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

Has Study Datasets

True

Has Specimens

True

Specimen ID Type

Coded

Study Website

https://www.sprinttrial.org/

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

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

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.

Subjects

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

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: 4,677 subjects
    Standard-treatment group: 4,682 subjects
     

    Last Modified: May 4, 2022, 2:51 p.m.
  • Age
      Standard Intensive All
    N % N % N %
    45<- 50 66 1.41 47 1.00 113 1.21
    50<- 55 393 8.39 375 8.02 768 8.21
    55<- 60 707 15.10 726 15.52 1433 15.31
    60<- 65 959 20.48 954 20.40 1913 20.44
    65<- 70 706 15.08 714 15.27 1420 15.17
    70<- 75 675 14.42 705 15.07 1380 14.75
    75<- 80 704 15.04 674 14.41 1378 14.72
    80<- 85 319 6.81 351 7.50 670 7.16
    85<- 90 153 3.27 131 2.80 284 3.03

    Last Modified: May 4, 2022, 2:51 p.m.
  • Sex
      Standard Intensive All
    N % N % N %
    Female 1648 35.20 1684 36.01 3332 35.60
    Male 3034 64.80 2993 63.99 6027 64.40

    Last Modified: May 4, 2022, 2:51 p.m.
  • Race
      Standard Intensive All
    N % N % N %
    White 3034 64.80 3037 64.93 6071 64.87
    Black 1481 31.63 1444 30.87 2925 31.25
    American Indian/Alaska Native 7 0.15 7 0.15 14 0.15
    Native Hawaiian/Pacific Islander 4 0.09 7 0.15 11 0.12
    Asian 31 0.66 45 0.96 76 0.81
    Other 101 2.16 115 2.46 216 2.31
    Mixed 24 0.51 22 0.47 46 0.49
     
      Standard Intensive All
    N % N % N %
    Hispanic 481 10.27 502 10.73 983 10.50
    Non-Hispanic 4201 89.73 4175 89.27 8376 89.50

     

    Last Modified: May 4, 2022, 2:51 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 of the BioLINCC handbook describes the components of the review process

  • Material Types
  • General Freeze/Thaw Status

    As of 05/04/2022, 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: May 4, 2022, 2:51 p.m.
  • Visits (Vials)

    03/03/2023

      Serum Plasma DNA Urine Pellet/Sediment Total
    Randomization 40,125 49,254 41,986 8,660 140,025
    Year 1 38,266 46,005 0 7,833 92,104
    Year 2 36,544 44,235 0 7,579 88,358
    Year 4 11,384 14,236 0 2,471 28,091
    Close Out 20,401 25,629 0 4,516 50,546

    Last Modified: March 3, 2023, 11:59 a.m.
  • Visits (Subjects)

    03/03/2023

      Serum
    Total number of subjects Average volume (ml) per subject
    Randomization 8,793 2.43
    Year 1 8,060 2.61
    Year 2 7,711 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 8,758 2.69
    Year 1 8,030 2.86
    Year 2 7,707 2.85
    Year 4 2,572 3.04
    Close Out 4,554 3.10
     
      Urine Pellet/Sediment
    Total number of subjects Average vials per subject
    Randomization 8,629 1.00
    Year 1 7,800 1.00
    Year 2 7,546 1.00
    Year 4 2,114 1.17
    Close Out 4,511 1.00
     
      DNA
    Total number of subjects Average mass (µg) per subject Average vials per subject
    Randomization 8,446 163.31 4.97

     

    Last Modified: March 3, 2023, 11:59 a.m.