Clinical trial NCT01835249: Effect of Intense vs. Standard Hypertension Management on Nighttime Blood Pressure - an Ancillary Study to SPRINT
Official title: Effect of Intense vs. Standard Hypertension Management on Nighttime Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Nighttime blood pressure
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Wake Forest University
name: Louis Stokes VA Medical Center
name: University of Pennsylvania
name: Carolinas Medical Center
name: Mayo Clinic
name: University of Utah
name: Vanderbilt University
name: University of Alabama at Birmingham
name: Michael E. DeBakey VA Medical Center
name: Memphis VA Medical Center
name: Washington D.C. Veterans Affairs Medical Center
First posted: 2013-04-18
Enrollment: 897
Sex: ALL
Minimum age (years): 55
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Nighttime systolic blood pressure
timeFrame: 27 month follow up visit
Secondary outcomes:
measure: Night to day systolic BP ratio
timeFrame: 27 month follow up visit
measure: Timing of peak BP
timeFrame: 27 month follow up visit
measure: 24hr average systolic BP
timeFrame: 27 month follow up visit
measure: Blood pressure variability
timeFrame: 27 month follow up visit
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Washington
country: United States
facility: Washington DC VA Medical Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Louis Stokes Cleveland VA Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: Memphis VA
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: Houston VA
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Minnesota
name: Paul E Drawz, MD, MHS, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Drawz PE, Pajewski NM, Bates JT, Bello NA, Cushman WC, Dwyer JP, Fine LJ, Goff DC Jr, Haley WE, Krousel-Wood M, McWilliams A, Rifkin DE, Slinin Y, Taylor A, Townsend R, Wall B, Wright JT, Rahman M. Effect of Intensive Versus Standard Clinic-Based Hypertension Management on Ambulatory Blood Pressure: Results From the SPRINT (Systolic Blood Pressure Intervention Trial) Ambulatory Blood Pressure Study. Hypertension. 2017 Jan;69(1):42-50. doi: 10.1161/HYPERTENSIONAHA.116.08076. Epub 2016 Nov 14.