Effect of Intense vs. Standard Hypertension Management on Nighttime Blood Pressure - an Ancillary Study to SPRINT

Summary

Hypertension is a major risk factor for cardiovascular and renal disease, and a leading cause of premature mortality worldwide. Early hypertension studies showed that treating elevated blood pressure (BP) reduces patients' risk of cardiovascular disease and all-cause mortality. In subsequent research, patients achieved greater improvement in cardiovascular outcomes when their treatment was aimed at a moderate systolic BP target (\<150mmHg) than at higher targets. Although observational data suggest that even lower BP targets may be beneficial, this has not been seen in randomized trials; instead, "intense" treatment of hypertension (i.e., to a target systolic BP \<120mmHg) was found to have no effect on participants' risk for renal disease, cardiovascular disease, or all-cause mortality.

One potential explanation for this apparent lack of benefit of intense BP targets is that the study protocols targeted reductions in clinic BP rather than ambulatory BP. Ambulatory BP monitoring (ABPM) allows for assessment of BP throughout the day and night. Of all the BP measurements, nighttime systolic BP appears to be the best predictor of cardiovascular disease and all-cause mortality. Because recent trials assessing intense BP targets did not include ambulatory BP measurements, the effect of intensive treatment on nighttime BP is largely unknown.

To address this important gap in knowledge, we will conduct ABPM in 600 participants as part of an ancillary study to the ongoing Systolic Blood Pressure Intervention Trial (SPRINT). The goal of the ancillary study is to evaluate the effect of intensive vs. standard clinic based BP targets on nighttime BP (primary outcome), as well as night/day BP ratio, timing of peak BP, 24hr BP, and BP variability (secondary outcomes). The SPRINT trial includes approximately 9250 participants at high risk for cardiovascular disease.

The investigators hypothesize that intense targeting of clinic systolic BP does not lower nighttime systolic BP compared to a standard target.

Conditions

• Hypertension

Interventions

OTHER

Intensive BP Arm

Participants in the Intensive arm have a goal of SBP \<120 mmHg.

OTHER

Standard BP arm

Participants in the Standard BP arm have a goal of SBP \<140 mmHg.

Sponsors & Collaborators

• Wake Forest University

  collaborator OTHER

• Louis Stokes VA Medical Center

  collaborator FED

• University of Pennsylvania

  collaborator OTHER

• Carolinas Medical Center

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Michael E. DeBakey VA Medical Center

  collaborator FED

• Memphis VA Medical Center

  collaborator FED

• Washington D.C. Veterans Affairs Medical Center

  collaborator FED

• University of Minnesota

  lead OTHER

Principal Investigators

• Paul E Drawz, MD, MHS, MS · University of Minnesota

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

55 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2017-06-30

Completion

2017-07-31

Countries

• United States

Study Locations