Systolic Blood Pressure Intervention Trial (SPRINT)

December 11, 2020 updated by: David Reboussin, National Heart, Lung, and Blood Institute (NHLBI)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9361

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Risk (one or more of the following)

  1. Presence of clinical or subclinical cardiovascular disease other than stroke
  2. CKD, defined as eGFR 20 - 59 ml/min/1.73m2
  3. A Framingham Risk Score for 10-year CVD risk ≥ 15%
  4. Age greater than 75 years

Exclusion Criteria:

  • 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
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive Control of SBP
Participants 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.
Drug: Intensive control of SBP

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.

Other Names:
  • Lower target for SBP
  • Comparison of standard SBP control to a target of 120 mm Hg
Active Comparator: Standard Control of SBP
Participants 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
Drug: Standard control of SBP
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.
Other Names:
  • Control of SBP to a target of 140 mm Hg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With All-cause Mortality
Time Frame: 6 years
6 years
Number of CKD Participants Who Experienced a 50% Decline From Baseline eGFR
Time Frame: 6 years
6 years
Participants Who Developed End Stage Renal Disease
Time Frame: 6 years
6 years
Number of Patients With All-cause Dementia
Time Frame: 6 years
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).
6 years
Small Vessel Cerebral Ischemic Disease
Time Frame: 4 years

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
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)
Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Jackson T Wright, MD, Case Western Reserve University
  • Principal Investigator: Alfred Cheung, MD, University of Utah
  • Principal Investigator: Suzanne Oparil, MD, University of Alabama At Birmingham
  • Principal Investigator: Mike Rocco, MD, Wake Forest University Health Sciences
  • Principal Investigator: Bill Cushman, MD, Memphis VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2010

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

September 20, 2010

First Submitted That Met QC Criteria

September 20, 2010

First Posted (Estimate)

September 21, 2010

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPRINT
  • 268200900040C-1-0-1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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