Ambulatory Blood Pressure Monitoring in Children

NCT01070342 | Completed

• 2 other identifiers: CTSAP1ULI-RR024989
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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.

  30 minutes

Study Arms (1)

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

Interventions

Spacelabs 90217 DEVICE

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.

Chidren ages 6 to 18

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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. In addition, enrollment will be dependent upon mean qualifying blood pressure and arm circumference such that a wide range of both are represented in each age group.

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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• University of California, San Diego: collaborator
• Arkansas Children's Hospital Research Institute: collaborator
• University of Cincinnati: collaborator
• University of Louisville: collaborator

Study Sites (2)

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Location

University of Louisville Research Foundation, Inc.

Louisville, Kentucky, 40202, United States

Location

Related Publications (21)

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  PMID: 15116145 BACKGROUND

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• Stergiou GS, Rarra VC, Yiannes NG. Changing relationship between home and office blood pressure with increasing age in children: the Arsakeion School study. Am J Hypertens. 2008 Jan;21(1):41-6. doi: 10.1038/ajh.2007.18.

  PMID: 18271071 BACKGROUND

• Benjamin DK Jr, Smith PB, Jadhav P, Gobburu JV, Murphy MD, Hasselblad V, Baker-Smith C, Califf RM, Li JS. Pediatric antihypertensive trial failures: analysis of end points and dose range. Hypertension. 2008 Apr;51(4):834-40. doi: 10.1161/HYPERTENSIONAHA.107.108886. Epub 2008 Mar 10.

  PMID: 18332283 BACKGROUND

• Portman RJ, Yetman RJ, West MS. Efficacy of 24-hour ambulatory blood pressure monitoring in children. J Pediatr. 1991 Jun;118(6):842-9. doi: 10.1016/s0022-3476(05)82193-6.

  PMID: 2040918 BACKGROUND

• White WB. Importance of aggressive blood pressure lowering when it may matter most. Am J Cardiol. 2007 Aug 6;100(3A):10J-16J. doi: 10.1016/j.amjcard.2007.05.009. Epub 2007 May 25.

  PMID: 17666192 BACKGROUND

• Belsha CW, Wells TG, McNiece KL, Seib PM, Plummer JK, Berry PL. Influence of diurnal blood pressure variations on target organ abnormalities in adolescents with mild essential hypertension. Am J Hypertens. 1998 Apr;11(4 Pt 1):410-7. doi: 10.1016/s0895-7061(98)00014-4.

  PMID: 9607378 BACKGROUND

• O'Brien E. Dipping comes of age: the importance of nocturnal blood pressure. Hypertension. 2009 Mar;53(3):446-7. doi: 10.1161/HYPERTENSIONAHA.108.127571. Epub 2009 Jan 26. No abstract available.

  PMID: 19171787 BACKGROUND

• Urbina E, Alpert B, Flynn J, Hayman L, Harshfield GA, Jacobson M, Mahoney L, McCrindle B, Mietus-Snyder M, Steinberger J, Daniels S; American Heart Association Atherosclerosis, Hypertension, and Obesity in Youth Committee. Ambulatory blood pressure monitoring in children and adolescents: recommendations for standard assessment: a scientific statement from the American Heart Association Atherosclerosis, Hypertension, and Obesity in Youth Committee of the council on cardiovascular disease in the young and the council for high blood pressure research. Hypertension. 2008 Sep;52(3):433-51. doi: 10.1161/HYPERTENSIONAHA.108.190329. Epub 2008 Aug 4. No abstract available.

  PMID: 18678786 BACKGROUND

• Weber MA, White WB, Giles TD, Bakris GL, Neutel JM, Smith DH, Davidai G. An effectiveness study comparing algorithm-based antihypertensive therapy with previous treatments using conventional and ambulatory blood pressure measurements. J Clin Hypertens (Greenwich). 2006 Apr;8(4):241-50; quiz 251-2. doi: 10.1111/j.1524-6175.2005.05221.x.

  PMID: 16596026 BACKGROUND

• Lacourciere Y, Neutel JM, Schumacher H. Comparison of fixed-dose combinations of telmisartan/hydrochlorothiazide 40/12.5 mg and 80/12.5 mg and a fixed-dose combination of losartan/hydrochlorothiazide 50/12.5 mg in mild to moderate essential hypertension: pooled analysis of two multicenter, prospective, randomized, open-label, blinded-end point (PROBE) trials. Clin Ther. 2005 Nov;27(11):1795-805. doi: 10.1016/j.clinthera.2005.11.014.

  PMID: 16368450 BACKGROUND

• Smith DH, Cramer MJ, Neutel JM, Hettiarachchi R, Koval S. Comparison of telmisartan versus losartan: meta-analysis of titration-to-response studies. Blood Press Monit. 2003 Jun;8(3):111-7. doi: 10.1097/00126097-200306000-00004.

  PMID: 12900588 BACKGROUND

• Coats AJ. Benefits of ambulatory blood pressure monitoring in the design of antihypertensive drug trials. Blood Press Monit. 1996 Apr;1(2):157-160.

  PMID: 10226219 BACKGROUND

• Guthrie R, Reggi DR, Plesher MM, Saini RK, Battikha JP. Efficacy and safety of fosinopril/hydrochlorothiazide combinations on ambulatory blood pressure profiles in hypertension. Fosinopril/Hydrochlorothiazide Investigators. Am J Hypertens. 1996 Apr;9(4 Pt 1):306-11. doi: 10.1016/0895-7061(95)00359-2.

  PMID: 8722432 BACKGROUND

• Verdecchia P, Gatteschi C, Benemio G, Boldrini F, Guerrieri M, Porcellati C. Duration of the antihypertensive action of atenolol, enalapril and placebo: a randomized within-patient study using ambulatory blood pressure monitoring. Int J Clin Pharmacol Ther Toxicol. 1988 Nov;26(11):570-4.

  PMID: 2854116 BACKGROUND

• O'Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, Altman DG, Bland M, Coats A, Atkins N. An outline of the revised British Hypertension Society protocol for the evaluation of blood pressure measuring devices. J Hypertens. 1993 Jun;11(6):677-9. doi: 10.1097/00004872-199306000-00013. No abstract available.

  PMID: 8397248 BACKGROUND

• O'Brien E, Pickering T, Asmar R, Myers M, Parati G, Staessen J, Mengden T, Imai Y, Waeber B, Palatini P, Gerin W; Working Group on Blood Pressure Monitoring of the European Society of Hypertension. Working Group on Blood Pressure Monitoring of the European Society of Hypertension International Protocol for validation of blood pressure measuring devices in adults. Blood Press Monit. 2002 Feb;7(1):3-17. doi: 10.1097/00126097-200202000-00002. No abstract available.

  PMID: 12040236 BACKGROUND

• National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004 Aug;114(2 Suppl 4th Report):555-76. No abstract available.

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  BACKGROUND

• Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ; Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Recommendations for blood pressure measurement in humans and experimental animals: Part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Hypertension. 2005 Jan;45(1):142-61. doi: 10.1161/01.HYP.0000150859.47929.8e. Epub 2004 Dec 20.

  PMID: 15611362 BACKGROUND

Study Officials

• Jeffrey L. Blumer, Ph.D., M.D.

  Universtiy Hosptials Case Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 18, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: June 3, 2022

Record last verified: 2022-05

Locations

US (2)