Cardiovascular DiseasesNCT00005476
Sociodemographic Regulation of Cardiovascular Function and Structure
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To establish the aspects of ethnicity that are associated with the differential expression of cardiovascular disease processes in African Americans and Caucasian Americans twin children. 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 1996to Nov 2005
- 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 establish the aspects of ethnicity that are associated with the differential expression of cardiovascular disease processes in African Americans and Caucasian Americans twin children.
Read the detailed description
BACKGROUND:
Given increasing awareness of the extent to which environments typically faced by ethnic groups differ, environmental influence on these processes may be an important factor that is an aspect of ethnicity. Socioeconomic status (SES) is a useful index of such environments and is associated with cardiovascular disease (CVD). Since behavior is one pathway through which SES influences are thought to be expressed in disease, this study focuses specifically on stress responsivity, which is thought to be linked to the pathophysiology of CVD. Since such disease has its antecedents in childhood, a multiethnic pediatric sample is employed. In addition, the subject sample consists of twins. Investigation of the impact of environments on the expression of CVD can be achieved only with proper control for biological influences.
DESIGN NARRATIVE:
Subjects completed three laboratory stressors: a video game task, a structured social interview, and the cold pressor. Stress responsivity was assessed, with particular interest being paid to systemic vascular resistance (SVR). Left ventricular mass (LVM) was also assessed. Sophisticated environmentally and genetically informative analyses permitted quantification of environmental impact upon systemic vascular resistance responsivity and left ventricular mass. It was hypothesized that environmental influences (SES) accounted for a greater proportion of the variance in systemic vascular resistance responsivity and left ventricular mass in African Americans than Caucasian Americans. The hypothesis that systemic vascular resistance responsivity was a pathway through which SES exerted its influence on left ventricular mass was also tested.
The study has been extended through November 2005 to continue examination of the investigator's Twin CV Health cohort (519 pairs of twins who will be 14 to 25 years old). The study provides the unique opportunity to better understand the effects of sodium ion (Na+) retention as a mechanism augmenting systemic vascular resistance responsivity (SVR) and changes in vascular function (i.e., endothelium dependent arterial dilation; EDAD), ventricular structure (i.e., left ventricular mass; LVM) and 24-hour ambulatory BP (ABP). The specific aims are to determine: 1) To what extent is environmental stress related to stress induced Na+ retention, SVR responsivity and preclinical markers of essential hypertension risk and are these relationships stronger in African Americans than Caucasian Americans; 2) Whether stress induced Na+ retention is a pathway linking environmental stress with preclinical markers of essential hypertension risk; and 3) Whether behavioral factors (i.e. John Henryism, anger expression, social support, physical activity) moderate effects of environmental stress on stress induced Na+ retention and/or SVR responsivity and in the preclinical markers of essential hypertension risk, particularly in African Americans.
- 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 1996
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Frank Treiber, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005476
- Sponsor's protocol ID
- 4960
- Other IDs
- R01HL056622
- Status last verified
- May 2009
- First submitted
- 25 May 2000
- Last updated
- 29 Jul 2016
- Results posted
- No
Publications
Jackson RW, Snieder H, Davis H, Treiber FA. Determination of twin zygosity: a comparison of DNA with various questionnaire indices. Twin Res. 2001 Feb;4(1):12-8. doi: 10.1375/1369052012092.
PubMed 11665319Davis CL, Kapuku G, Snieder H, Kumar M, Treiber FA. Insulin resistance syndrome and left ventricular mass in healthy young people. Am J Med Sci. 2002 Aug;324(2):72-5. doi: 10.1097/00000441-200208000-00005.
PubMed 12186110Snieder H, Harshfield GA, Barbeau P, Pollock DM, Pollock JS, Treiber FA. Dissecting the genetic architecture of the cardiovascular and renal stress response. Biol Psychol. 2002 Oct;61(1-2):73-95. doi: 10.1016/s0301-0511(02)00053-4.
