Improving Outcomes for Hypertensive Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Arkansas Children's Hospital Research Institute
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01485783
First received: December 2, 2011
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Improving Outcomes for Hypertensive Children

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

Biospecimen Retention:   None Retained

none collected


Estimated Enrollment: 200
Study Start Date: November 2011
  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
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.

Criteria

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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485783

Contacts
Contact: Karen Redwine, MD 501-364-1847 redwinekarenm@uams.edu

Locations
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72212
Contact: Lee Howard, RN    501-364-6990    howardleee@uams.edu   
Contact: Pallavi Jaivijay    501-364-1492    pjaivijay@uams.edu   
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
Principal Investigator: Karen Redwine, MD Arkansas Children's Hospital Research Institute
  More Information

No publications provided

Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01485783     History of Changes
Other Study ID Numbers: ABPM Hypertensive Children
Study First Received: December 2, 2011
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Arkansas Children's Hospital Research Institute:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014