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

This study is enrolling participants by invitation only.
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 - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01835249
First received: April 16, 2013
Last updated: May 24, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention Phase
Hypertension
Other: Intensive BP Arm
Other: Standard BP arm
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effect of Intense vs. Standard Hypertension Management on Nighttime Blood Pressure

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 600
Study Start Date: June 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Intensive BP Arm
Participants in the Intensive arm have a goal of SBP <120 mmHg.
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.
Other: Standard BP arm
Participants in the Standard BP arm have a goal of SBP <140 mmHg.

  Eligibility

Ages Eligible for Study:   55 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01835249

Locations
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States
United States, District of Columbia
Washington DC VA Medical Center
Washington, District of Columbia, United States
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States
United States, Ohio
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, United States
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Memphis VA
Memphis, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
United States, Texas
Houston VA
Houston, Texas, United States
United States, Utah
University of Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
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
Principal Investigator: Paul E Drawz, MD, MHS, MS University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01835249     History of Changes
Other Study ID Numbers: 1303M30341  1303M30341 
Study First Received: April 16, 2013
Last Updated: May 24, 2016
Health Authority: United States: Federal Government

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Hypertension
Nighttime blood pressure

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 26, 2016