Format

Send to:

Choose Destination
See comment in PubMed Commons below
Clin Trials. 2014 Oct;11(5):532-46. doi: 10.1177/1740774514537404. Epub 2014 Jun 5.

The design and rationale of a multicenter clinical trial comparing two strategies for control of systolic blood pressure: the Systolic Blood Pressure Intervention Trial (SPRINT).

Author information

  • 1Department of Biostatistical Sciences, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA wambrosi@wakehealth.edu.
  • 2Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.
  • 3Department of Social Sciences & Health Policy, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA.
  • 4Center for Healthcare Organization and Implementation Research, Bedford Veterans Affairs Hospital, Bedford, MA, USA.
  • 5Department of Internal Medicine, University of Utah and Veterans Affairs Salt Lake City Healthcare System, Salt Lake City, UT, USA.
  • 6Preventive Medicine Section, Veterans Affairs Medical Center, Memphis, TN, USA.
  • 7Clinical Applications and Prevention Branch, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD, USA.
  • 8Department of Epidemiology, Colorado School of Public Health, Aurora, CO, USA.
  • 9Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.
  • 10Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN, USA.
  • 11Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
  • 12Division of Cardiovascular Disease, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
  • 13Department of Biostatistical Sciences, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA.
  • 14Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.
  • 15Division of Nephrology and Hypertension, Department of Medicine, Case Western Reserve University, Cleveland, OH, USA.
  • 16Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA.

Abstract

BACKGROUND:

High blood pressure is an important public health concern because it is highly prevalent and a risk factor for adverse health outcomes, including coronary heart disease, stroke, decompensated heart failure, chronic kidney disease, and decline in cognitive function. Observational studies show a progressive increase in risk associated with blood pressure above 115/75 mm Hg. Prior research has shown that reducing elevated systolic blood pressure lowers the risk of subsequent clinical complications from cardiovascular disease. However, the optimal systolic blood pressure to reduce blood pressure-related adverse outcomes is unclear, and the benefit of treating to a level of systolic blood pressure well below 140 mm Hg has not been proven in a large, definitive clinical trial.

PURPOSE:

To describe the design considerations of the Systolic Blood Pressure Intervention Trial (SPRINT) and the baseline characteristics of trial participants.

METHODS:

The Systolic Blood Pressure Intervention Trial is a multicenter, randomized, controlled trial that compares two strategies for treating systolic blood pressure: one targets the standard target of <140 mm Hg, and the other targets a more intensive target of <120 mm Hg. Enrollment focused on volunteers of age ≥50 years (no upper limit) with an average baseline systolic blood pressure ≥130 mm Hg and evidence of cardiovascular disease, chronic kidney disease, 10-year Framingham cardiovascular disease risk score ≥15%, or age ≥75 years. The Systolic Blood Pressure Intervention Trial recruitment also targeted three pre-specified subgroups: participants with chronic kidney disease (estimated glomerular filtration rate <60 mL/min/1.73 m(2)), participants with a history of cardiovascular disease, and participants 75 years of age or older. The primary outcome is first the occurrence of a myocardial infarction (MI), acute coronary syndrome, stroke, heart failure, or cardiovascular disease death. Secondary outcomes include all-cause mortality, decline in kidney function or development of end-stage renal disease, incident dementia, decline in cognitive function, and small-vessel cerebral ischemic disease.

RESULTS:

Between 8 November 2010 and 15 March 2013, Systolic Blood Pressure Intervention Trial recruited and randomized 9361 people at 102 clinics, including 3331 women, 2648 with chronic kidney disease, 1877 with a history of cardiovascular disease, 3962 minorities, and 2636 ≥75 years of age.

LIMITATIONS:

Although the overall recruitment target was met, the numbers recruited in the high-risk subgroups were lower than planned.

CONCLUSIONS:

The Systolic Blood Pressure Intervention Trial will provide important information on the risks and benefits of intensive blood pressure treatment targets in a diverse sample of high-risk participants, including those with prior cardiovascular disease, chronic kidney disease, and those aged ≥75 years.

© The Author(s) 2014.

KEYWORDS:

Randomized clinical trial; blood pressure targets; brain structure and function; cardiovascular; cognition; geriatrics; hypertension; kidney; major adverse cardiovascular outcomes; stroke

PMID:
24902920
[PubMed - indexed for MEDLINE]
PMCID:
PMC4156910
Free PMC Article

Publication Types, MeSH Terms, Substances, Grant Support

Publication Types

MeSH Terms

Substances

Grant Support

PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for HighWire Icon for PubMed Central
    Loading ...
    Write to the Help Desk