Cardiovascular DiseasesNCT00005200
Adolescent Blood Pressure Variation and Ventricular Mass
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To evaluate possible early neurogenic influence in essential hypertension by monitoring heart growth in adolescents over a two year interval. 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
- Jul 1987to Jun 1991
- 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 evaluate possible early neurogenic influence in essential hypertension by monitoring heart growth in adolescents over a two year interval.
Read the detailed description
BACKGROUND:
Evidence has accumulated suggesting that essential hypertension begins early in life and is potentially preventable. One possible pathogenetic mechanism implicated is a sympathetic nervous system abnormality which is manifested by increased sympathetic drive to the heart. An elevated sympathetic nervous system tone and decreased vagal inhibition is responsible for the hyperkinetic circulation seen in a significant proportion of persons with borderline essential hypertension. Exaggerated blood pressure and heart rate responses to mental stressors have been documented in normotensive children of hypertensive parents. These changes appear to involve sympathetic over-responding to fight-flight stimuli.
Increased blood pressure variability induced by stress might accelerate vascular and other changes leading to essential hypertension. Behavior and environment might chronically elevate sympathetic nervous system tone with damaging cardiovascular consequences. Stressful working conditions, defective anger management and poor interpersonal problem solving skills have been implicated in studies of stress-induced blood pressure increases. These influences may interact with diet and genetic risk to exacerbate pathophysiology. Essential hypertension risk might be reduced by modifying working and living environments and by training young persons at risk to cope with or avoid stressors that elicit defensive over-responding.
DESIGN NARRATIVE:
This longitudinal study tested two different models of sympathetic nervous system influence on the early pathophysiology of essential hypertension. The first neurogenic model was evaluated by determining whether an excessively variable or reactive blood pressure in year 1 gave rise to excessive heart growth or left ventricular hypertrophy over a two year follow-up. The second neurogenic model was evaluated by determining if higher blood pressure exacerbated by personality, stress, and dietary sodium intake led to increased left ventricular hypertrophy at follow-up.
All ninth-graders entering two large Baltimore high schools in year 1 and year 2 of the study were screened to yield the 240 subjects in the cohort. Initial screening included data on blood pressure, height, weight, health habits, personality, medical history, and health care utilization. Baseline exam included data on basal blood pressure, aerobic exercise stress, cognitive stress, interpersonal stress, ambulatory blood pressure, echocardiogram, physical activity, and Type A personality. The parents were also interviewed to assess family blood pressure status, health history, health care utilization and dietary habits including sodium intake. Students were re-examined at twelve and 24 months.
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 startJul 1987
- Study completionJun 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005200
- Sponsor's protocol ID
- 1079
- Other IDs
- R01HL036298
- Status last verified
- Apr 2000
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Ewart CK. Psychological effects of resistive weight training: implications for cardiac patients. Med Sci Sports Exerc. 1989 Dec;21(6):683-8. doi: 10.1249/00005768-198912000-00011.
PubMed 2696855Ewart CK, Kolodner KB. Negative affect, gender, and expressive style predict elevated ambulatory blood pressure in adolescents. J Pers Soc Psychol. 1994 Mar;66(3):596-605. doi: 10.1037//0022-3514.66.3.596.
PubMed 8169768Ewart CK, Kolodner KB. Diminished pulse pressure response to psychological stress: early precursor of essential hypertension? Psychosom Med. 1992 Jul-Aug;54(4):436-46. doi: 10.1097/00006842-199207000-00006.
PubMed 1502285Ewart CK. Social action theory for a public health psychology. Am Psychol. 1991 Sep;46(9):931-46. doi: 10.1037//0003-066x.46.9.931.
PubMed 1958012Ewart CK, Kolodner KB. Social competence interview for assessing physiological reactivity in adolescents. Psychosom Med. 1991 May-Jun;53(3):289-304. doi: 10.1097/00006842-199105000-00003.
PubMed 1882010Ewart CK, Taylor CB, Kraemer HC, Agras WS. High blood pressure and marital discord: not being nasty matters more than being nice. Health Psychol. 1991;10(3):155-63. doi: 10.1037//0278-6133.10.3.155.
PubMed 1879387Hanna KJ, Ewart CK, Kwiterovich PO Jr. Child problem solving competence, behavioral adjustment and adherence to lipid-lowering diet. Patient Educ Couns. 1990 Oct;16(2):119-31. doi: 10.1016/0738-3991(90)90086-z.
PubMed 2290766Ewart CK, Kolodner KB. Predicting ambulatory blood pressure during school: effectiveness of social and nonsocial reactivity tasks in black and white adolescents. Psychophysiology. 1993 Jan;30(1):30-8. doi: 10.1111/j.1469-8986.1993.tb03202.x.
