AzTrials
AzTrials

HypertensionSPRINTNCT01206062

Systolic Blood Pressure Intervention Trial

A study of Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Elevated blood pressure (BP) is an important public health concern. It is highly prevalent, the prevalence may be increasing, and it is a risk factor for several adverse health outcomes, especially coronary heart disease, stroke, heart failure, chronic kidney disease, and decline in cognitive function. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Hypertension
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,361 participants
Where
1 siteUnited States
Study dates
Oct 2010to Mar 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • At least 50 years old
  • Systolic blood pressure of
  • 130 - 180 mm Hg on 0 or 1 medication
  • 130 - 170 mm Hg on up to 2 medications
  • 130 - 160 mm Hg on up to 3 medications
  • 130 - 150 mm Hg on up to 4 medications
Show all 11Show fewer
  • Risk (one or more of the following)
  • Presence of clinical or subclinical cardiovascular disease other than stroke
  • CKD, defined as eGFR 20 - 59 ml/min/1.73m2
  • A Framingham Risk Score for 10-year CVD risk ≥ 15%
  • Age greater than 75 years

Who cannot join

  • An indication for a specific BP lowering medication that the person is not taking and the person has not been documented to be intolerant of the medication class.
  • Known secondary cause of hypertension that causes concern regarding safety of the protocol.
  • One minute standing SBP < 110 mm Hg.
  • Proteinuria in the following ranges (based on a measurement within the past 6 months)
  • 24 hour urinary protein excretion ≥1 g/day, or
  • 24 hour urinary albumin excretion ≥ 600 mg/day, or
Show all 25Show fewer
  • spot urine protein/creatinine ratio ≥ 1 g/g creatinine, or
  • spot urine albumin/creatinine ratio ≥ 600 mg/g creatinine, or
  • urine dipstick ≥ 2+ protein
  • Arm circumference too large or small to allow accurate blood pressure measurement with available devices
  • Diabetes mellitus,
  • History of stroke (not CE or stenting)
  • Diagnosis of polycystic kidney disease
  • Glomerulonephritis treated with or likely to be treated with immunosuppressive therapy
  • eGFR < 20 ml/min /1.73m2 or end-stage renal disease (ESRD)
  • Cardiovascular event or procedure (as defined above as clinical CVD for study entry) or hospitalization for unstable angina within last 3 months
  • Symptomatic heart failure within the past 6 months or left ventricular ejection fraction (by any method) < 35%
  • A medical condition likely to limit survival to less than 3 years or a malignancy other than non-melanoma skin cancer within the last 2 years
  • Any factors judged by the clinic team to be likely to limit adherence to interventions.
  • Failure to obtain informed consent from participant
  • Currently participating in another clinical trial (intervention study). Note: Patient must wait until the completion of his/her activities or the completion of the other trial before being screened for SPRINT.
  • Living in the same household as an already randomized SPRINT participant
  • Any organ transplant
  • Unintentional weight loss > 10% in last 6 months
  • Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Elevated blood pressure (BP) is an important public health concern. It is highly prevalent, the prevalence may be increasing, and it is a risk factor for several adverse health outcomes, especially coronary heart disease, stroke, heart failure, chronic kidney disease, and decline in cognitive function. The Systolic Blood Pressure Intervention Trial (SPRINT) is a 2-arm, multicenter, randomized clinical trial designed to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal than currently recommended will reduce cardiovascular disease (CVD) risk.

Read the detailed description

SPRINT strived to enroll about 9250 participants aged ≥ 50 years with SBP ≥130 mm Hg and at least one additional CVD risk factor. The trial compared the effects of randomization to a treatment program of an intensive SBP goal with randomization to a treatment program of a standard goal. Target SBP goals were <120 vs <140 mm Hg, respectively, to create a minimum mean difference of 10 mm Hg between the two randomized groups. The primary hypothesis was that CVD event rates would be lower in the intensive arm. Participants were recruited at approximately 90 clinics within 5 clinical center networks (CCNs) over approximately a 2-year period, and were followed for 4-6 years.

