Cardiovascular DiseasesNCT00081692
Longitudinal Cardiac Outcomes and Body Composition
An observational study of Cardiovascular Diseases and Heart Diseases, run by Virginia Commonwealth University.
Trial summary
To relate cardiac structure and blood pressure (BP) elevation in adults to childhood BP and body size and composition. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- 715 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Dec 2007
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Echocardiographic measurements were made in 437 male and 492 female adults in the Fels Longitudinal Study who had serial measurements of body composition made and recorded as children. The selection criteria include participants who have at least 10 serial anthropometric visits between 2 and 20 years of age. The anthropometric measurements include weight and height for computation of BMI and blood pressure. Approximately one-half of the sample is 50 years and older.
No eligibility criteria
About this study
To relate cardiac structure and blood pressure (BP) elevation in adults to childhood BP and body size and composition.
Read the detailed description
BACKGROUND:
To describe growth events adequately, long-term serial data with frequent measurements at appropriate ages are necessary. The study uses the Fels Longitudinal Study. In the Fels Longitudinal Study, data collection begins at birth, and all children are scheduled for measurements semiannually, on their birthdays and half birthdays, until the age of 18 years, after which they are scheduled every 2 years. The Fels study is unique with a rich 70-year history of ongoing serial data collection enabling the analysis of relationships of variables collected in childhood to cardiovascular risk factors well into late adulthood.
DESIGN NARRATIVE:
The study will link adult cardiac structure and hemodynamic function with long-term serial childhood data for body size, body composition and blood pressure. To address this goal, 685 adult white active participants in the Fels Longitudinal Study, 352 men and 333 women 20 to 70 years of age, will be studied. These adults were selected based on the availability of serial body size data from 2 to 18 years and serial body composition data from 8 to 18 years. Echo cardiographic data for cardiac structure and hemodynamic parameters will be collected from these 685 adults using well defined procedures with a well established quality control and assurance program. The availability of the long-term childhood records of these Fels participants for body size and composition provides a unique opportunity to relate childhood data to subsequent adult data for cardiac structure and blood pressure. The innovative longitudinal statistical analysis used will include covariates such as age, gender, birth year for secular trend, adulthood lifestyle (smoking, alcohol consumption, and physical activity), adult body size and composition, menopause, and medical condition and medication use. The analysis of the hypotheses in this study links cardiac structure and hemodynamic parameters in adulthood to childhood growth and body composition. Such linkages will reveal how various growth and body composition profiles and patterns during childhood can lead either to pathological or to healthy cardiac structure and hemodynamic parameters in adulthood. Understanding adult cardiac outcomes in response to changes in fat and fat-free mass from childhood into adulthood will provide important clues about potential physiologic mechanisms underlying the observed changes in body mass index (BMI). Elucidating adverse relationships through such a linkage can lead to the early identification of children at high risk for adult cardiovascular disease. This investigation will relate direct measures of body composition to adult cardiac structure and hemodynamic parameters.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Established and validated the echocardiographic protocol that was used to generate the serial data on cardiac structure and function in 723 adults in the FLS population .
Investigators are currently finishing an investigation of racial divergence in cardiac structure, cardiac function and blood pressure in relationship to child growth from 9 to 18 years in 700 women who were participants in the National Growth and Health Study participants. Preliminary results show that women who were overweight during childhood (25 ≤ BMI < 30 kg/m2) had a significantly larger LVM and elevated systolic blood pressure (SBP) at age 22 years than women who were not overweight during childhood. Women who had elevated SBP during childhood had a significantly larger LVM and elevated SBP at age 22 years than women who did not have elevated SBP values during childhood.
Measured: 1929-2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2004 (estimated)
- Study startJan 2004
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 715 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Shumei Sun, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081692
- Sponsor's protocol ID
- 1248
- Other IDs
- R01HL072838-05
- Status last verified
- Aug 2013
- First submitted
- 19 Apr 2004
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sabo RT, Lu Z, Daniels S, Sun SS. Serial childhood BMI and associations with adult hypertension and obesity: the Fels Longitudinal Study. Obesity (Silver Spring). 2012 Aug;20(8):1741-3. doi: 10.1038/oby.2012.58. Epub 2012 Mar 8.
PubMed 22402734Sabo RT, Lu Z, Daniels S, Sun SS. Relationships between serial childhood adiposity measures and adult blood pressure: The Fels longitudinal study. Am J Hum Biol. 2010 Nov-Dec;22(6):830-5. doi: 10.1002/ajhb.21091.
