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Trial record 1 of 539 for:    Systolic Blood Pressure Intervention Trial
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Systolic Blood Pressure Intervention Trial (SPRINT)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01206062
First Posted: September 21, 2010
Last Update Posted: December 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Aging (NIA)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Neurological Disorders and Stroke (NINDS)
Wake Forest University Health Sciences
Information provided by (Responsible Party):
David Reboussin, Wake Forest University Health Sciences
September 20, 2010
September 21, 2010
July 13, 2017
December 4, 2017
December 4, 2017
October 2010
July 2016   (Final data collection date for 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 ]
First occurrence of a myocardial infarction (MI), acute coronary syndrome (ACS), stroke, heart failure (HF), or CVD death [ Time Frame: 6 years ]
Complete list of historical versions of study NCT01206062 on ClinicalTrials.gov Archive Site
  • Number of Participants With All-cause Mortality [ Time Frame: 6 years ]
  • Number of CKD Participants Who Experienced a 50% Decline From Baseline eGFR [ Time Frame: 6 years ]
  • Participants Who Developed End Stage Renal Disease [ Time Frame: 6 years ]
  • Dementia [ Time Frame: 6 years ]
    Additional data are being collected over the next year.
  • Decline in Cognitive Function [ Time Frame: 6 years ]
    Additional data are being collected over the next year.
  • Small Vessel Cerebral Ischemic Disease [ Time Frame: 6 years ]
    Additional data are being collected over the next year.
  • All-cause mortality [ Time Frame: 6 years ]
  • Decline in renal function [ Time Frame: 6 years ]
  • Development of end stage renal disease (ESRD), [ Time Frame: 6 years ]
  • Dementia [ Time Frame: 6 years ]
  • Decline in Cognitive Function [ Time Frame: 6 years ]
  • Small Vessel Cerebral Ischemic Disease [ Time Frame: 6 years ]
Not Provided
Not Provided
 
Systolic Blood Pressure Intervention Trial
Systolic Blood Pressure Intervention Trial
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
  • 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
  • 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 Name: Control of SBP to a target of 140 mm Hg
  • 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.
    Intervention: Drug: Intensive control of SBP
  • 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
    Intervention: Drug: Standard control of SBP
 
Active, not recruiting
9361
May 2018
July 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01206062
SPRINT
268200900040C-1-0-1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Yes
David Reboussin, Wake Forest University Health Sciences
National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute on Aging (NIA)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Wake Forest University Health Sciences
Principal Investigator: David M. Reboussin, PhD Wake Forest University Health Sciences
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
National Heart, Lung, and Blood Institute (NHLBI)
November 2017