Systolic Blood Pressure Intervention Trial (SPRINT)
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.
Also called SPRINT
- Study
- In this atlas
Overview
- 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
- 9,361 participants
- Sponsor
- Registry
-
NCT01206062
-
- Results reported in
- Started
- (actual)
- Primary completion
- (actual)
- Completion
- (actual)
- Countries
- United States
- 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.
- Registry status
- “COMPLETED”
- Stopped early
- The intervention stopped early, . 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.
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.
Arms
-
Intensive treatment
Intervention Intensive systolic blood-pressure lowering (target below 120 mm Hg)
Systolic target below 120 mm Hg, with medicines adjusted monthly toward the target. The registry says most participants started on two drugs and another drug was required at milepost visits if not at goal. Mean of 2.8 blood-pressure medicines over follow-up.
-
Standard treatment
Intervention
Systolic target below 140 mm Hg (abstract and registry). The paper says medicines were adjusted toward 135 to 139 mm Hg, with a dose reduction below 130 at one visit or below 135 at two consecutive visits. Mean of 1.8 medicines. Both arms used the same study formulary. No separate intervention entity is recorded for this comparator strategy.
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, and findings from different contexts are not combined.
In plain words
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).
Source problem. A cited source is corrected. Check the sources before relying on this claim.
- 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.
- Outpatient trial clinics at 102 clinical sites. Nursing-home and assisted-living residents were not enrolled.
- United States, including Puerto Rico
- Adult, 50 years and over (28.2% of each arm aged 75 or over, per Table 1 of the paper)
SPRINT primary composite cardiovascular outcome Primary endpoint
243 of 4,678 participants in the Intensive treatment arm
- Measure
- Participants with at least one primary outcome event (count)
- Value
- 243 participants
- Reported as
- 243 (5.2%), 1.65% per year
- Interval
- Not applicable
- Denominator
- n = 4,678
- Time window
- Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20
319 of 4,683 participants in the Standard treatment arm
- Measure
- Participants with at least one primary outcome event (count)
- Value
- 319 participants
- Reported as
- 319 (6.8%), 2.19% per year
- Interval
- Not applicable
- Denominator
- n = 4,683
- Time window
- Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20
Intensive treatment compared with Standard treatment
- Measure
- Hazard ratio, intensive vs standard (Cox proportional-hazards, stratified by clinic, intention to treat)
- Value
- 0.75 ratio
- Reported as
- HR 0.75 (95% CI 0.64 to 0.89), P<0.001
- Interval
- 0.64 to 0.89
- Denominator
- Not applicable
- Time window
- Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20
Caveats
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.
Sources and citations (8)
-
Supports A Randomized Trial of Intensive versus Standard Blood-Pressure Control
- Locator
- Abstract, RESULTS, sentence 2: "hazard ratio with intensive treatment, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P<0.001"
- How it applies
- Abstract of the primary report, for the same population and follow-up as this context.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
0469472c893c84018c2444c15e0a5337926968dadfdd96ad3771f84a69c4e40c- Reuse basis
- Bibliographic metadata and short factual extraction with quotations under 25 words. Full text not redistributed.
-
Supports A Randomized Trial of Intensive versus Standard Blood-Pressure Control
- Locator
- Results, Clinical outcomes, para 1: "243 (1.65% per year) in the intensive-treatment group and 319 (2.19% per year) in the standard-treatment group"
- How it applies
- PMC author manuscript, not the version of record.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
14488a091a5a65b94db2789887ceff8e32d3c89d79db5656553e4429adf44be6- Reuse basis
- Bibliographic metadata and short factual extraction with quotations under 25 words. Full text not redistributed.
-
Supports A Randomized Trial of Intensive versus Standard Blood-Pressure Control
- Locator
- Table 2, "All participants" header row: "All participants (N = 4678) (N = 4683)"
- How it applies
- PMC author manuscript, not the version of record.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
14488a091a5a65b94db2789887ceff8e32d3c89d79db5656553e4429adf44be6- Reuse basis
- Bibliographic metadata and short factual extraction with quotations under 25 words. Full text not redistributed.
-
Supports Systolic Blood Pressure Intervention Trial (SPRINT)
- Locator
- resultsSection, primary outcome measure (posted results 243 of 4678 and 319 of 4683; HR 0.75, 0.64 to 0.89)
- How it applies
- The registry posted results equal the paper's figures.
- Retrieved
- Source effective date
- 2021-01-08
- Source state
- Current
- Snapshot hash
67c6195a32189455b608076fe2b490395dc14cc6e8bec40006e9a817b7f6d0ae- Reuse basis
- Registry record. The raw API JSON is committed at research/snapshots/ctgov-NCT01206062.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. This source's terms are unverified or reserve all rights, so any quotation stays short.
