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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01835249
Recruitment Status : Completed
First Posted : April 18, 2013
Last Update Posted : January 25, 2019
Sponsor:
Collaborators:
Wake Forest University
Louis Stokes VA Medical Center
University of Pennsylvania
Carolinas Medical Center
Mayo Clinic
University of Utah
Vanderbilt University
University of Alabama at Birmingham
VA Medical Center, Houston
Memphis VA Medical Center
Washington D.C. Veterans Affairs Medical Center
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE April 16, 2013
First Posted Date  ICMJE April 18, 2013
Last Update Posted Date January 25, 2019
Study Start Date  ICMJE June 2013
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2013)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2013)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Intense vs. Standard Hypertension Management on Nighttime Blood Pressure - an Ancillary Study to SPRINT
Official Title  ICMJE Effect of Intense vs. Standard Hypertension Management on Nighttime Blood Pressure
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Other: Intensive BP Arm
    Participants in the Intensive arm have a goal of SBP <120 mmHg.
  • Other: Standard BP arm
    Participants in the Standard BP arm have a goal of SBP <140 mmHg.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Intensive BP Arm
  • 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.
    Intervention: Other: Standard BP arm
Publications * 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. Epub 2016 Nov 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2019)
897
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2013)
600
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01835249
Other Study ID Numbers  ICMJE 1303M30341
1303M30341 ( Other Identifier: University of Minnesota IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE
  • Wake Forest University
  • Louis Stokes VA Medical Center
  • University of Pennsylvania
  • Carolinas Medical Center
  • Mayo Clinic
  • University of Utah
  • Vanderbilt University
  • University of Alabama at Birmingham
  • VA Medical Center, Houston
  • Memphis VA Medical Center
  • Washington D.C. Veterans Affairs Medical Center
Investigators  ICMJE
Principal Investigator: Paul E Drawz, MD, MHS, MS University of Minnesota
PRS Account University of Minnesota
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP