Blood PressureABPMNCT01070342
Ambulatory Blood Pressure Monitoring in Children
An observational study of Blood Pressure, run by University Hospitals Cleveland Medical Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Spacelabs 90217
- Type of treatment
- Medical device
- How many people
- 170 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2010to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Age 6-18 years inclusive.
- Mid-arm circumference measures 12-50 cm.
- Informed consent/assent.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
University of Louisville Research Foundation, Inc.
Louisville, Kentucky, 40202
About this study
Official title: Methodological Improvement in Measuring Efficacy Outcome in Antihypertensive Trials in Children
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
Read the detailed description
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.
- Conditions
- Blood Pressure
- Being tested
- Spacelabs 90217
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spacelabs 90217Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Spacelabs 90217 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, Arkansas Children's Hospital Research Institute, University of Cincinnati, University of Louisville
- Responsible party
- Sponsor
- Investigators
- Jeffrey L. Blumer, Ph.D., M.D., Principal investigator, Universtiy Hosptials Case Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070342
- Sponsor's protocol ID
- CTSAP1
- Other IDs
- ULI-RR024989
- Acronym
- ABPM
- Status last verified
- May 2022
- First submitted
- 17 Feb 2010
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Whelton PK, Beevers DG, Sonkodi S. Strategies for improvement of awareness, treatment and control of hypertension: results of a panel discussion. J Hum Hypertens. 2004 Aug;18(8):563-5. doi: 10.1038/sj.jhh.1001738.
PubMed 15116145Park MK, Menard SM. Accuracy of blood pressure measurement by the Dinamap monitor in infants and children. Pediatrics. 1987 Jun;79(6):907-14.
PubMed 3588145Stergiou GS, Baibas NM, Gantzarou AP, Skeva II, Kalkana CB, Roussias LG, Mountokalakis TD. Reproducibility of home, ambulatory, and clinic blood pressure: implications for the design of trials for the assessment of antihypertensive drug efficacy. Am J Hypertens. 2002 Feb;15(2 Pt 1):101-4. doi: 10.1016/s0895-7061(01)02324-x.
PubMed 11863243Stergiou 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.
PubMed 18271071Benjamin 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.
PubMed 18332283Portman 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.
PubMed 2040918White 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.
PubMed 17666192Belsha 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.
PubMed 9607378O'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.
PubMed 19171787Urbina 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.
PubMed 18678786Weber 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.
PubMed 16596026Lacourciere 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.
PubMed 16368450Smith 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.
PubMed 12900588Coats AJ. Benefits of ambulatory blood pressure monitoring in the design of antihypertensive drug trials. Blood Press Monit. 1996 Apr;1(2):157-160.
PubMed 10226219Guthrie 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.
PubMed 8722432
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methodological Improvement in Measuring Efficacy Outcome in Antihypertensive Trials in Children
- ClinicalTrials.gov ID
- NCT01070342
- Acronym / sponsor ID
- ABPM / CTSAP1
- Conditions
- Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- University of California, San Diego, Arkansas Children's Hospital Research Institute, University of Cincinnati, University of Louisville
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 18 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidren ages 6 to 18 | – | Device: Spacelabs 90217Children 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Age 6-18 years inclusive.
- Mid-arm circumference measures 12-50 cm.
- Informed consent/assent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spacelabs 90217Comparison 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. | Device | Chidren ages 6 to 18 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Background: PubMed 15116145Whelton PK, Beevers DG, Sonkodi S. Strategies for improvement of awareness, treatment and control of hypertension: results of a panel discussion. J Hum Hypertens. 2004 Aug;18(8):563-5. doi: 10.1038/sj.jhh.1001738.
- Background: PubMed 3588145Park MK, Menard SM. Accuracy of blood pressure measurement by the Dinamap monitor in infants and children. Pediatrics. 1987 Jun;79(6):907-14.
- Background: PubMed 11863243Stergiou GS, Baibas NM, Gantzarou AP, Skeva II, Kalkana CB, Roussias LG, Mountokalakis TD. Reproducibility of home, ambulatory, and clinic blood pressure: implications for the design of trials for the assessment of antihypertensive drug efficacy. Am J Hypertens. 2002 Feb;15(2 Pt 1):101-4. doi: 10.1016/s0895-7061(01)02324-x.
- Background: PubMed 18271071Stergiou 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.
- Background: PubMed 18332283Benjamin 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.
- Background: PubMed 2040918Portman 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.
- Background: PubMed 17666192White 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.
- Background: PubMed 9607378Belsha 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.
- Background: PubMed 19171787O'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.
- Background: PubMed 18678786Urbina 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.
- Background: PubMed 16596026Weber 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.
- Background: PubMed 16368450Lacourciere 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey L. Blumer, Ph.D., M.D. principal investigator
Universtiy Hosptials Case Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by University Hospitals Cleveland Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01070342, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.