Cardiovascular DiseasesNCT00005161
Longitudinal Twin Study - Cohort Study of Blood Pressure
An observational study of Cardiovascular Diseases and Heart Diseases, run by Virginia Commonwealth University.
Trial summary
To analyze the genetic and environmental contributions of juvenile hemodynamic determinants of blood pressure, including cardiac output and systemic vascular pressure, to adult cardiovascular risk. 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
- Aug 1983to Jul 1993
- 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 analyze the genetic and environmental contributions of juvenile hemodynamic determinants of blood pressure, including cardiac output and systemic vascular pressure, to adult cardiovascular risk.
Read the detailed description
BACKGROUND:
Identifying individuals at a young age who are at risk for future development of hypertension in adult life is a public health issue of great importance. The imperfect nature of blood pressure tracking throughout childhood and adolescence, and the fact that the genes which determine blood pressure in childhood may not be the same ones which operate in adulthood make it clear that improved predicting models are needed. The twin-parent study design allowed testing more subtle genetic and environmental hypotheses than was possible with nuclear families or twins alone. The longitudinal component permitted an analysis of developmental changes in the genetic expression of the hemodynamic determinants of blood pressure. The inclusion of unlike sex twins permitted an analysis of the consistency of genetic and environmental effects across the sexes.
DESIGN NARRATIVE:
The longitudinal comparison of the cardiovascular responses of adolescent twins and their parents was initialed in 1983. Three cohorts of twin families were enrolled, each cohort beginning 18 months apart. Both monozygotic and dizygotic twins were included. Variables measured included demographics, family history, personality, blood pressure, anthropometry, stage of puberty, dynamic exercise, isometric exercise, psychological stress, echocardiography, genotyping, and lipid profiles. Each cohort revisited every 18 months.
A fourth cohort of 330 preadolescent twin pairs stratified by sex and zygosity was recruited from an established population-based twin registry. The hemodynamic determinants of blood pressure were assessed by non-invasive measurements of cardiac function including echocardiography and response to isometric and dynamic exercise. Zygosity was determined by questionnaire and confirmed by dermatoglyphic analysis and blood group tests. Anthropometric and hemodynamic measurements in the parents were compared to those in the children. The study included up to five sets of longitudinal measurements, thereby permitting an evaluation of whether the same or different genes operated at different ages encompassing pre-puberty, puberty, and post-puberty.
- 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 startAug 1983
- Study completionJul 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)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 Virginia Commonwealth UniversityThe 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
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005161
- Sponsor's protocol ID
- 1033
- Other IDs
- R01HL031010
- Status last verified
- Mar 2016
- First submitted
- 25 May 2000
- Last updated
- 8 Mar 2016
- Results posted
- No
Publications
van den Bree MB, Schieken RM, Moskowitz WB, Eaves LJ. Genetic regulation of hemodynamic variables during dynamic exercise. The MCV twin study. Circulation. 1996 Oct 15;94(8):1864-9. doi: 10.1161/01.cir.94.8.1864.
PubMed 8873661Nance WE. The relevance of twin studies to cardiovascular research. Prog Clin Biol Res. 1984;147:325-48. No abstract available.
PubMed 6377316Schieken RM: Exercise Study of Blood Pressure: A Predictor of Future Hypertension? In: NHLBI Workshop on Juvenile Hypertension, Loggie JHM, Horan M, Gruskin AB, et al (Eds.), Biomedical Information Corporation, NY, NY, 1984
Schieken RM: Children's Blood Pressure. Report of 8th Ross Conference on Pediatric Research, Columbus Ohio: Ross Laboratories, 1985
Corey LA, Eaves LJ, Mellen BG, Nance WE. Testing for developmental changes in gene expression on resemblance for quantitative traits in kinships of twins: application to height, weight, and blood pressure. Genet Epidemiol. 1986;3(2):73-83. doi: 10.1002/gepi.1370030203.