PubMed 20865760
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Cardiac Outcomes and Body Composition
- ClinicalTrials.gov ID
- NCT00081692
- Acronym / sponsor ID
- 1248
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 715 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Apr 2004 (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 relate cardiac structure and blood pressure (BP) elevation in adults to childhood BP and body size and composition.
Detailed description
BACKGROUND:
To describe growth events adequately, long-term serial data with frequent measurements at appropriate ages are necessary. The study uses the Fels Longitudinal Study. In the Fels Longitudinal Study, data collection begins at birth, and all children are scheduled for measurements semiannually, on their birthdays and half birthdays, until the age of 18 years, after which they are scheduled every 2 years. The Fels study is unique with a rich 70-year history of ongoing serial data collection enabling the analysis of relationships of variables collected in childhood to cardiovascular risk factors well into late adulthood.
DESIGN NARRATIVE:
The study will link adult cardiac structure and hemodynamic function with long-term serial childhood data for body size, body composition and blood pressure. To address this goal, 685 adult white active participants in the Fels Longitudinal Study, 352 men and 333 women 20 to 70 years of age, will be studied. These adults were selected based on the availability of serial body size data from 2 to 18 years and serial body composition data from 8 to 18 years. Echo cardiographic data for cardiac structure and hemodynamic parameters will be collected from these 685 adults using well defined procedures with a well established quality control and assurance program. The availability of the long-term childhood records of these Fels participants for body size and composition provides a unique opportunity to relate childhood data to subsequent adult data for cardiac structure and blood pressure. The innovative longitudinal statistical analysis used will include covariates such as age, gender, birth year for secular trend, adulthood lifestyle (smoking, alcohol consumption, and physical activity), adult body size and composition, menopause, and medical condition and medication use. The analysis of the hypotheses in this study links cardiac structure and hemodynamic parameters in adulthood to childhood growth and body composition. Such linkages will reveal how various growth and body composition profiles and patterns during childhood can lead either to pathological or to healthy cardiac structure and hemodynamic parameters in adulthood. Understanding adult cardiac outcomes in response to changes in fat and fat-free mass from childhood into adulthood will provide important clues about potential physiologic mechanisms underlying the observed changes in body mass index (BMI). Elucidating adverse relationships through such a linkage can lead to the early identification of children at high risk for adult cardiovascular disease. This investigation will relate direct measures of body composition to adult cardiac structure and hemodynamic parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Echocardiographic measurements were made in 437 male and 492 female adults in the Fels Longitudinal Study who had serial measurements of body composition made and recorded as children. The selection criteria include participants who have at least 10 serial anthropometric visits between 2 and 20 years of age. The anthropometric measurements include weight and height for computation of BMI and blood pressure. Approximately one-half of the sample is 50 years and older.
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
Established and validated the echocardiographic protocol that was used to generate the serial data on cardiac structure and function in 723 adults in the FLS population .
Time frame: 1929-2009
Investigators are currently finishing an investigation of racial divergence in cardiac structure, cardiac function and blood pressure in relationship to child growth from 9 to 18 years in 700 women who were participants in the National Growth and Health Study participants. Preliminary results show that women who were overweight during childhood (25 ≤ BMI < 30 kg/m2) had a significantly larger LVM and elevated systolic blood pressure (SBP) at age 22 years than women who were not overweight during childhood. Women who had elevated SBP during childhood had a significantly larger LVM and elevated SBP at age 22 years than women who did not have elevated SBP values during childhood.
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 7 Aug 2013.
- Results publication: PubMed 22402734Sabo RT, Lu Z, Daniels S, Sun SS. Serial childhood BMI and associations with adult hypertension and obesity: the Fels Longitudinal Study. Obesity (Silver Spring). 2012 Aug;20(8):1741-3. doi: 10.1038/oby.2012.58. Epub 2012 Mar 8.
- Results publication: PubMed 20865760Sabo RT, Lu Z, Daniels S, Sun SS. Relationships between serial childhood adiposity measures and adult blood pressure: The Fels longitudinal study. Am J Hum Biol. 2010 Nov-Dec;22(6):830-5. doi: 10.1002/ajhb.21091.
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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.
Shumei Sun, PhD principal investigator
Virginia Commonwealth University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by Virginia Commonwealth University.
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 7 Aug 2013. 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.
What does the primary outcome measure?
Established and validated the echocardiographic protocol that was used to generate the serial data on cardiac structure and function in 723 adults in the FLS population . (time frame: 1929-2009). 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 NCT00081692, which also lists 2 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 7 Aug 2013.