Improving Outcomes for Hypertensive Children

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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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arkansas Children's Hospital

Little Rock, Arkansas, 72212, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

Severe HTN which in the opinion of the treating physician would prevent the subject from delaying changes in therapy to complete the study.
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.
Physical limitations prohibiting placement of the ABPM monitor.
Significant arrhythmias or known disruptions in cardiac output which may interfere with the monitor's ability to detect BP accurately.

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2015
First posted: Dec 6, 2011
Registry last updated: Sep 10, 2015

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.

Published trials that share one or more normalized conditions with this study.

Completed