Systolic Blood Pressure Intervention Trial (SPRINT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
David Reboussin, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:
NCT01206062
First received: September 20, 2010
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Hypertension
Other: Intensive control of SBP
Other: Standard BP arm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Systolic Blood Pressure Intervention Trial

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • First occurrence of a myocardial infarction (MI), acute coronary syndrome (ACS), stroke, heart failure (HF), or CVD death [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Decline in renal function [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Development of end stage renal disease (ESRD), [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Dementia [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Decline in cognitive function [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Small vessel cerebral ischemic disease [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 9250
Study Start Date: October 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive BP Arm
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.
Other: 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 BP Arm
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
Other: Standard BP arm
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 Name: Control of SBP to a target of 140 mm Hg

Detailed Description:

SPRINT will randomize about 9250 participants aged ≥ 50 years with SBP ≥130 mm Hg and at least one additional CVD risk factor. The trial will compare 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 are <120 vs <140 mm Hg, respectively, to create a minimum mean difference of 10 mm Hg between the two randomized groups. The primary hypothesis is that CVD event rates will be lower in the intensive arm. Participants will be recruited at approximately 90 clinics within 5 clinical center networks (CCNs) over approximately a 2-year period, and will be followed for 4-6 years.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206062

Locations
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest Baptist Health
Investigators
Principal Investigator: David M. Reboussin, PhD Wake Forest School of Medicine
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 School of Medicine
Principal Investigator: Bill Cushman, MD Memphis VA Medical Center
  More Information

No publications provided

Responsible Party: David Reboussin, Principal Investigator, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier: NCT01206062     History of Changes
Other Study ID Numbers: 704, R01HL107257-01A1
Study First Received: September 20, 2010
Last Updated: May 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Wake Forest Baptist Health:
blood pressure
antihypertensive
systolic
diastolic
heart failure
myocardial infarction
stroke
chronic kidney disease
dementia
cognitive decline

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014