PubMed 12385670Barbeau P, Litaker MS, Jackson RW, Treiber FA. A tyrosine hydroxylase microsatellite and hemodynamic response to stress in a multi-ethnic sample of youth. Ethn Dis. 2003 Spring;13(2):186-92.
PubMed 12785414Snieder H, Treiber FA. The Georgia Cardiovascular Twin Study. Twin Res. 2002 Oct;5(5):497-8. doi: 10.1375/136905202320906354.
PubMed 12537884Snieder H, Dong Y, Barbeau P, Harshfield GA, Dalageogou C, Zhu H, Carter ND, Treiber FA. Beta2-adrenergic receptor gene and resting hemodynamics in European and African American youth. Am J Hypertens. 2002 Nov;15(11):973-9. doi: 10.1016/s0895-7061(02)02991-6.
PubMed 12441217Snieder H, Harshfield GA, Treiber FA. Heritability of blood pressure and hemodynamics in African- and European-American youth. Hypertension. 2003 Jun;41(6):1196-201. doi: 10.1161/01.HYP.0000072269.19820.0D. Epub 2003 Apr 28.
PubMed 12719445Wang X, Trivedi R, Treiber F, Snieder H. Genetic and environmental influences on anger expression, John Henryism, and stressful life events: the Georgia Cardiovascular Twin Study. Psychosom Med. 2005 Jan-Feb;67(1):16-23. doi: 10.1097/01.psy.0000146331.10104.d4.
PubMed 15673619Iliadou A, Snieder H, Wang X, Treiber FA, Davis CL. Heritabilities of lipids in young European American and African American twins. Twin Res Hum Genet. 2005 Oct;8(5):492-8. doi: 10.1375/183242705774310187.
PubMed 16212838Imumorin IG, Dong Y, Zhu H, Poole JC, Harshfield GA, Treiber FA, Snieder H. A gene-environment interaction model of stress-induced hypertension. Cardiovasc Toxicol. 2005;5(2):109-32. doi: 10.1385/ct:5:2:109.
PubMed 16046788
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sociodemographic Regulation of Cardiovascular Function and Structure
- ClinicalTrials.gov ID
- NCT00005476
- Acronym / sponsor ID
- 4960
- 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 1996
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (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 establish the aspects of ethnicity that are associated with the differential expression of cardiovascular disease processes in African Americans and Caucasian Americans twin children.
Detailed description
BACKGROUND:
Given increasing awareness of the extent to which environments typically faced by ethnic groups differ, environmental influence on these processes may be an important factor that is an aspect of ethnicity. Socioeconomic status (SES) is a useful index of such environments and is associated with cardiovascular disease (CVD). Since behavior is one pathway through which SES influences are thought to be expressed in disease, this study focuses specifically on stress responsivity, which is thought to be linked to the pathophysiology of CVD. Since such disease has its antecedents in childhood, a multiethnic pediatric sample is employed. In addition, the subject sample consists of twins. Investigation of the impact of environments on the expression of CVD can be achieved only with proper control for biological influences.
DESIGN NARRATIVE:
Subjects completed three laboratory stressors: a video game task, a structured social interview, and the cold pressor. Stress responsivity was assessed, with particular interest being paid to systemic vascular resistance (SVR). Left ventricular mass (LVM) was also assessed. Sophisticated environmentally and genetically informative analyses permitted quantification of environmental impact upon systemic vascular resistance responsivity and left ventricular mass. It was hypothesized that environmental influences (SES) accounted for a greater proportion of the variance in systemic vascular resistance responsivity and left ventricular mass in African Americans than Caucasian Americans. The hypothesis that systemic vascular resistance responsivity was a pathway through which SES exerted its influence on left ventricular mass was also tested.
