Cardiovascular DiseasesNCT00005170
Ambulatory Blood Pressure and Behavior
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine ways in which behavioral factors influenced the diagnosis and development of hypertension in adult working populations. 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
- Dec 1984to Feb 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 determine ways in which behavioral factors influenced the diagnosis and development of hypertension in adult working populations.
Read the detailed description
BACKGROUND:
The causes of essential hypertension remain unknown, but it is generally agreed that both genetic and environmental factors are important. Of the latter, the two leading contenders are nutrition including sodium intake and weight gain, and psychosocial stress. It is probable that no single factor is responsible, and that hypertension is most likely to develop when a number of factors act in unison, so that different mechanisms operate in different individuals. It also seems probable that there may be two different components to the development of hypertension, with differing time courses. First, there are a number of mechanisms which produce rapid changes of blood pressure, which are not necessarily sustained for very long. Prime among these are the sympathetic nervous system and the renin-angiotensin system. Although derangements of both have been described in patients with essential hypertension, neither can on its own explain the overall mechanism. Secondly, there is also a slowly occurring hypertrophy of the arterial wall, which occurs partly in response to the transient increases of pressure, but also acts as a positive feedback loop, serving to amplify them. It seems probable that a number of different mechanisms may be involved in the first process, possibly including the effects of psychosocial stress and nutrition, but that the slow mechanism may be the final common path which maintains and amplifies the development of hypertension independently of the initiating causes. While the relevance of behavioral factors, or stress in hypertension is commonly accepted by the lay public, it has found much less acceptance among their physicians. This is perhaps not surprising, because stress is so hard to quantify on a scientific basis, particularly when it is borne in mind that there is still no agreement about the role of sodium intake, which is comparatively easy to quantify, in the development of hypertension. The treatment of patients with mild hypertension is a major public health issue. There are two possible strategies to counter the costs and side effects of universal pharmacological treatment, namely, defining high risk patients and finding safer methods of treatment. Patients with white coat hypertension show elevations of blood pressure only in the clinic situation. If it can be demonstrated that individuals with white coat hypertension are not at increased risk and do not exhibit the physiological and biochemical characteristics normally associated with early hypertension, such individuals will not necessarily require drug treatment but may be treated by desensitization. Also, the studies on job strain may enable identification of some environmental risk factors which may have an adverse effect on certain individuals' blood pressure. If job strain does influence blood pressure, it presents the possibility of an entirely new non-pharmacological method of preventing or treating hypertension, through manipulation of the work environment.
DESIGN NARRATIVE:
When the study was initiated in 1984, five interdisciplinary studies were conducted. Study 1 followed 1,500 hypertensive patients who had ambulatory blood pressures recorded over the last ten years, to determine whether ambulatory blood pressure improved the prediction of morbid events relative to clinic blood pressures. Study 2 evaluated factors contributing to white coat hypertension, and whether it could be treated behaviorally. Study 3 compared the reactivity to beta-adrenergic stimulation and to behavioral tasks in normals and patients with hypertension or depression. Study 4 tested the Job Strain Model in the laboratory by investigating the interactive effects on blood pressure of varying levels of workload or task difficulty and decision latitude or degree of personal control during a challenging behavioral task. Generalization of this measure of reactivity was assessed by comparison with ambulatory blood pressure recordings. Study 5, in a cohort study of 400 subjects, determined whether individuals in high-strain jobs showed greater elevations of blood pressure over five years than those in low-strain jobs.
The study was renewed for one year in 1993 as a continuation and extension of the study of the association between occupational stress ('job strain', evaluated by the Karasek Job Content Survey) and hypertensive cardiovascular disease, evaluated principally by ambulatory blood pressure (ABP) and left ventricular mass index (LVMI). It was originally a case control study in which cases (hypertensive subjects) were found to be more likely to be exposed to job strain than normotensive controls, with an odds ratio of 2.75, and to have a greater LVMI. This effect was independent of other known risk factors for hypertension. It was extended as a prospective study of 314 men and women studied at 9 worksites during Waves of observation over five years. Preliminary results from Waves 1 and 2 showed a longitudinal association between persistent job strain and progressive elevation of ABP.
