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

NCT01835249 | Completed

• 1 other identifier: 1303M30341
• Study Type: interventional
• Target: 897
• Locations: 1 country
• Sites: 10

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.

Conditions

Hypertension

Keywords

Hypertension; Nighttime blood pressure

Outcome Measures

Primary Outcomes (1)

• Nighttime systolic blood pressure

  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).

  27 month follow up visit

Secondary Outcomes (4)

• Night to day systolic BP ratio

  27 month follow up visit

• Timing of peak BP

  27 month follow up visit

• 24hr average systolic BP

  27 month follow up visit

• Blood pressure variability

  27 month follow up visit

Study Arms (2)

Intensive BP Arm

EXPERIMENTAL

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

Standard BP Arm

ACTIVE COMPARATOR

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

Interventions

Intensive BP Arm OTHER

Participants in the Intensive arm have a goal of SBP \<120 mmHg.

Intensive BP Arm

Standard BP arm OTHER

Participants in the Standard BP arm have a goal of SBP \<140 mmHg.

Standard BP Arm

Eligibility Criteria

• Age: 55 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Minnesota: lead
• Wake Forest University: collaborator
• Louis Stokes VA Medical Center: collaborator
• University of Pennsylvania: collaborator
• Carolinas Medical Center: collaborator
• Mayo Clinic: collaborator
• University of Utah: collaborator
• Vanderbilt University: collaborator
• University of Alabama at Birmingham: collaborator
• Michael E. DeBakey VA Medical Center: collaborator
• Memphis VA Medical Center: collaborator
• Washington D.C. Veterans Affairs Medical Center: collaborator

Study Sites (10)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

Washington DC VA Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, 44129, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Memphis VA

Memphis, Tennessee, 38104, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

Houston VA

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• 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.

  PMID: 27849563 RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paul E Drawz, MD, MHS, MS

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 18, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 25, 2019

Record last verified: 2019-01

Locations

US (10)