0.60 to 0.90). Claim `cardio:claim-sprint-mortality-effect`. Source problem: a cited source is corrected. Check the sources before relying on this claim. Applies to: Recipient: Adult; Population: Adults aged 50 years or older with systolic blood pressure of 130 to 180 mm Hg (the registry lowers the upper limit as the number of blood-pressure medicines rises) and at least one increased-risk criterion, excluding diabetes mellitus and prior stroke.; Care setting: Outpatient trial clinics at 102 clinical sites. Nursing-home and assisted-living residents were not enrolled.; Geography: United States, including Puerto Rico; Life stage: Adult, 50 years and over (28.2% of each arm aged 75 or over, per Table 1 of the paper); Follow-up: Median follow-up 3.26 years when the blood-pressure intervention was stopped early on 2015-08-20. The registry gives a planned maximum follow-up of 6 years. Mean systolic pressure at 1 year was 121.4 mm Hg (intensive) and 136.2 mm Hg (standard). Limitations: Secondary outcome. The limits of the primary-effect claim also apply: one open-label trial stopped early for benefit, results the authors do not extend to people with diabetes, prior stroke or age under 50, or to nursing-home residents, and a 2017 erratum whose content was not verified. - Death from any cause (Secondary): Participants who died (count) 155 participants; reported as "155 (3.3%), 1.03% per year"; arm Intensive treatment, no comparator arm; interval Not applicable; denominator 4678 (All participants randomized to the arm (Table 2 "All participants" N, intention to treat). The registry outcome denominator is the same.); time window Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20 - Death from any cause (Secondary): Participants who died (count) 210 participants; reported as "210 (4.5%), 1.40% per year"; arm Standard treatment, no comparator arm; interval Not applicable; denominator 4683 (All participants randomized to the arm (Table 2 "All participants" N, intention to treat). The registry outcome denominator is the same.); time window Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20 - Death from any cause (Secondary): Hazard ratio, intensive vs standard 0.73 ratio; reported as "HR 0.73 (95% CI 0.60 to 0.90), P=0.003"; arm Intensive treatment compared with Standard treatment; interval 0.6 to 0.9 (two-sided 95% confidence interval); denominator Not applicable (basis: Comparison of the two per-arm rows (4678 vs 4683)); time window Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20 ## Connected pages - Tests the intensive systolic target: Intensive systolic blood-pressure lowering (target below 120 mm Hg) (`cardio:intensive-sbp-lowering`) - Enrolled adults with raised systolic blood pressure: Hypertension (high blood pressure) (`core:hypertension`) - Lead sponsor: National Heart, Lung, and Blood Institute (`cardio:nhlbi`) - Co-sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (`cardio:niddk`) - Co-sponsor: National Institute of Neurological Disorders and Stroke (`cardio:ninds`) - Co-sponsor: National Institute on Aging (`cardio:nia`) - Funder named in the abstract: National Institutes of Health (`cardio:nih`) - Registry collaborator and coordinating-center affiliation: Wake Forest University Health Sciences (`cardio:wake-forest-health-sciences`) - Primary results, NEJM 2015: SPRINT primary results, NEJM 2015 (`cardio:pub-sprint-nejm-2015`) ## Provenance Content hash: 4327425bbaf725de122d6c16ee8c69ac89b169ec1ff707b798a2120b905d1142 Last substantive edit: 2026-10-09 Evidence last checked: Not recorded