The study has been extended through November 2005 to continue examination of the investigator's Twin CV Health cohort (519 pairs of twins who will be 14 to 25 years old). The study provides the unique opportunity to better understand the effects of sodium ion (Na+) retention as a mechanism augmenting systemic vascular resistance responsivity (SVR) and changes in vascular function (i.e., endothelium dependent arterial dilation; EDAD), ventricular structure (i.e., left ventricular mass; LVM) and 24-hour ambulatory BP (ABP). The specific aims are to determine: 1) To what extent is environmental stress related to stress induced Na+ retention, SVR responsivity and preclinical markers of essential hypertension risk and are these relationships stronger in African Americans than Caucasian Americans; 2) Whether stress induced Na+ retention is a pathway linking environmental stress with preclinical markers of essential hypertension risk; and 3) Whether behavioral factors (i.e. John Henryism, anger expression, social support, physical activity) moderate effects of environmental stress on stress induced Na+ retention and/or SVR responsivity and in the preclinical markers of essential hypertension risk, particularly in African Americans.
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 29 Jul 2016.
- Background: PubMed 11665319Jackson RW, Snieder H, Davis H, Treiber FA. Determination of twin zygosity: a comparison of DNA with various questionnaire indices. Twin Res. 2001 Feb;4(1):12-8. doi: 10.1375/1369052012092.
- Background: PubMed 12186110Davis CL, Kapuku G, Snieder H, Kumar M, Treiber FA. Insulin resistance syndrome and left ventricular mass in healthy young people. Am J Med Sci. 2002 Aug;324(2):72-5. doi: 10.1097/00000441-200208000-00005.
- Background: PubMed 12385670Snieder H, Harshfield GA, Barbeau P, Pollock DM, Pollock JS, Treiber FA. Dissecting the genetic architecture of the cardiovascular and renal stress response. Biol Psychol. 2002 Oct;61(1-2):73-95. doi: 10.1016/s0301-0511(02)00053-4.
- Background: PubMed 12785414Barbeau P, Litaker MS, Jackson RW, Treiber FA. A tyrosine hydroxylase microsatellite and hemodynamic response to stress in a multi-ethnic sample of youth. Ethn Dis. 2003 Spring;13(2):186-92.
- Background: PubMed 12537884Snieder H, Treiber FA. The Georgia Cardiovascular Twin Study. Twin Res. 2002 Oct;5(5):497-8. doi: 10.1375/136905202320906354.
- Background: PubMed 12441217Snieder H, Dong Y, Barbeau P, Harshfield GA, Dalageogou C, Zhu H, Carter ND, Treiber FA. Beta2-adrenergic receptor gene and resting hemodynamics in European and African American youth. Am J Hypertens. 2002 Nov;15(11):973-9. doi: 10.1016/s0895-7061(02)02991-6.
- Background: PubMed 12719445Snieder H, Harshfield GA, Treiber FA. Heritability of blood pressure and hemodynamics in African- and European-American youth. Hypertension. 2003 Jun;41(6):1196-201. doi: 10.1161/01.HYP.0000072269.19820.0D. Epub 2003 Apr 28.
- Background: PubMed 15673619Wang X, Trivedi R, Treiber F, Snieder H. Genetic and environmental influences on anger expression, John Henryism, and stressful life events: the Georgia Cardiovascular Twin Study. Psychosom Med. 2005 Jan-Feb;67(1):16-23. doi: 10.1097/01.psy.0000146331.10104.d4.
- Background: PubMed 16212838Iliadou A, Snieder H, Wang X, Treiber FA, Davis CL. Heritabilities of lipids in young European American and African American twins. Twin Res Hum Genet. 2005 Oct;8(5):492-8. doi: 10.1375/183242705774310187.
- Background: PubMed 16046788Imumorin IG, Dong Y, Zhu H, Poole JC, Harshfield GA, Treiber FA, Snieder H. A gene-environment interaction model of stress-induced hypertension. Cardiovasc Toxicol. 2005;5(2):109-32. doi: 10.1385/ct:5:2:109.
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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.
Frank Treiber
Augusta University
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 29 Jul 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 NCT00005476, which also lists 10 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 29 Jul 2016.