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CompletedNCT01485783Updated Sep 10, 2015

Improving Outcomes for Hypertensive Children

An observational study in Hypertension, sponsored by Arkansas Children's Hospital Research Institute. Completed at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2015-09-10.

Sponsored by Arkansas Children's Hospital Research Institute · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
112
Ages
6 Years to 17 Years
Sex
All
01

Study summary

Approximately 200 children age 6 - \<18 years receiving medications for essential hypertension (HTN) will be recruited from the Pediatric Hypertension Clinic at the time of a routine clinic visit. Participating subjects will be asked to wear the ambulatory blood pressure monitor (ABPM) for 24 hours within 2 weeks of the qualifying visit. Measurements obtained with the ABPM will be compared to measurements obtained by routine clinical procedures documented in the subject's clinical chart. Kappa statistic will be utilized to compare differences in documented BP control between the two measures as well as changes in therapeutic management decisions by treating physicians with the addition of the ABPM readings. The overall goal is to confirm that ABPM leads to an increased detection of uncontrolled HTN along with a similar increase in adjustments increasing anti-hypertensive medication regimens.

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Conditions studied

  • Hypertension

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Keywords

  • Hypertension
03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's enrollment of 112 is below the median of 210 across 1,392 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Arkansas Children's Hospital Research Institute is the lead sponsor of 122 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Approximately 200 children age 6 - \<18 years receiving medications for essential HTN will be recruited from the Pediatric Hypertension Clinic at the time of a routine clinic visit.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 6-17 years (up to 18th birthday) receiving anti-hypertensive medication(s) by subject history at presentation for the qualifying clinic visit
  2. Arm circumference measurement of 15-50 cm (limits of SpaceLabs ABPM cuffs).

Exclusion criteria

Exclusion Criteria:

  1. Severe HTN which in the opinion of the treating physician would prevent the subject from delaying changes in therapy to complete the study.
  2. Secondary HTN from all causes (excluding obesity-related HTN). This includes but is not limited to renovascular HTN, chronic kidney disease, coarctation of the aorta, and monogenic forms of HTN.
  3. Physical limitations prohibiting placement of the ABPM monitor.
  4. Significant arrhythmias or known disruptions in cardiac output which may interfere with the monitor's ability to detect BP accurately.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
112 participants (actual)
Biospecimen retention
None retained
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Study locations

1 site
  • Arkansas Children's Hospital
    Little Rock, Arkansas 72212, United States
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2011, a primary completion of Jul 2013 and a completion of May 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 2, 2011
First posted
Dec 6, 2011
Start
Nov 2011
Primary completionActual
Jul 2013
CompletionActual
May 2015
Last update
Sep 10, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01485783
Responsible party
Sponsor
First posted
Dec 6, 2011
Start date
Nov 2011
Primary completion
Jul 2013
Completion
May 2015
Last update
Sep 10, 2015

Study contacts

Karen Redwine, MD
principal investigator · Arkansas Children's Hospital Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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