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Completed

NCT Number: NCT01835249

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

55 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive BP Arm

Other

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

Standard BP arm

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

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

Registry information

Official study title

Effect of Intense vs. Standard Hypertension Management on Nighttime Blood Pressure

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 18, 2013
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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