PubMed 8416060
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Blood Pressure Variation and Ventricular Mass
- ClinicalTrials.gov ID
- NCT00005200
- Acronym / sponsor ID
- 1079
- 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
- Jul 1987
- Study completion
- Jun 1991 (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 evaluate possible early neurogenic influence in essential hypertension by monitoring heart growth in adolescents over a two year interval.
Detailed description
BACKGROUND:
Evidence has accumulated suggesting that essential hypertension begins early in life and is potentially preventable. One possible pathogenetic mechanism implicated is a sympathetic nervous system abnormality which is manifested by increased sympathetic drive to the heart. An elevated sympathetic nervous system tone and decreased vagal inhibition is responsible for the hyperkinetic circulation seen in a significant proportion of persons with borderline essential hypertension. Exaggerated blood pressure and heart rate responses to mental stressors have been documented in normotensive children of hypertensive parents. These changes appear to involve sympathetic over-responding to fight-flight stimuli.
Increased blood pressure variability induced by stress might accelerate vascular and other changes leading to essential hypertension. Behavior and environment might chronically elevate sympathetic nervous system tone with damaging cardiovascular consequences. Stressful working conditions, defective anger management and poor interpersonal problem solving skills have been implicated in studies of stress-induced blood pressure increases. These influences may interact with diet and genetic risk to exacerbate pathophysiology. Essential hypertension risk might be reduced by modifying working and living environments and by training young persons at risk to cope with or avoid stressors that elicit defensive over-responding.
DESIGN NARRATIVE:
This longitudinal study tested two different models of sympathetic nervous system influence on the early pathophysiology of essential hypertension. The first neurogenic model was evaluated by determining whether an excessively variable or reactive blood pressure in year 1 gave rise to excessive heart growth or left ventricular hypertrophy over a two year follow-up. The second neurogenic model was evaluated by determining if higher blood pressure exacerbated by personality, stress, and dietary sodium intake led to increased left ventricular hypertrophy at follow-up.
All ninth-graders entering two large Baltimore high schools in year 1 and year 2 of the study were screened to yield the 240 subjects in the cohort. Initial screening included data on blood pressure, height, weight, health habits, personality, medical history, and health care utilization. Baseline exam included data on basal blood pressure, aerobic exercise stress, cognitive stress, interpersonal stress, ambulatory blood pressure, echocardiogram, physical activity, and Type A personality. The parents were also interviewed to assess family blood pressure status, health history, health care utilization and dietary habits including sodium intake. Students were re-examined at twelve and 24 months.
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 18 Feb 2016.
- Background: PubMed 2696855Ewart CK. Psychological effects of resistive weight training: implications for cardiac patients. Med Sci Sports Exerc. 1989 Dec;21(6):683-8. doi: 10.1249/00005768-198912000-00011.
- Background: PubMed 8169768Ewart CK, Kolodner KB. Negative affect, gender, and expressive style predict elevated ambulatory blood pressure in adolescents. J Pers Soc Psychol. 1994 Mar;66(3):596-605. doi: 10.1037//0022-3514.66.3.596.
- Background: PubMed 1502285Ewart CK, Kolodner KB. Diminished pulse pressure response to psychological stress: early precursor of essential hypertension? Psychosom Med. 1992 Jul-Aug;54(4):436-46. doi: 10.1097/00006842-199207000-00006.
- Background: PubMed 1958012Ewart CK. Social action theory for a public health psychology. Am Psychol. 1991 Sep;46(9):931-46. doi: 10.1037//0003-066x.46.9.931.
- Background: PubMed 1882010Ewart CK, Kolodner KB. Social competence interview for assessing physiological reactivity in adolescents. Psychosom Med. 1991 May-Jun;53(3):289-304. doi: 10.1097/00006842-199105000-00003.
- Background: PubMed 1879387Ewart CK, Taylor CB, Kraemer HC, Agras WS. High blood pressure and marital discord: not being nasty matters more than being nice. Health Psychol. 1991;10(3):155-63. doi: 10.1037//0278-6133.10.3.155.
- Background: PubMed 2290766Hanna KJ, Ewart CK, Kwiterovich PO Jr. Child problem solving competence, behavioral adjustment and adherence to lipid-lowering diet. Patient Educ Couns. 1990 Oct;16(2):119-31. doi: 10.1016/0738-3991(90)90086-z.
- Background: PubMed 8416060Ewart CK, Kolodner KB. Predicting ambulatory blood pressure during school: effectiveness of social and nonsocial reactivity tasks in black and white adolescents. Psychophysiology. 1993 Jan;30(1):30-8. doi: 10.1111/j.1469-8986.1993.tb03202.x.
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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 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 18 Feb 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 NCT00005200, which also lists 8 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 18 Feb 2016.