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NCT01835249 · ClinicalTrials.gov registry record · NA
Effect of Intense vs. Standard Hypertension Management on Nighttime Blood Pressure - an Ancillary Study to SPRINT
A NA study of Hypertension, sponsored by University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 897
- Enrollment target
- 10
- Study locations
NCT01835249 is a NA study of Hypertension that has completed, run by University of Minnesota. The registered enrollment target is 897 participants, below the 3,505-participant average among 470 other Hypertension trials with a reported enrollment target (74% lower). The trial reports 10 study locations across 9 states.
The verdict
NCT01835249, a NA study of Hypertension, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 897 participants
- Enrollment target
- 10
- Study locations
Study 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 co
Conditions Studied
Interventions
- OTHER Intensive BP Arm
- OTHER Standard BP arm
Study Locations (10)
Tennessee
- Memphis VA - Memphis
- Vanderbilt University - Nashville
Alabama
- University of Alabama Birmingham - Birmingham
District of Columbia
- Washington DC VA Medical Center - Washington D.C.
Florida
- Mayo Clinic - Jacksonville
North Carolina
- Carolinas Medical Center - Charlotte
Ohio
- Louis Stokes Cleveland VA Medical Center - Cleveland
Pennsylvania
- University of Pennsylvania - Philadelphia
Texas
- Houston VA - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 897 participants |
| Start Date | 2013-06 |
| Est. Completion | 2017-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01835249
The ClinicalTrials.gov registry entry for NCT01835249 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 897 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,505-participant average among 470 other Hypertension trials with a reported enrollment target (74% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Intensive BP Arm is the first listed.
NCT01835249 reports 10 study locations spanning 9 distinct geographic areas - top geographies include Tennessee, Alabama, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT01835249 about?
NCT01835249 is a clinical study titled "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 researc...
What is the current status of trial NCT01835249?
This trial is currently completed. It is a NA study. The enrollment target is 897 participants. The study started on 2013-06. Estimated completion is 2017-07.
What conditions does trial NCT01835249 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT01835249?
The interventions under investigation include: Intensive BP Arm (OTHER), Standard BP arm (OTHER).
Who is sponsoring clinical trial NCT01835249?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01835249 being conducted?
This trial has 10 study locations across Alabama, District of Columbia, Florida, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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