PubMed 3710139Eaves LJ, Long J, Heath AC. A theory of developmental change in quantitative phenotypes applied to cognitive development. Behav Genet. 1986 Jan;16(1):143-62. doi: 10.1007/BF01065484. No abstract available.
PubMed 3707482Schieken RM, Lauer RM, Clarke WR. Hemodynamics in childhood hypertension. Clin Exp Hypertens A. 1986;8(4-5):703-20. doi: 10.3109/10641968609046588.
PubMed 3757286Bodurtha JN, Schieken R, Segrest J, Nance WE. High-density lipoprotein-cholesterol subfractions in adolescent twins. Pediatrics. 1987 Feb;79(2):181-9.
PubMed 3808790Schieken RM. Measurement of left ventricular wall mass in pediatric populations. Hypertension. 1987 Feb;9(2 Pt 2):II47-52. doi: 10.1161/01.hyp.9.2_pt_2.ii47.
PubMed 3804400Martin NG, Clark P, Ofulue AF, Eaves LJ, Corey LA, Nance WE. Does the PI polymorphism alone control alpha-1-antitrypsin expression? Am J Hum Genet. 1987 Mar;40(3):267-77.
PubMed 3495177Hewitt JK, Eaves LJ, Neale MC, Meyer JM. Resolving causes of developmental continuity or "tracking." I. Longitudinal twin studies during growth. Behav Genet. 1988 Mar;18(2):133-51. doi: 10.1007/BF01067836. No abstract available.
PubMed 3377729Schieken RM, Moskowitz WB, Bodurtha J, Mosteller M, Eaves L, Nance W. Aortic stiffness: a new Doppler echocardiographic measure predictive of systolic blood pressure in children. J Am Coll Cardiol. 1988 Jun;11(6):1297-300. doi: 10.1016/0735-1097(88)90295-1.
PubMed 3367005Eaves LJ, Hewitt JK, Heath AC: The Quantitative Study of Human Developmental Change: A Model and its Limitations. 2nd International Conference on Quantitative Genetics, Sinauer Associates, 1988
Schieken RM. Identification of high risk relatives for coronary heart disease. J Am Coll Cardiol. 1988 Oct;12(4):1110-3. doi: 10.1016/0735-1097(88)90487-1.
PubMed 2971084Schieken RM. Preventive cardiology: an overview. J Am Coll Cardiol. 1988 Oct;12(4):1090-1. doi: 10.1016/0735-1097(88)90481-0. No abstract available.
PubMed 3417981
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Twin Study - Cohort Study of Blood Pressure
- ClinicalTrials.gov ID
- NCT00005161
- Acronym / sponsor ID
- 1033
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 1983
- Study completion
- Jul 1993
- 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 analyze the genetic and environmental contributions of juvenile hemodynamic determinants of blood pressure, including cardiac output and systemic vascular pressure, to adult cardiovascular risk.
Detailed description
BACKGROUND:
Identifying individuals at a young age who are at risk for future development of hypertension in adult life is a public health issue of great importance. The imperfect nature of blood pressure tracking throughout childhood and adolescence, and the fact that the genes which determine blood pressure in childhood may not be the same ones which operate in adulthood make it clear that improved predicting models are needed. The twin-parent study design allowed testing more subtle genetic and environmental hypotheses than was possible with nuclear families or twins alone. The longitudinal component permitted an analysis of developmental changes in the genetic expression of the hemodynamic determinants of blood pressure. The inclusion of unlike sex twins permitted an analysis of the consistency of genetic and environmental effects across the sexes.
DESIGN NARRATIVE:
The longitudinal comparison of the cardiovascular responses of adolescent twins and their parents was initialed in 1983. Three cohorts of twin families were enrolled, each cohort beginning 18 months apart. Both monozygotic and dizygotic twins were included. Variables measured included demographics, family history, personality, blood pressure, anthropometry, stage of puberty, dynamic exercise, isometric exercise, psychological stress, echocardiography, genotyping, and lipid profiles. Each cohort revisited every 18 months.
