Cardiovascular DiseasesNCT00005421
Blood Pressure Tracking--Childhood to Young Adulthood
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To extend analyses of blood pressure (BP) tracking to a period that spanned childhood and young adulthood. Data were used from the same cohort of 339 children who had been followed for nine to twelve years in a previous study. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1992to Mar 1995
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To extend analyses of blood pressure (BP) tracking to a period that spanned childhood and young adulthood. Data were used from the same cohort of 339 children who had been followed for nine to twelve years in a previous study.
Read the detailed description
BACKGROUND:
Blood pressure measurements in childhood and young adulthood are less predictive of future levels than those taken in middle age. In part, this may be due to the fact that within-person variability appears to make up a larger proportion of total variability in childhood than adulthood. Previous work on an NHLBI supported grant indicated that repeated blood pressure measurements and visits led to higher childhood tracking correlations over a period of three years.
DESIGN NARRATIVE:
Follow-up data were used as well as multiple visits which reduced the large within-person variability of blood pressure measurements and improved the tracking correlations. In addition, 'true' or 'corrected' tracking correlations were provided by eliminating the effects of random measurement error. The effects were examined of time-varying covariates on both the observed and true tracking correlations. Besides computing tracking correlations, predictive values were computed for young adult blood pressure given childhood levels. This was the probability that a young adult's true blood pressure was above a specific cutpoint conditional on childhood blood pressure. These values were validated using data from the Fels Longitudinal Study, which included serial blood pressure measurements over the age range in the study. The prediction models were also derived including terms for covariates such as age, sex, height and weight. From these models nomograms were constructed which were useful to physicians for prognostic purposes. Thus, because of the unique multiple-visit approach used in these data, the effect of random measurement error was eliminated. These methodologic improvements strengthened the usefulness of blood pressure screening in childhood to detect those at high risk of developing hypertension.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1992
- Study completionMar 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Nancy Cook, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005421
- Sponsor's protocol ID
- 4339
- Other IDs
- R03HL048289
- Status last verified
- Mar 2005
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Cook NR, Gillman MW, Rosner BA, Taylor JO, Hennekens CH. Prediction of young adult blood pressure from childhood blood pressure, height, and weight. J Clin Epidemiol. 1997 May;50(5):571-9. doi: 10.1016/s0895-4356(97)00046-2.
PubMed 9180649Cook NR. Estimating predictive values for blood pressure measurements from multivariate regression models with covariates. Stat Med. 1996 Oct 15;15(19):2013-28. doi: 10.1002/(SICI)1097-0258(19961015)15:193.0.CO;2-Y.
PubMed 8896136Gillman MW, Cook NR. Blood pressure measurement in childhood epidemiological studies. Circulation. 1995 Aug 15;92(4):1049-57. doi: 10.1161/01.cir.92.4.1049.
PubMed 7641339Cook NR, Cohen J, Hebert PR, Taylor JO, Hennekens CH. Implications of small reductions in diastolic blood pressure for primary prevention. Arch Intern Med. 1995 Apr 10;155(7):701-9.
PubMed 7695458Gillman MW, Cook NR, Rosner B, Evans DA, Keough ME, Taylor JO, Hennekens CH. Identifying children at high risk for the development of essential hypertension. J Pediatr. 1993 Jun;122(6):837-46. doi: 10.1016/s0022-3476(09)90005-1.
PubMed 8501557
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Tracking--Childhood to Young Adulthood
- ClinicalTrials.gov ID
- NCT00005421
- Acronym / sponsor ID
- 4339
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1992
- Study completion
- Mar 1995 (actual)
- First posted
- 26 May 2000 (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.
To extend analyses of blood pressure (BP) tracking to a period that spanned childhood and young adulthood. Data were used from the same cohort of 339 children who had been followed for nine to twelve years in a previous study.
Detailed description
BACKGROUND:
Blood pressure measurements in childhood and young adulthood are less predictive of future levels than those taken in middle age. In part, this may be due to the fact that within-person variability appears to make up a larger proportion of total variability in childhood than adulthood. Previous work on an NHLBI supported grant indicated that repeated blood pressure measurements and visits led to higher childhood tracking correlations over a period of three years.
DESIGN NARRATIVE:
Follow-up data were used as well as multiple visits which reduced the large within-person variability of blood pressure measurements and improved the tracking correlations. In addition, 'true' or 'corrected' tracking correlations were provided by eliminating the effects of random measurement error. The effects were examined of time-varying covariates on both the observed and true tracking correlations. Besides computing tracking correlations, predictive values were computed for young adult blood pressure given childhood levels. This was the probability that a young adult's true blood pressure was above a specific cutpoint conditional on childhood blood pressure. These values were validated using data from the Fels Longitudinal Study, which included serial blood pressure measurements over the age range in the study. The prediction models were also derived including terms for covariates such as age, sex, height and weight. From these models nomograms were constructed which were useful to physicians for prognostic purposes. Thus, because of the unique multiple-visit approach used in these data, the effect of random measurement error was eliminated. These methodologic improvements strengthened the usefulness of blood pressure screening in childhood to detect those at high risk of developing hypertension.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 16 Mar 2016.
- Background: PubMed 9180649Cook NR, Gillman MW, Rosner BA, Taylor JO, Hennekens CH. Prediction of young adult blood pressure from childhood blood pressure, height, and weight. J Clin Epidemiol. 1997 May;50(5):571-9. doi: 10.1016/s0895-4356(97)00046-2.
- Background: PubMed 8896136Cook NR. Estimating predictive values for blood pressure measurements from multivariate regression models with covariates. Stat Med. 1996 Oct 15;15(19):2013-28. doi: 10.1002/(SICI)1097-0258(19961015)15:193.0.CO;2-Y.
- Background: PubMed 7641339Gillman MW, Cook NR. Blood pressure measurement in childhood epidemiological studies. Circulation. 1995 Aug 15;92(4):1049-57. doi: 10.1161/01.cir.92.4.1049.
- Background: PubMed 7695458Cook NR, Cohen J, Hebert PR, Taylor JO, Hennekens CH. Implications of small reductions in diastolic blood pressure for primary prevention. Arch Intern Med. 1995 Apr 10;155(7):701-9.
- Background: PubMed 8501557Gillman MW, Cook NR, Rosner B, Evans DA, Keough ME, Taylor JO, Hennekens CH. Identifying children at high risk for the development of essential hypertension. J Pediatr. 1993 Jun;122(6):837-46. doi: 10.1016/s0022-3476(09)90005-1.
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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.
Nancy Cook
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005421, which also lists 5 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 16 Mar 2016.