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Ambulatory Blood Pressure Monitoring in Hypertension

This study has been completed.
Sponsor:
Collaborator:
Pediatric Pharmacology Research Units Network
Information provided by:
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00166634
First received: September 9, 2005
Last updated: January 10, 2011
Last verified: January 2011
History of Changes
  Purpose

The primary objective of this proposal is to demonstrate that ABPM can be used to improve study design for interventional trials in children with hypertension.


Condition Intervention
Hypertension
 Procedure: Ambulatory Blood Pressure Monitoring (ABPM)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: The Role of Ambulatory Blood Pressure Monitoring (ABPM) in Interventional Trials Conducted in Children With Hypertension

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • The primary outcome measure is ABPM to examine borderline high blood pressure, mild or untreated blood pressure in children captured within a 24 hour period on two occasions within a week.

Estimated Enrollment: 126
Study Start Date: July 2003
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Detailed Description:

ABPM is a standard technique in adult antihypertensive trials to study the magnitude and duration of effect of investigational drugs. These methods are needed for pediatric studies. Before such methods can be developed, preliminary information must be collected to demonstrate that the device can be used for antihypertensive studies in children (i.e, to determine the dropout rate following the first ABP study, to determine the frequency of white coat hypertension in a selected population, to compare casual (office) blood pressures commonly used to diagnose hypertension in children with those obtained by ABPM, and to assess the placebo effect in children with borderline and mild hypertension).

All participants will be asked to complete 24 hour ABPM on two occasions within one week. During the ABPM parents and children will be asked to keep a diary recording the times that the child slept. A crossover design will be used, where subjects are initially randomized to either drug or placebo and then will be crossed over to the other intervention at a set time during the study.

  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female children 5-16 years of age.
  • Borderline or mild systolic and or diastolic hypertension as defined by 1996 Task Force criteria.
  • No current drug therapy for hypertension being taken.
  • Must be ambulatory and willing to wear an ABP monitor for 24 hours
  • Agree to refrain from swimming, showering and other activities that might result in damage to ABP monitor during the two 24 hour intervals that the monitor is worn.
  • Standing height between 45 inches and 73 inches
  • Informed parental consent and patient assent.

Exclusion Criteria:

  • Severe or life threatening hypertension.
  • Any drug therapy that may raise or lower the blood pressure.
  • Any severe bleeding disorder or concurrent treatment with anticoagulant medications
  • Non-ambulatory
  • Significant arrhythmia
  • Previous history of significant non-compliance with prescribed medical care.
  • Any other disease that, in the opinion of the investigator, might interfere with the accurate measurement of the blood pressure or place the subject at risk unnecessarily.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166634

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Ohio
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Utah
University of Utah--Primary Children's Medical Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Pediatric Pharmacology Research Units Network
  More Information

Additional Information:
Pediatric Pharmacology Research Units Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Leah Dawson, Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00166634     History of Changes
Other Study ID Numbers: PPRU 10668s
Study First Received: September 9, 2005
Last Updated: January 10, 2011
Health Authority: United States: Federal Government

Keywords provided by Arkansas Children's Hospital Research Institute:
Hypertension
ABPM
Ambulatory Blood Pressure Monitoring

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013