Effect of Intense vs. Standard Hypertension Management on Nighttime Blood Pressure - an Ancillary Study to SPRINT
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|ClinicalTrials.gov Identifier: NCT01835249|
Recruitment Status : Enrolling by invitation
First Posted : April 18, 2013
Last Update Posted : May 4, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Other: Intensive BP Arm Other: Standard BP arm||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Intense vs. Standard Hypertension Management on Nighttime Blood Pressure|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||July 2019|
Experimental: Intensive BP Arm
Participants randomized into the Intensive BP arm will have a goal of SBP <120mmHg. Drugs will be added and/or titrated at each visit (monthly) to achieve SBP <120 mmHg. At periodic "milepost" visits, addition of another drug will be "required" if not at goal.
Other: Intensive BP Arm
Participants in the Intensive arm have a goal of SBP <120 mmHg.
Active Comparator: Standard BP Arm
Participants randomized into the Standard arm will have a goal of SBP <140 mm Hg. Intensify therapy if SBP ≥160 mmHg @ 1 visit; ≥140 mmHg @ 2 consecutive visits; Down-titration if SBP <130 mmHg @ 1 visit; <135 mmHg @ 2 consecutive visits.
Other: Standard BP arm
Participants in the Standard BP arm have a goal of SBP <140 mmHg.
- Nighttime systolic blood pressure [ Time Frame: 27 month follow up visit ]Ambulatory blood pressure monitoring will be performed within 3 weeks of the 27 month follow up visit. For the primary analysis, nighttime BP will be defined by narrow clock time (01:00 AM to 6:00 AM).
- Night to day systolic BP ratio [ Time Frame: 27 month follow up visit ]Ambulatory blood pressure monitoring will be performed within 3 weeks of the 27 month follow up visit. The night to day systolic BP ratio will be calculated using narrow clock times.
- Timing of peak BP [ Time Frame: 27 month follow up visit ]Ambulatory blood pressure monitoring will be performed within 3 weeks of the 27 month follow up visit. The timing of the peak BP will be calculated for each subject using cosinor rhythmometry analysis.
- 24hr average systolic BP [ Time Frame: 27 month follow up visit ]Ambulatory blood pressure monitoring will be performed within 3 weeks of the 27 month follow up visit. The average systolic BP will be calculated for each subject.
- Blood pressure variability [ Time Frame: 27 month follow up visit ]Ambulatory blood pressure monitoring will be performed within 3 weeks of the 27 month follow up visit. Blood pressure variability will be defined by the standard deviation of the systolic blood pressure and by calculating the average real variability (ARV).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835249
|United States, Alabama|
|University of Alabama Birmingham|
|Birmingham, Alabama, United States|
|United States, District of Columbia|
|Washington DC VA Medical Center|
|Washington, D.C., District of Columbia, United States|
|United States, Florida|
|Jacksonville, Florida, United States|
|United States, North Carolina|
|Carolinas Medical Center|
|Charlotte, North Carolina, United States|
|United States, Ohio|
|Louis Stokes Cleveland VA Medical Center|
|Cleveland, Ohio, United States|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States|
|United States, Tennessee|
|Memphis, Tennessee, United States|
|Nashville, Tennessee, United States|
|United States, Texas|
|Houston, Texas, United States|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States|
|Principal Investigator:||Paul E Drawz, MD, MHS, MS||University of Minnesota - Clinical and Translational Science Institute|