Cardiovascular DiseasesNCT00005685
Blood Pressure Control--Racial and Psychosocial Influences
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To examine racial and psychosocial influences on blood pressure control. 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 1983to Jul 2002
- 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 examine racial and psychosocial influences on blood pressure control.
Read the detailed description
BACKGROUND:
Environmental and psychosocial factors relating to hypertension and cardiovascular disease are incompletely understood, particularly for women and African Americans. Recent research has suggested that job strain is more strongly linked to elevated work blood pressure in men than women. In contrast, the combination of having a high status job plus the trait of high effort coping style (John Henryism) was related to higher work blood pressure in women and African American men, but not Caucasian men.
The grant has been ongoing since September 1983. The original study had as its purpose to ascertain similarities and differences in the etiology of hypertension for Blacks and whites and to identify those biobehavioral factors contributing to the excess risk for hypertension among Blacks. Myocardial, blood pressure, and renal responses (sodium and potassium handling) to laboratory and naturalistic stressors were evaluated in young adult normotensive or marginally hypertensive Black and white men. Behavioral stressors included competitive, reaction time tasks (active coping) as well as more passive coping conditions. Data were collected on family history of hypertension, family social class background, Type A behavior, propensity for anger and hostility, and coping style. The role of the sympathetic nervous system in mediating these effects was assessed by the use of beta-adrenergic antagonists.
When the grant was renewed in 1991, the goal of the research was to evaluate the interactive effects of environmental stressors and sodium chloride (NACl) and potassium (K) intake as they related to hypertension development in a biracial population.
DESIGN NARRATIVE:
There were two studies in the current grant. Study 1 reexamined hypothesized relationships of high effort coping and job strain to elevated ambulatory blood pressure (BP) at work and at home in a sample of 288 Black and white men and women stratified by job status. Also, assessments were made of the relationships of these traits to increased epinephrine and norepinephrine responses, other measures of sympathetic activation, adverse lipid profiles, and cardiac and vascular structural changes. Job strain and high effort coping were also related to hypertension prevalence in 576 black and white men and women stratified by job status. The influence of additional psychosocial variables (social support, hostility, anger-in, depressed mood, anxiety) was also examined.
Study 2 built on prior research on gender differences in total peripheral resistance during stressors which enhance alpha-adrenergic activity, and on a recent observation that among young adults, slow sodium excretion during stress is seen in five times as many men as women. It also built on recent work suggesting that estrogen may attenuate total peripheral resistance responses to stress by reducing vasoconstrictive effects of alpha-adrenergic activity. The study was designed to examine cardiovascular, lipid, epinephrine, norepinephrine, and sodium excretion responses to stressors in 120 subjects maintained for a week on a controlled high salt diet. Thirty subjects were tested in each of these groups: 1) premenopausal women, 2) postmenopausal women not using hormone replacement therapy, 3) postmenopausal women using hormone replacement, 4) men. Each group included 15 Black and 15 white subjects, and each subject was tested twice, once after receiving placebo and once after receiving either an alpha- or a beta-receptor antagonist.
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 1983
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)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
- Kathleen Light, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005685
- Sponsor's protocol ID
- 4131
- Other IDs
- R01HL031533
- Status last verified
- Jan 2006
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Girdler SS, Turner JR, Sherwood A, Light KC. Gender differences in blood pressure control during a variety of behavioral stressors. Psychosom Med. 1990 Sep-Oct;52(5):571-91. doi: 10.1097/00006842-199009000-00009.
PubMed 2247562Turner JR, Sherwood A. Postural effects on blood pressure reactivity: implications for studies of laboratory-field generalization. J Psychosom Res. 1991;35(2-3):289-95. doi: 10.1016/0022-3999(91)90083-z.
PubMed 2046061Hinderliter AL, Light KC, Willis PW 4th. Left ventricular mass index and diastolic filling. Relation to blood pressure and demographic variables in a healthy biracial sample. Am J Hypertens. 1991 Jul;4(7 Pt 1):579-85. doi: 10.1093/ajh/4.7.579.
PubMed 1873012Turner JR, Sherwood A, Light KC. Generalization of cardiovascular response: supportive evidence for the reactivity hypothesis. Int J Psychophysiol. 1991 Aug;11(2):207-12. doi: 10.1016/0167-8760(91)90013-n.
PubMed 1748596Hinderliter AL, Light KC, Willis PW 4th. Gender differences in left ventricular structure and function in young adults with normal or marginally elevated blood pressure. Am J Hypertens. 1992 Jan;5(1):32-6. doi: 10.1093/ajh/5.1.32.
