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

This study is not yet open for participant recruitment.
Verified April 2013 by Louis Stokes VA Medical Center
Sponsor:
Collaborators:
Wake Forest School of Medicine
Louis Stokes VA Medical Center
University of Pennsylvania
Carolinas Medical Center
Mayo Clinic
University of Utah
Vanderbilt University
University of Alabama at Birmingham
Houston VA Medical Center
Memphis VA Medical Center
Washington D.C. Veterans Affairs Medical Center
Information provided by (Responsible Party):
Paul Drawz, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01835249
First received: April 16, 2013
Last updated: April 18, 2013
Last verified: April 2013

April 16, 2013
April 18, 2013
June 2013
July 2015   (final data collection date for primary outcome measure)
Nighttime systolic blood pressure [ Time Frame: 27 month follow up visit ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01835249 on ClinicalTrials.gov Archive Site
  • Night to day systolic BP ratio [ Time Frame: 27 month follow up visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).
Same as current
Not Provided
Not Provided
 
Effect of Intense vs. Standard Hypertension Management on Nighttime Blood Pressure - an Ancillary Study to SPRINT
Effect of Intense vs. Standard Hypertension Management on Nighttime Blood Pressure

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Hypertension
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
600
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
55 Months and older
No
Contact: Paul E Drawz, MD, MHS, MS 612 625-5423 draw0003@umn.edu
United States
 
NCT01835249
1303M30341, 1303M30341
No
Paul Drawz, University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
  • Wake Forest School of Medicine
  • Louis Stokes VA Medical Center
  • University of Pennsylvania
  • Carolinas Medical Center
  • Mayo Clinic
  • University of Utah
  • Vanderbilt University
  • University of Alabama at Birmingham
  • Houston VA Medical Center
  • Memphis VA Medical Center
  • Washington D.C. Veterans Affairs Medical Center
Principal Investigator: Paul E Drawz, MD, MHS, MS University of Minnesota - Clinical and Translational Science Institute
Louis Stokes VA Medical Center
April 2013

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