In the renewal, the investigators increased the sample size by 100 subjects and added a 4th Wave of observation. In Wave 3, they added a new outcome measure-ultrasound examination of the carotid artery, which detected early structural changes and atherosclerosis. They also monitored physical activity continuously during ABP monitoring using an Actigraph monitor. A new focus wass on social support, which had been shown to relate to cardiovascular morbidity, possibly via an interaction effect with job strain. The investigators evaluated how its availability and perceived satisfaction interacted with job strain and their outcome measures. The effects of job strain on urinary catecholamines and cortisol were also examined in 210 subjects, to test the hypothesis that job strain was associated with an overactivity of both the sympathetic nervous system and adrenocortical system, by analogy with Frankenhaueser's Effort-Distress model. In Wave 4 they also performed reactivity testing, in order to examine correlations between reactivity, atherosclerosis, and other cardiovascular variables. The research helped to determine whether sequential linkages existed between major psychosocial factors (job strain and lack of social support), mechanisms mediating cardiovascular damage (elevated ABP and sympathoadrenal activation), and resultant preclinical cardiovascular disease (left ventricular hypertrophy and carotid atherosclerosis).
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 startDec 1984
- Study completionFeb 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (57)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
- NCT00005170
- Sponsor's protocol ID
- 1044
- Other IDs
- R01HL030605
- Status last verified
- Apr 2000
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Roman MJ, Pickering TG, Schwartz JE, Cavallini MC, Pini R, Devereux RB. Is the absence of a normal nocturnal fall in blood pressure (nondipping) associated with cardiovascular target organ damage? J Hypertens. 1997 Sep;15(9):969-78. doi: 10.1097/00004872-199715090-00007.
PubMed 9321744Kleinert HD, Harshfield GA, Pickering TG, Devereux RB, Sullivan PA, Marion RM, Mallory WK, Laragh JH. What is the value of home blood pressure measurement in patients with mild hypertension? Hypertension. 1984 Jul-Aug;6(4):574-8. doi: 10.1161/01.hyp.6.4.574.
PubMed 6235190Wallace JM, Thornton WE, Kennedy HL, Pickering TG, Harshfield GA, Frohlich ED, Gifford RW, Bolen K: Ambulatory Blood Pressure in 199 Normal Subjects. A Collaborative Study. In: Ambulatory Blood Pressure Monitoring, Weber MA, Drayer JIM (Eds). Steinkopff-Verlag. Darmstadt, pp. 117-127, 1984
Pickering TG, Harshfield GA, Devereux RB: Ambulatory Monitoring of Blood Pressure: The Importance of Blood Pressure During Work. In: Ambulatory Blood Pressure Monitoring. Weber MA, Drayer JIM (Eds), Steinkopff-Verlag. Darmstadt, pp. 193-197, 1984
Harshfield GA, Pickering TG, Blank S, Lindahl C, Stroud L, Laragh JH: Ambulatory Blood Pressure Monitoring: Records, Applications, and Analysis. In: Ambulatory Blood Pressure Monitoring. Weber MA, Drayer JIM (Eds). Steinkopff-Verlag. Darmstadt, pp. 1-7, 1984
Schneiderman N, Pickering T: Hemodyamic and Electrophysiological Measures of Reactivity. In: Stress, Reactivity, and Cardiovascular Disease. Proceedings of the Working Conference. U.S. Department of Health and Human Services. NIH Publication No. 84-2698, p. 85-106, 1984
Pickering TG, Harshfield GA, Devereux RB, Laragh JH. What is the role of ambulatory blood pressure monitoring in the management of hypertensive patients? Hypertension. 1985 Mar-Apr;7(2):171-7. doi: 10.1161/01.hyp.7.2.171.