-
Background A Randomized Trial of Intensive versus Standard Blood-Pressure Control
- Locator
- Methods, Study population, para 1: "or an age of 75 years or older"
- How it applies
- Paper wording of the older-age criterion.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
14488a091a5a65b94db2789887ceff8e32d3c89d79db5656553e4429adf44be6- Reuse basis
- Bibliographic metadata and short factual extraction with quotations under 25 words. Full text not redistributed.
-
Background Systolic Blood Pressure Intervention Trial (SPRINT)
- Locator
- eligibilityModule.eligibilityCriteria: "Age greater than 75 years"
- How it applies
- Registry wording of the older-age criterion differs from the paper and is not reconciled.
- Retrieved
- Source effective date
- 2021-01-08
- Source state
- Current
- Snapshot hash
67c6195a32189455b608076fe2b490395dc14cc6e8bec40006e9a817b7f6d0ae- Reuse basis
- Registry record. The raw API JSON is committed at research/snapshots/ctgov-NCT01206062.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. This source's terms are unverified or reserve all rights, so any quotation stays short.
-
Background A Randomized Trial of Intensive versus Standard Blood-Pressure Control
- Locator
- Discussion, para 7: "persons with diabetes, those with prior stroke, and those younger than 50 years of age"
- How it applies
- The groups to whom the authors say the results do not generalize.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
14488a091a5a65b94db2789887ceff8e32d3c89d79db5656553e4429adf44be6- Reuse basis
- Bibliographic metadata and short factual extraction with quotations under 25 words. Full text not redistributed.
-
Background Erratum to "A Randomized Trial of Intensive versus Standard Blood-Pressure Control"
- Locator
- PubMed record of the 2017 erratum (PMID 29262284); the record has no text
- How it applies
- Shows that a correction exists. What it changes, and whether it affects these numbers, is unknown.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
0b35286e25986a2083bf5e24855520256cee0d8b58ccbff94f1f70961857ff34- Reuse basis
- Bibliographic metadata only. The erratum text was not reachable.
In plain words
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).
Source problem. A cited source is corrected. Check the sources before relying on this claim.
- 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.
- Outpatient trial clinics at 102 clinical sites. Nursing-home and assisted-living residents were not enrolled.
- United States, including Puerto Rico
- Adult, 50 years and over (28.2% of each arm aged 75 or over, per Table 1 of the paper)
Death from any cause Secondary endpoint
155 of 4,678 participants in the Intensive treatment arm
- Measure
- Participants who died (count)
- Value
- 155 participants
- Reported as
- 155 (3.3%), 1.03% per year
- Interval
- Not applicable
- Denominator
- n = 4,678
- Time window
- Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20
210 of 4,683 participants in the Standard treatment arm
- Measure
- Participants who died (count)
- Value
- 210 participants
- Reported as
- 210 (4.5%), 1.40% per year
- Interval
- Not applicable
- Denominator
- n = 4,683
- Time window
- Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20
Intensive treatment compared with Standard treatment
- Measure
- Hazard ratio, intensive vs standard
- Value
- 0.73 ratio
- Reported as
- HR 0.73 (95% CI 0.60 to 0.90), P=0.003
- Interval
- 0.6 to 0.9
- Denominator
- Not applicable
- Time window
- Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20
Caveats
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.
Sources and citations (5)
-
Supports A Randomized Trial of Intensive versus Standard Blood-Pressure Control
- Locator
- Abstract, RESULTS, sentence 3: "All-cause mortality was also significantly lower in the intensive-treatment group (hazard ratio, 0.73; 95% CI, 0.60 to 0.90; P=0.003)."
- How it applies
- Abstract of the primary report, for the same population and follow-up as this context.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
0469472c893c84018c2444c15e0a5337926968dadfdd96ad3771f84a69c4e40c- Reuse basis
- Bibliographic metadata and short factual extraction with quotations under 25 words. Full text not redistributed.
-
Supports A Randomized Trial of Intensive versus Standard Blood-Pressure Control
- Locator
- Results, Clinical outcomes, para 2: "155 in the intensive-treatment group and 210 in the standard-treatment group"
- How it applies
- PMC author manuscript, not the version of record.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
14488a091a5a65b94db2789887ceff8e32d3c89d79db5656553e4429adf44be6- Reuse basis
- Bibliographic metadata and short factual extraction with quotations under 25 words. Full text not redistributed.