PubMed 1736932Light KC, Turner JR. Stress-induced changes in the rate of sodium excretion in healthy black and white men. J Psychosom Res. 1992 Jul;36(5):497-508. doi: 10.1016/0022-3999(92)90011-p.
PubMed 1619590Light KC, Turner JR, Hinderliter AL. Job strain and ambulatory work blood pressure in healthy young men and women. Hypertension. 1992 Aug;20(2):214-8. doi: 10.1161/01.hyp.20.2.214.
PubMed 1639463Sherwood A, Royal SA, Hutcheson JS, Turner JR. Comparison of impedance cardiographic measurements using band and spot electrodes. Psychophysiology. 1992 Nov;29(6):734-41. doi: 10.1111/j.1469-8986.1992.tb02051.x.
PubMed 1461960Light KC, Dolan CA, Davis MR, Sherwood A. Cardiovascular responses to an active coping challenge as predictors of blood pressure patterns 10 to 15 years later. Psychosom Med. 1992 Mar-Apr;54(2):217-30. doi: 10.1097/00006842-199203000-00007.
PubMed 1565757Girdler SS, Hinderliter AL, Light KC. Peripheral adrenergic receptor contributions to cardiovascular reactivity: influence of race and gender. J Psychosom Res. 1993;37(2):177-93. doi: 10.1016/0022-3999(93)90085-t.
PubMed 8385216Sherwood A, Hinderliter AL. Responsiveness to alpha- and beta-adrenergic receptor agonists. Effects of race in borderline hypertensive compared to normotensive men. Am J Hypertens. 1993 Jul;6(7 Pt 1):630-5. doi: 10.1093/ajh/6.7.630.
PubMed 8398005Light KC, Turner JR, Hinderliter AL, Sherwood A. Race and gender comparisons: I. Hemodynamic responses to a series of stressors. Health Psychol. 1993 Sep;12(5):354-65. doi: 10.1037//0278-6133.12.5.354.
PubMed 8223359Light KC, Turner JR, Hinderliter AL, Sherwood A. Race and gender comparisons: II. Predictions of work blood pressure from laboratory baseline and cardiovascular reactivity measures. Health Psychol. 1993 Sep;12(5):366-75. doi: 10.1037//0278-6133.12.5.366.
PubMed 8223360Turner JR, Sherwood A, Light KC. Intertask consistency of hemodynamic responses to laboratory stressors in a biracial sample of men and women. Int J Psychophysiol. 1994 Jul;17(2):159-64. doi: 10.1016/0167-8760(94)90031-0.
PubMed 7995778Hinderliter AL, Light KC, Willis PW 4th. Patients with borderline elevated blood pressure have enhanced left ventricular contractility. Am J Hypertens. 1995 Oct;8(10 Pt 1):1040-5. doi: 10.1016/0895-7061(95)00256-1.
PubMed 8845073
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Control--Racial and Psychosocial Influences
- ClinicalTrials.gov ID
- NCT00005685
- Acronym / sponsor ID
- 4131
- 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 1983
- Study completion
- Jul 2002 (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 examine racial and psychosocial influences on blood pressure control.
Detailed description
BACKGROUND:
Environmental and psychosocial factors relating to hypertension and cardiovascular disease are incompletely understood, particularly for women and African Americans. Recent research has suggested that job strain is more strongly linked to elevated work blood pressure in men than women. In contrast, the combination of having a high status job plus the trait of high effort coping style (John Henryism) was related to higher work blood pressure in women and African American men, but not Caucasian men.
The grant has been ongoing since September 1983. The original study had as its purpose to ascertain similarities and differences in the etiology of hypertension for Blacks and whites and to identify those biobehavioral factors contributing to the excess risk for hypertension among Blacks. Myocardial, blood pressure, and renal responses (sodium and potassium handling) to laboratory and naturalistic stressors were evaluated in young adult normotensive or marginally hypertensive Black and white men. Behavioral stressors included competitive, reaction time tasks (active coping) as well as more passive coping conditions. Data were collected on family history of hypertension, family social class background, Type A behavior, propensity for anger and hostility, and coping style. The role of the sympathetic nervous system in mediating these effects was assessed by the use of beta-adrenergic antagonists.
When the grant was renewed in 1991, the goal of the research was to evaluate the interactive effects of environmental stressors and sodium chloride (NACl) and potassium (K) intake as they related to hypertension development in a biracial population.
DESIGN NARRATIVE:
There were two studies in the current grant. Study 1 reexamined hypothesized relationships of high effort coping and job strain to elevated ambulatory blood pressure (BP) at work and at home in a sample of 288 Black and white men and women stratified by job status. Also, assessments were made of the relationships of these traits to increased epinephrine and norepinephrine responses, other measures of sympathetic activation, adverse lipid profiles, and cardiac and vascular structural changes. Job strain and high effort coping were also related to hypertension prevalence in 576 black and white men and women stratified by job status. The influence of additional psychosocial variables (social support, hostility, anger-in, depressed mood, anxiety) was also examined.