A fourth cohort of 330 preadolescent twin pairs stratified by sex and zygosity was recruited from an established population-based twin registry. The hemodynamic determinants of blood pressure were assessed by non-invasive measurements of cardiac function including echocardiography and response to isometric and dynamic exercise. Zygosity was determined by questionnaire and confirmed by dermatoglyphic analysis and blood group tests. Anthropometric and hemodynamic measurements in the parents were compared to those in the children. The study included up to five sets of longitudinal measurements, thereby permitting an evaluation of whether the same or different genes operated at different ages encompassing pre-puberty, puberty, and post-puberty.
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 8 Mar 2016.
- Background: PubMed 8873661van den Bree MB, Schieken RM, Moskowitz WB, Eaves LJ. Genetic regulation of hemodynamic variables during dynamic exercise. The MCV twin study. Circulation. 1996 Oct 15;94(8):1864-9. doi: 10.1161/01.cir.94.8.1864.
- Background: PubMed 6377316Nance WE. The relevance of twin studies to cardiovascular research. Prog Clin Biol Res. 1984;147:325-48. No abstract available.
- BackgroundSchieken RM: Exercise Study of Blood Pressure: A Predictor of Future Hypertension? In: NHLBI Workshop on Juvenile Hypertension, Loggie JHM, Horan M, Gruskin AB, et al (Eds.), Biomedical Information Corporation, NY, NY, 1984
- BackgroundSchieken RM: Children's Blood Pressure. Report of 8th Ross Conference on Pediatric Research, Columbus Ohio: Ross Laboratories, 1985
- Background: PubMed 3710139Corey LA, Eaves LJ, Mellen BG, Nance WE. Testing for developmental changes in gene expression on resemblance for quantitative traits in kinships of twins: application to height, weight, and blood pressure. Genet Epidemiol. 1986;3(2):73-83. doi: 10.1002/gepi.1370030203.
- Background: PubMed 3707482Eaves LJ, Long J, Heath AC. A theory of developmental change in quantitative phenotypes applied to cognitive development. Behav Genet. 1986 Jan;16(1):143-62. doi: 10.1007/BF01065484. No abstract available.
- Background: PubMed 3757286Schieken RM, Lauer RM, Clarke WR. Hemodynamics in childhood hypertension. Clin Exp Hypertens A. 1986;8(4-5):703-20. doi: 10.3109/10641968609046588.
- Background: PubMed 3808790Bodurtha JN, Schieken R, Segrest J, Nance WE. High-density lipoprotein-cholesterol subfractions in adolescent twins. Pediatrics. 1987 Feb;79(2):181-9.
- Background: PubMed 3804400Schieken RM. Measurement of left ventricular wall mass in pediatric populations. Hypertension. 1987 Feb;9(2 Pt 2):II47-52. doi: 10.1161/01.hyp.9.2_pt_2.ii47.
- Background: PubMed 3495177Martin NG, Clark P, Ofulue AF, Eaves LJ, Corey LA, Nance WE. Does the PI polymorphism alone control alpha-1-antitrypsin expression? Am J Hum Genet. 1987 Mar;40(3):267-77.
- Background: PubMed 3377729Hewitt JK, Eaves LJ, Neale MC, Meyer JM. Resolving causes of developmental continuity or "tracking." I. Longitudinal twin studies during growth. Behav Genet. 1988 Mar;18(2):133-51. doi: 10.1007/BF01067836. No abstract available.
- Background: PubMed 3367005Schieken RM, Moskowitz WB, Bodurtha J, Mosteller M, Eaves L, Nance W. Aortic stiffness: a new Doppler echocardiographic measure predictive of systolic blood pressure in children. J Am Coll Cardiol. 1988 Jun;11(6):1297-300. doi: 10.1016/0735-1097(88)90295-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 8 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 NCT00005161, which also lists 37 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 8 Mar 2016.