-
Supports A Randomized Trial of Intensive versus Standard Blood-Pressure Control
- Locator
- Table 2, "All participants" header row: "All participants (N = 4678) (N = 4683)"
- How it applies
- PMC author manuscript, not the version of record.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
14488a091a5a65b94db2789887ceff8e32d3c89d79db5656553e4429adf44be6- Reuse basis
- Bibliographic metadata and short factual extraction with quotations under 25 words. Full text not redistributed.
-
Background A Randomized Trial of Intensive versus Standard Blood-Pressure Control
- Locator
- Discussion, para 7: "persons with diabetes, those with prior stroke, and those younger than 50 years of age"
- How it applies
- The groups to whom the authors say the results do not generalize.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
14488a091a5a65b94db2789887ceff8e32d3c89d79db5656553e4429adf44be6- Reuse basis
- Bibliographic metadata and short factual extraction with quotations under 25 words. Full text not redistributed.
-
Background Erratum to "A Randomized Trial of Intensive versus Standard Blood-Pressure Control"
- Locator
- PubMed record of the 2017 erratum (PMID 29262284); the record has no text
- How it applies
- Shows that a correction exists. What it changes, and whether it affects these numbers, is unknown.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
0b35286e25986a2083bf5e24855520256cee0d8b58ccbff94f1f70961857ff34- Reuse basis
- Bibliographic metadata only. The erratum text was not reachable.
Claims and evidence
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).
Eligibility: 6 inclusion criteria; 8 exclusion criteria
- Included
- Age 50 years or older
- Systolic blood pressure 130 to 180 mm Hg (paper). Registry upper limits by number of blood-pressure medicines: 0 to 1 medicines 130 to 180, up to 2 medicines 130 to 170, up to 3 medicines 130 to 160, up to 4 medicines 130 to 150.
- At least one increased cardiovascular risk criterion: clinical or subclinical cardiovascular disease other than stroke; chronic kidney disease (excluding polycystic kidney disease); Framingham 10-year cardiovascular risk of 15% or greater; or older age.
- Kidney criterion, worded differently by the sources and not reconciled: paper eGFR 20 to less than 60 ml/min/1.73 m2 (4-variable MDRD); registry "CKD, defined as eGFR 20 - 59 ml/min/1.73m2".
- Age criterion, worded differently by the sources and not reconciled: paper "an age of 75 years or older"; registry "Age greater than 75 years".
- Sex: all (registry)
- Excluded
- Diabetes mellitus
- Prior stroke (registry: "History of stroke (not CE or stenting)")
- Symptomatic heart failure within 6 months or left ventricular ejection fraction below 35% (registry)
- Proteinuria above the registry thresholds
- eGFR below 20 or end-stage renal disease (registry)
- Polycystic kidney disease (registry)
- One-minute standing systolic blood pressure below 110 mm Hg (registry)
- Pregnancy or trying to become pregnant (registry)
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.
Source problem. A cited source is corrected. Check the sources before relying on this claim.
Applies to Adult- 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.
- Outpatient trial clinics at 102 clinical sites. Nursing-home and assisted-living residents were not enrolled.
- United States, including Puerto Rico
- Adult, 50 years and over (28.2% of each arm aged 75 or over, per Table 1 of the paper)
- Certainty method
- Not assessed
- 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
- Next evidence check due
- Not scheduled
Sources and citations (3)
-
Supports A Randomized Trial of Intensive versus Standard Blood-Pressure Control
- 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"
- How it applies
- Abstract of the primary report, for the same population and follow-up as this context.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
0469472c893c84018c2444c15e0a5337926968dadfdd96ad3771f84a69c4e40c- Reuse basis
- Bibliographic metadata and short factual extraction with quotations under 25 words. Full text not redistributed.
-
Supports A Randomized Trial of Intensive versus Standard Blood-Pressure Control
- Locator
- Results, Study participants, para 1: "On August 20, 2015, the NHLBI director accepted a recommendation from the data and safety monitoring board"
- How it applies
- PMC author manuscript, not the version of record.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
14488a091a5a65b94db2789887ceff8e32d3c89d79db5656553e4429adf44be6- Reuse basis
- Bibliographic metadata and short factual extraction with quotations under 25 words. Full text not redistributed.
-
Supports A Randomized Trial of Intensive versus Standard Blood-Pressure Control
- Locator
- Results, Study participants, para 1: "after analyses of the primary outcome exceeded the monitoring boundary at two consecutive time points"
- How it applies
- PMC author manuscript, not the version of record.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
14488a091a5a65b94db2789887ceff8e32d3c89d79db5656553e4429adf44be6- Reuse basis
- Bibliographic metadata and short factual extraction with quotations under 25 words. Full text not redistributed.
Record details
- Record id
cardio:sprint- Content hash
4327425bbaf725de122d6c16ee8c69ac89b169ec1ff707b798a2120b905d1142