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| ID | Type | Description | Link |
|---|---|---|---|
| 1303M30341 | Other Identifier | University of Minnesota IRB |
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| Name | Class |
|---|---|
| Wake Forest University | OTHER |
| Louis Stokes VA Medical Center | FED |
| University of Pennsylvania | OTHER |
| Carolinas Medical Center |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive BP Arm | Experimental | 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. |
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| Standard BP Arm | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive BP Arm | Other | Participants in the Intensive arm have a goal of SBP <120 mmHg. |
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| Measure | Description | Time Frame |
|---|---|---|
| Nighttime systolic blood pressure | 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). | 27 month follow up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Night to day systolic BP ratio | 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. | 27 month follow up visit |
| Timing of peak BP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul E Drawz, MD, MHS, MS | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Washington DC VA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27849563 | Result | 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. |
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| OTHER |
| Mayo Clinic | OTHER |
| University of Utah | OTHER |
| Vanderbilt University | OTHER |
| University of Alabama at Birmingham | OTHER |
| Michael E. DeBakey VA Medical Center | FED |
| Memphis VA Medical Center | FED |
| Washington D.C. Veterans Affairs Medical Center | FED |
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| Standard BP arm | Other | Participants in the Standard BP arm have a goal of SBP <140 mmHg. |
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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. |
| 27 month follow up visit |
| 24hr average systolic BP | 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. | 27 month follow up visit |
| Blood pressure variability | 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). | 27 month follow up visit |
| Washington D.C. |
| District of Columbia |
| 20422 |
| United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Louis Stokes Cleveland VA Medical Center | Cleveland | Ohio | 44129 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Memphis VA | Memphis | Tennessee | 38104 | United States |
| Vanderbilt University | Nashville | Tennessee | 37235 | United States |
| Houston VA | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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