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

NCT ID: NCT01835249

Last Updated: 2019-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 897 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2017-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intensive BP Arm

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Standard BP arm

Intervention Type: OTHER

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

Interventions

Intensive BP Arm

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

Intervention Type: OTHER

Standard BP arm

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 55 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University

OTHER

Sponsor Role: collaborator

Louis Stokes VA Medical Center

FED

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Carolinas Medical Center

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Michael E. DeBakey VA Medical Center

FED

Sponsor Role: collaborator

Memphis VA Medical Center

FED

Sponsor Role: collaborator

Washington D.C. Veterans Affairs Medical Center

FED

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul E Drawz, MD, MHS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Alabama Birmingham

Birmingham, Alabama, United States

Washington DC VA Medical Center

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

Mayo Clinic

Jacksonville, Florida, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Memphis VA

Memphis, Tennessee, United States

Vanderbilt University

Nashville, Tennessee, United States

Houston VA

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 27849563 (View on PubMed)

Other Identifiers

1303M30341

Identifier Type: OTHER

Identifier Source: secondary_id

1303M30341

Identifier Type: -

Identifier Source: org_study_id