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

University of Minnesota (UMN)

Status: Completed

Conditions: Hypertension

Treatments: Other: Intensive BP Arm; Other: Standard BP arm

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01835249

1303M30341 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 897 patients

Sex: All

Ages: 55+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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897 participants in 2 patient groups

Intensive BP Arm

Experimental group

Description:

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.

Treatment:

Other: Intensive BP Arm

Standard BP Arm

Active Comparator group

Description:

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.

Treatment:

Other: Standard BP arm