Ambulatory Blood Pressure Monitoring in Children
Completed
Conditions studied: Blood Pressure
In brief
Ambulatory Blood Pressure Monitoring (ABPM) potentially offers a superior way to screen children for entry into antihypertensive trials, assuring that only those with true hypertension are enrolled.10 In addition, ABPM offers a better method to measure response to drug therapy.11-16 The ABPM device most commonly used in children (Spacelabs 90217 - Issaquah, Washington) has not been independently validated for use in this population. In 1993, the British Hypertension Society (BHS) published a protocol for validating ABPM devices, including guidance for validation studies in children.17 More recently, the Working Group on Blood Pressure Monitoring of the European Society of Hypertension published revisions to these guidelines, but did not include children in this update.18 Unfortunately, the original BHS protocol suggests using a smaller group of children than the protocol outlines for adults. Since BP in children is more variable than in adults, this guidance is unlikely to be adequate for children. Hence, a large, stringent validation study needs to be conducted in a cohort of children using the methods similar to those used to validate the device in adults. Performance of the proposed validation study is needed to allow for the incorporation of ABPM into clinical trial designs of anti-hypertensives in children which will ultimately allow for more accurate identification of the hypertensive population and determination of response to therapy along with allowing for assessment of the chronobiologic profile of drug response over the dosing interval.9
Key facts
- Study ID
- NCT01070342
- Run by
- University Hospitals Cleveland Medical Center
- People needed
- 170
- Starts
- 2010-02-01
- Expected to finish
- 2011-02-01
- Last updated by the study team
- 2022-06-03
Who can join
Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 6-18 years inclusive.
- Mid-arm circumference measures 12-50 cm.
- Informed consent/assent.
You may not qualify if…
- Known AV fistula, unrepaired congenital heart disease, or other anatomical anomaly affecting cardiac output and/or normal cardiac circulation.
- Cardiac arrhythmias which may prevent the ABPM device from obtaining an accurate blood pressure measurement.
- Anatomical anomalies preventing measuring blood pressure in the non-dominant arm on multiple occasions.
- Ingestion of caffeine, tobacco exposure, or strenuous exercise within 30 minutes before study blood pressure measurements.
- Any condition that in the opinion of the principal investigator would affect the subject's ability to safely and accurately complete all study procedures.
Where it is running
- Arkansas Children's Hospital Research Institute — Little Rock, Arkansas, United States
- University of Louisville Research Foundation, Inc. — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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