Study 2 built on prior research on gender differences in total peripheral resistance during stressors which enhance alpha-adrenergic activity, and on a recent observation that among young adults, slow sodium excretion during stress is seen in five times as many men as women. It also built on recent work suggesting that estrogen may attenuate total peripheral resistance responses to stress by reducing vasoconstrictive effects of alpha-adrenergic activity. The study was designed to examine cardiovascular, lipid, epinephrine, norepinephrine, and sodium excretion responses to stressors in 120 subjects maintained for a week on a controlled high salt diet. Thirty subjects were tested in each of these groups: 1) premenopausal women, 2) postmenopausal women not using hormone replacement therapy, 3) postmenopausal women using hormone replacement, 4) men. Each group included 15 Black and 15 white subjects, and each subject was tested twice, once after receiving placebo and once after receiving either an alpha- or a beta-receptor antagonist.
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 13 May 2016.
- Background: PubMed 2247562Girdler SS, Turner JR, Sherwood A, Light KC. Gender differences in blood pressure control during a variety of behavioral stressors. Psychosom Med. 1990 Sep-Oct;52(5):571-91. doi: 10.1097/00006842-199009000-00009.
- Background: PubMed 2046061Turner JR, Sherwood A. Postural effects on blood pressure reactivity: implications for studies of laboratory-field generalization. J Psychosom Res. 1991;35(2-3):289-95. doi: 10.1016/0022-3999(91)90083-z.
- Background: PubMed 1873012Hinderliter AL, Light KC, Willis PW 4th. Left ventricular mass index and diastolic filling. Relation to blood pressure and demographic variables in a healthy biracial sample. Am J Hypertens. 1991 Jul;4(7 Pt 1):579-85. doi: 10.1093/ajh/4.7.579.
- Background: PubMed 1748596Turner JR, Sherwood A, Light KC. Generalization of cardiovascular response: supportive evidence for the reactivity hypothesis. Int J Psychophysiol. 1991 Aug;11(2):207-12. doi: 10.1016/0167-8760(91)90013-n.
- Background: PubMed 1736932Hinderliter AL, Light KC, Willis PW 4th. Gender differences in left ventricular structure and function in young adults with normal or marginally elevated blood pressure. Am J Hypertens. 1992 Jan;5(1):32-6. doi: 10.1093/ajh/5.1.32.
- Background: PubMed 1619590Light KC, Turner JR. Stress-induced changes in the rate of sodium excretion in healthy black and white men. J Psychosom Res. 1992 Jul;36(5):497-508. doi: 10.1016/0022-3999(92)90011-p.
- Background: PubMed 1639463Light KC, Turner JR, Hinderliter AL. Job strain and ambulatory work blood pressure in healthy young men and women. Hypertension. 1992 Aug;20(2):214-8. doi: 10.1161/01.hyp.20.2.214.
- Background: PubMed 1461960Sherwood A, Royal SA, Hutcheson JS, Turner JR. Comparison of impedance cardiographic measurements using band and spot electrodes. Psychophysiology. 1992 Nov;29(6):734-41. doi: 10.1111/j.1469-8986.1992.tb02051.x.
- Background: PubMed 1565757Light KC, Dolan CA, Davis MR, Sherwood A. Cardiovascular responses to an active coping challenge as predictors of blood pressure patterns 10 to 15 years later. Psychosom Med. 1992 Mar-Apr;54(2):217-30. doi: 10.1097/00006842-199203000-00007.
- Background: PubMed 8385216Girdler SS, Hinderliter AL, Light KC. Peripheral adrenergic receptor contributions to cardiovascular reactivity: influence of race and gender. J Psychosom Res. 1993;37(2):177-93. doi: 10.1016/0022-3999(93)90085-t.
- Background: PubMed 8398005Sherwood A, Hinderliter AL. Responsiveness to alpha- and beta-adrenergic receptor agonists. Effects of race in borderline hypertensive compared to normotensive men. Am J Hypertens. 1993 Jul;6(7 Pt 1):630-5. doi: 10.1093/ajh/6.7.630.
- Background: PubMed 8223359Light KC, Turner JR, Hinderliter AL, Sherwood A. Race and gender comparisons: I. Hemodynamic responses to a series of stressors. Health Psychol. 1993 Sep;12(5):354-65. doi: 10.1037//0278-6133.12.5.354.
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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.
Kathleen Light
University of North Carolina
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 13 May 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 NCT00005685, which also lists 26 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 13 May 2016.