A total of 9361 participants were enrolled. NIH stopped the blood pressure intervention earlier than originally planned in order to quickly disseminate the significant preliminary results. Follow-up for cognitive and kidney outcomes continues during the post-intervention phase through May 2018.

Conditions
Hypertension
Being tested
Intensive control of SBP, Standard control of SBP
Keywords
blood pressure, antihypertensive, systolic, diastolic, heart failure, myocardial infarction, stroke, chronic kidney disease, dementia, cognitive decline
Medical subject headings
Hypertension, Systolic Murmurs, Heart Murmurs, Heart Failure, Myocardial Infarction, Stroke, Renal Insufficiency, Chronic, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive control of SBPDrug

    Also called Lower target for SBP, Comparison of standard SBP control to a target of 120 mm Hg

    Participants in the Intensive arm have a goal of SBP <120 mm Hg. Use of once-daily antihypertensive agents will be encouraged unless alternative frequency is indicated/necessary. One or more medications from the following classes of agents will be provided by the study for use in managing participants in both randomization groups to achieve study goals:

    Angiotension converting enzyme (ACE)-inhibitors Angiotension receptor blockers (ARBs) Direct vasodilators Thiazide-type diuretics Loop diuretics Potassium-sparing diuretics Beta-blockers Sustained-release calcium channel blockers (CCBs) Alpha1-receptor blockers Sympatholytics

    Combination products will be available, depending on cost, utility, or donations from pharmaceutical companies.

  • Standard control of SBPDrug

    Also called Control of SBP to a target of 140 mm Hg

    Participants in the Standard BP arm have a goal of SBP <140 mm Hg. The same medications used in the Intensive BP arm will be used for the Standard BP arm.

Study groups in NCT01206062
Study groupRoleWhat they receive
Intensive Control of SBPExperimentalParticipants randomized into the Intensive BP arm will have a goal of SBP <120 mm Hg. 2-drug therapy initiated in most Intensive participants; age ≥75 years and SBP 130-139 mm Hg on 0-1 drug; may begin with 1 drug, but add second at 1 month if SBP ≥130 mm Hg; drugs added and/or titrated at each visit (monthly) to achieve SBP <120 mm Hg; at periodic "milepost" visits: addition of another drug "required" if not at goal.
Receives: Drug: Intensive control of SBP
Standard Control of SBPActive comparatorParticipants randomized into the Standard arm will have a goal of SBP <140 mm Hg. Intensify therapy if SBP ≥160 mm Hg @ 1 visit; ≥140 mm Hg @ 2 consecutive visits; Down-titration if SBP <130 mm Hg @ 1 visit; <135 mm Hg @ 2 consecutive visits
Receives: Drug: Standard control of SBP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death

    Measured: 6 years

Secondary outcomes (5)

  1. Number of Participants With All-cause Mortality

    Measured: 6 years

  2. Number of CKD Participants Who Experienced a 50% Decline From Baseline eGFR

    Measured: 6 years

  3. Participants Who Developed End Stage Renal Disease

    Measured: 6 years

  4. Number of Patients With All-cause Dementia

    A 3-step process was used ascertain incident cases of all-cause dementia. First, to identify possible cases of dementia a brief Cognition Screening Battery was administered to all participants. Participants who score below the pre-designated screening cut-point for possible cognitive impairment during follow-up were administered a more comprehensive and detailed neurocognitive test battery (the Extended Cognitive Assessment Battery) plus the Functional Assessment Questionnaire (FAQ) which assesses impairments in daily living skills as a result of cognitive impairments. Last, all the above available tests and questionnaire data were submitted to a centralized, web-based system for adjudication by a panel of dementia experts who assigned final study classifications of probable dementia (PD), mild cognitive impairment (MCI) or no impairment (NI).

