Systolic Blood Pressure Intervention Trial (SPRINT) - Catalog

  • Name

    Systolic Blood Pressure Intervention Trial (SPRINT)

  • Accession Number

    HLB02021923b

  • Acronym

    SPRINT

  • Related studies
  • BSI Study IDs

    SPT

  • Is public use dataset

    False

  • Keywords
  • Ingestion Status
    Released
  • Has Study Datasets

    True

  • Has Specimens

    True

  • Specimen ID Type
    Coded
  • Study Website

    https://www.sprinttrial.org/public/dspHome.cfm

  • 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

  • Clinical Trial URLs
  • Study type
    Clinical Trial
  • Collection Type
    Open BioLINCC Study
  • Cohort type
    Adult
  • Interventions

    Drug: Intensive control of SBP

    Drug: Standard control of SBP

  • Study Open Date (Data)

    2019-06-24

  • Study Open Date (Specimens)

    2019-06-24

  • Date materials available

    2019-06-24

  • Last updated

    2020-07-22

  • Study period

    October 2010 – July 2016

  • Study Contacts

    Alfred.Cheung@hsc.utah.edu - Data Renewal Request, Data Request

    kille001@umn.edu - Data Renewal Request, Data Request

  • NHLBI Division

    DCVS

  • Classification
    Heart
  • HIV study classification
    non-HIV
  • COVID study classification
    non-COVID
  • Pre-Website # of Specimens Shipped

    None

  • # of Returned Specimens

    None

  • Primary Publication URLs
  • Conditions
    Hypertension
  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • Disease classification
  • Publications
  • Mat types
    DNA
    Plasma
    Serum
    Urine
    Urine Pellet/Sediment
  • Network

The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.

  • 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.

  • 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

    .

    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.