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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Other: Standard BP arm; Other: Intensive BP Arm

• Registration Number: NCT01835249
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-04-16
• Study First Submitted QC: 2013-04-16
• Study First Posted: 2013-04-18
• Study Start: 2013-06
• Primary Completion: 2017-06
• Study Completion: 2017-07
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-23
• Last Update Posted: 2019-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 897

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard BP Arm	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.
Intensive BP Arm	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.

Primary Outcome Measures

Name	Time	Method
Nighttime systolic blood pressure	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).

Secondary Outcome Measures

Name	Time	Method
Timing of peak BP	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.
Night to day systolic BP ratio	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.
Blood pressure variability	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).
24hr average systolic BP	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.

Trial Locations

Locations (10)

Washington DC VA Medical Center; 🇺🇸 Washington, District of Columbia, United States

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Memphis VA; 🇺🇸 Memphis, Tennessee, United States

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

Houston VA; 🇺🇸 Houston, Texas, United States

Louis Stokes Cleveland VA Medical Center; 🇺🇸 Cleveland, Ohio, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States