    Measured: 6 years

  5. Small Vessel Cerebral Ischemic Disease

    Change over 4 years in total white matter lesion volume from baseline Change over 4 years in total brain volume from baseline

    Because of the skewed distribution for WML volume, we first applied an inverse hyperbolic sine transformation (asinh), which is similar to a log transformation but can accommodate values of zero. Linear mixed models, including random effects for participant and MRI facility, were used to estimate the change in WML volume and TBV between the treatment groups, including time since randomization (in days) and intracranial volume as covariates. Because the inverse hyperbolic sine transformation is nonlinear, and given the context of a mixed-effects model, back-transformation to the original scale of cm3 is difficult

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionJul 2016
  4. Study completionMar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
9,361 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01206062
Sponsor's protocol ID
SPRINT
Other IDs
268200900040C-1-0-1
Acronym
SPRINT
Status last verified
Dec 2020
First submitted
20 Sep 2010
Last updated
8 Jan 2021
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Ambrosius WT, Sink KM, Foy CG, Berlowitz DR, Cheung AK, Cushman WC, Fine LJ, Goff DC Jr, Johnson KC, Killeen AA, Lewis CE, Oparil S, Reboussin DM, Rocco MV, Snyder JK, Williamson JD, Wright JT Jr, Whelton PK; SPRINT Study Research Group. The design and rationale of a multicenter clinical trial comparing two strategies for control of systolic blood pressure: the Systolic Blood Pressure Intervention Trial (SPRINT). Clin Trials. 2014 Oct;11(5):532-46. doi: 10.1177/1740774514537404. Epub 2014 Jun 5.

    PubMed 24902920

  • Ramsey TM, Snyder JK, Lovato LC, Roumie CL, Glasser SP, Cosgrove NM, Olney CM, Tang RH, Johnson KC, Still CH, Gren LH, Childs JC, Crago OL, Summerson JH, Walsh SM, Perdue LH, Bankowski DM, Goff DC; SPRINT Study Research Group. Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial. Clin Trials. 2016 Jun;13(3):319-30. doi: 10.1177/1740774516631735. Epub 2016 Feb 24.

    PubMed 26911833

  • SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9.

    PubMed 26551272

  • Meng X, Wang Y, Xiang Y, Xu X, Zhang X, Wang S, Tan Z, Zhao X, Wang K, Li M, Wang T, Zhao Z, Lu J, Xu M, Zheng J, Wang W, Ning G, Bi Y, Xu Y. Effects of intensive blood pressure control on cardio-kidney outcomes by KDIGO risk categories: a Post Hoc analysis of ACCORD-BP and SPRINT trials. Hypertens Res. 2026 Sep 3. doi: 10.1038/s41440-026-02792-5. Online ahead of print.

    PubMed 42693262

  • Charisis S, Pajewski NM, Price LR, Ho NH, Rashid T, Wang D, Zeng Y, Kutty NS, Bryan RN, Kern KC, Dickerson BC, Seshadri S, Nasrallah I, Launer L, Davatzikos C, Williamson JD, Habes M. Intensive versus standard blood pressure control and overall brain small vessel disease burden: a post-hoc analysis of the SPRINT randomized clinical trial. EClinicalMedicine. 2026 Aug 11;99:104143. doi: 10.1016/j.eclinm.2026.104143. eCollection 2026 Sep.

    PubMed 42614618

  • Wang S, Wang K, Tan Z, Zhang X, Xiang Y, Zhao X, Wang Y, Meng X, Wang T, Zhao Z, Li M, Zheng J, Xu M, Lu J, Bi Y, Xu Y. Cardiometabolic Renal Health Profile, Intensive Blood Pressure-Lowering Treatment and Cognitive Dysfunction: A Post Hoc Analysis of the SPRINT Trial. Diabetes Obes Metab. 2026 Aug 12. doi: 10.1111/dom.71217. Online ahead of print.

