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

Completed · Not applicable

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT01835249

Run by

University of Minnesota

People needed

897

Starts

2013-06-01

Expected to finish

2017-07-01

Last updated by the study team

2019-01-25

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• eligible and enrolled in SPRINT at the 27 month follow up visit
• able and willing to provide informed consent

You may not qualify if…

• arm circumference >50cm
• shift worker or work regularly at night
• history of breast cancer requiring mastectomy
• end-stage renal disease

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• Washington DC VA Medical Center — Washington D.C., District of Columbia, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Louis Stokes Cleveland VA Medical Center — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Memphis VA — Memphis, Tennessee, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Houston VA — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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