Systolic Blood Pressure Intervention Trial

Summary

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.

Conditions

• Hypertension

Interventions

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.

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.

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Wake Forest University Health Sciences

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  lead NIH

Principal Investigators

• David M. Reboussin, PhD · Wake Forest University Health Sciences

• Jackson T Wright, MD · Case Western Reserve University

• Alfred Cheung, MD · University of Utah

• Suzanne Oparil, MD · University of Alabama at Birmingham

• Mike Rocco, MD · Wake Forest University Health Sciences

• Bill Cushman, MD · Memphis VA Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2016-07-31

Completion

2019-03-31

Countries

• United States

Study Locations