    PubMed 42587350

  • Pewowaruk R, Jaeger BC, Hughes TM, Upadhya B, Kitzman DW, Supiano MA, Gepner AD. Arterial Stiffness Mechanisms and Orthostatic Hypotension in SPRINT: A Randomized Controlled Trial. JACC Adv. 2026 May;5(5):102734. doi: 10.1016/j.jacadv.2026.102734. Epub 2026 Apr 11.

    PubMed 41965144

  • Liu Y, Lyu Y, Liu Y, Zhang J, Song Z, Chen K, Jiang Z, Yan H, Chen T, Li C. Individual participant-level analysis of four randomized clinical trials examined therapeutic effects of blood pressure lowering on hierarchical kidney outcome using win statistics. Kidney Int. 2026 Jul;110(1):178-189. doi: 10.1016/j.kint.2026.02.032. Epub 2026 Mar 26.

    PubMed 41903707

  • Wang S, Wang J, Wang Y, Xu X, Gu H, Xie W, Cai L, Zhang J, Wang T, Zhao Z, Li M, Zheng J, Xu M, Lu J, Bi Y, Xu Y. Intensive blood pressure control and risks of cognitive outcomes in patients with new-onset orthostatic hypotension. Age Ageing. 2026 Jan 3;55(1):afag005. doi: 10.1093/ageing/afag005.

    PubMed 41609319

  • Wang Y, Tang S, Li M, Chen M. Fluctuations in adherence to antihypertensive medication and cardiovascular outcomes: a secondary analysis of the SPRINT trial. Hypertens Res. 2026 Apr;49(4):1448-1459. doi: 10.1038/s41440-025-02538-9. Epub 2026 Jan 15.

    PubMed 41540116

  • Fan C, Wang X, Tao L, Liao Y, Jin L, Shi Q, Wang H, Shi Y, Chang T, Xue Y, Wang J, Yue W, Pan Y, Li Z, Wang Y, Xu M. Insulin Resistance and Blood Pressure Control on Cognitive Outcomes. Hypertension. 2026 Jan;83(1):199-211. doi: 10.1161/HYPERTENSIONAHA.125.24666. Epub 2025 Nov 26.

    PubMed 41293821

  • Chen WH, Yang C, Chen YT, Li ZJ, Guan K, Li JJ, Huang RC. Systolic Blood Pressure Time in Target Range and Acute Kidney Injury in Patients With Hypertension. Hypertension. 2025 Dec;82(12):2218-2226. doi: 10.1161/HYPERTENSIONAHA.125.25511. Epub 2025 Oct 9.

    PubMed 41064861

  • Li N, Yang Z, Yuan Q, Cheng W. A Risk Stratification Model for Predicting Benefits of Intensive Blood Pressure Treatment: Analysis of the Systolic Blood Pressure Intervention Trial. J Clin Hypertens (Greenwich). 2025 Aug;27(8):e70098. doi: 10.1111/jch.70098.

    PubMed 40751458

  • Chen X, Wang L, Jiang Y, Tang W, Xiao J, Deng W, Ren X, Li C. Interplay between triglyceride-glucose index and cardiovascular events in hypertensive patients with controlled blood pressure (SBP<140 mmHg): insights from the SPRINT trial. Front Endocrinol (Lausanne). 2025 Jul 16;16:1508667. doi: 10.3389/fendo.2025.1508667. eCollection 2025.

    PubMed 40741171

  • Pewowaruk R, Jaeger BC, Hughes TM, Upadhya B, Kitzman DW, Supiano MA, Gepner AD. Effects of Blood Pressure Control on Arterial Stiffness Mechanisms in SPRINT: A Randomized Controlled Trial. Hypertension. 2025 Jun;82(6):1004-1011. doi: 10.1161/HYPERTENSIONAHA.124.24816. Epub 2025 Apr 22.

    PubMed 40260539

Questions about this trial

What is this clinical trial studying?

A study of Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death (time frame: 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01206062, which also lists 137 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in