Ambulatory Blood Pressure Monitoring in Children (ABPM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01070342|
Recruitment Status : Unknown
Verified December 2009 by University Hospitals Cleveland Medical Center.
Recruitment status was: Not yet recruiting
First Posted : February 18, 2010
Last Update Posted : February 18, 2010
|Condition or disease||Intervention/treatment|
|Blood Pressure||Device: Spacelabs 90217|
The diagnosis and treatment of hypertension remains a challenge in children and adolescents.1 At present the diagnosis is made during medical encounters and depends on randomly applied auscultatory or oscillometric techniques.2 These measurements are influenced by multiple factors including diurnal variation, stress related effects (most notably the fact that the measurement is being performed in a physician's office or clinic), observer bias and the measurement process itself. In addition, these standard approaches provide little information regarding blood pressure and its variability in the patients' ambient environments.3,4 If and when a diagnosis of hypertension is made, lifestyle changes are often prescribed. In children and adolescents these recommendations meet with mixed results that often frustrate patients and families as well as caregivers. In most cases, where sufficient concern exists regarding the long-term health of end organs such as the heart, kidney, eye and brain, pharmacotherapy is recommended. Unfortunately, in these instances drugs are prescribed with little information to guide proper, age-related dosing or safety assessment. In studies conducted over the last decade more than half of the agents marketed for adults with hypertension failed to demonstrate sufficient activity in children and adolescents to meet regulatory requirements for labeling.5 While a significant amount of this apparent ambiguity appears to be related to the design of the studies assessing the efficacy and safety of these drugs in pediatric patients, perhaps a more significant problem in these studies was the determination of who is actually hypertensive in the first place. This supplement addresses this issue directly by introducing an innovative approach to the diagnosis of hypertension in children and adolescents. Once validated, ambulatory BP monitoring may be used to describe and model the chronobiological patterns of blood pressure among patients who have been recently diagnosed with hypertension using standard clinical criteria. This is a unique opportunity to assess treatment naïve patients and compare an innovative new approach to what is currently the gold standard.
The current project is designed specifically to validate the use of ambulatory blood pressure monitoring (ABPM) in children and adolescents so that it may be used as a clinical tool for unambiguously making the diagnosis of hypertension in this patient population and then be used to guide pharmacotherapeutic intervention. The use of ABPM in children was first documented in 19916 and has subsequently been employed in children as young as 2 months of age. Despite its adjunctive use by more than 60% of pediatric nephrologists in North America, the device currently used in the majority of pediatric practices and research centers has never been validated in a pediatric population.
In contrast, ABPM has become a world-wide standard for monitoring blood pressure in adults with suspected hypertension. It offers the advantages of multiple measurements of a dynamic process over a protracted period of time and permits the evaluation of diurnal patterns and nocturnal disease. It also offers distinct advantages in monitoring patients in their natural environment without observer bias while permitting objective assessment of apparent drug resistance and hypotensive events that might occur on therapy. Finally, ABPM measurements have been demonstrated to better correlate with cardiovascular morbidity and mortality than casual measurements.7 They also correlate with end organ damage in children.8 Performance of the proposed validation study is needed to allow for incorporation of ABPM into clinical trial designs related to the diagnosis and treatment of hypertension in children. ABPM will ultimately allow for more accurate determination of response to therapy and asses the chronobiologic profile of drug response over the dosing interval. Of the devices currently marketed, the Spacelabs 90217 offers the range of cuff sizes required by the pediatric population. Thus, it is this monitor that will be validated.
|Study Type :||Observational|
|Estimated Enrollment :||170 participants|
|Official Title:||Methodological Improvement in Measuring Efficacy Outcome in Antihypertensive Trials in Children|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||February 2011|
|Estimated Study Completion Date :||May 2012|
Chidren ages 6 to 18
Children ages 6 to 18 years will be available for participation in this multicenter study. Subjects will be enrolled from community based general pediatric clinics and other well-child care areas within participating hospitals and clinics of the four participating sites. Enrollment will continue until a total of 85 subjects from each age category (6-<12 years and ≥12- <18 years) successfully complete the study.
Device: Spacelabs 90217
Comparison of the two ways to measure blood pressure: using the ambulatory blood pressure device (Spacelabs 90217) versus the standard method of measuring blood pressure is done by using a stethoscope and a blood pressure cuff.
- To validate the Ambulatory Blood Pressure Monitoring device most commonly used in children (Spacelabs 90217 - Issaquah, Washington) has not been independently validated for use in this population. [ Time Frame: 30 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070342
|Contact: Jeffrey L. Blumer, Ph.D., M.D.||(216) 844-3310||Jeffrey.email@example.com|
|United States, Arkansas|
|Arkansas Children's Hospital Research Institute|
|Little Rock, Arkansas, United States, 72202|
|Contact: Laura James, M.D. 501-364-1418 firstname.lastname@example.org|
|Principal Investigator: Laura P. James, M.D.|
|Principal Investigator: Karen McNiece, M.D.|
|United States, Kentucky|
|University of Louisville Research Foundation, Inc.|
|Louisville, Kentucky, United States, 40202|
|Contact: Janice Sullivan, M.D. 502-629-5820 email@example.com|
|Principal Investigator: Janice Sullivan, M.D.|
|Principal Investigator:||Jeffrey L. Blumer, Ph.D., M.D.||Universtiy Hosptials Case Medical Center|