PubMed 3156813Thailer SA, Friedman R, Harshfield GA, Pickering TG. Psychologic differences between high-, normal-, and low-renin hypertensives. Psychosom Med. 1985 May-Jun;47(3):294-7. doi: 10.1097/00006842-198505000-00007.
PubMed 3889967Pickering TG, Harshfield GA, Laragh JH. Ambulatory versus casual blood pressure in the diagnosis of hypertensive patients. Clin Exp Hypertens A. 1985;7(2-3):257-66. doi: 10.3109/10641968509073545. No abstract available.
PubMed 3891153Harshfield GA, Pickering TG, Blank S, Laragh JH: How Well do Casual Blood Pressures Reflect Ambulatory Blood Pressure? In: Blood Pressure Recording in the Clinical Management of Hypertension. Giuseppe G (Ed). Edizioni L, Pozzi, pp. 50-54, 1985
Lutas EM, Devereux RB, Reis G, Alderman MH, Pickering TG, Borer JS, Laragh JH. Increased cardiac performance in mild essential hypertension. Left ventricular mechanics. Hypertension. 1985 Nov-Dec;7(6 Pt 1):979-88. doi: 10.1161/01.hyp.7.6.979.
PubMed 2934328Schneiderman N, Pickering TG: Cardiovascular Measures of Physiologic Reactivity. In: Handbook of Stress, Reactivity, & Cardiovascular Disease. Matthews KA, Weiss SM, Detre T, Dembroski TM, Falkner B, Manuck SB, Williams RB, Jr. (Eds). John Wiley & Sons, Inc, New York, pp. 145-186, 1986
Casale PN, Devereux RB, Milner M, Zullo G, Harshfield GA, Pickering TG, Laragh JH. Value of echocardiographic measurement of left ventricular mass in predicting cardiovascular morbid events in hypertensive men. Ann Intern Med. 1986 Aug;105(2):173-8. doi: 10.7326/0003-4819-105-2-173.
PubMed 2942070Pickering TG, Harshfield GA, Blank S, James GD, Laragh JH, Clark L, Denby L, Pregibon D. Behavioral determinants of 24-hour blood pressure patterns in borderline hypertension. J Cardiovasc Pharmacol. 1986;8 Suppl 5:S89-92. doi: 10.1097/00005344-198608005-00017.
PubMed 2427893James GD, Yee LS, Harshfield GA, Blank SG, Pickering TG. The influence of happiness, anger, and anxiety on the blood pressure of borderline hypertensives. Psychosom Med. 1986 Sep-Oct;48(7):502-8. doi: 10.1097/00006842-198609000-00005.
PubMed 3763789
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
- Ambulatory Blood Pressure and Behavior
- ClinicalTrials.gov ID
- NCT00005170
- Acronym / sponsor ID
- 1044
- 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
- Dec 1984
- Study completion
- Feb 1993 (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 determine ways in which behavioral factors influenced the diagnosis and development of hypertension in adult working populations.
Detailed description
BACKGROUND:
The causes of essential hypertension remain unknown, but it is generally agreed that both genetic and environmental factors are important. Of the latter, the two leading contenders are nutrition including sodium intake and weight gain, and psychosocial stress. It is probable that no single factor is responsible, and that hypertension is most likely to develop when a number of factors act in unison, so that different mechanisms operate in different individuals. It also seems probable that there may be two different components to the development of hypertension, with differing time courses. First, there are a number of mechanisms which produce rapid changes of blood pressure, which are not necessarily sustained for very long. Prime among these are the sympathetic nervous system and the renin-angiotensin system. Although derangements of both have been described in patients with essential hypertension, neither can on its own explain the overall mechanism. Secondly, there is also a slowly occurring hypertrophy of the arterial wall, which occurs partly in response to the transient increases of pressure, but also acts as a positive feedback loop, serving to amplify them. It seems probable that a number of different mechanisms may be involved in the first process, possibly including the effects of psychosocial stress and nutrition, but that the slow mechanism may be the final common path which maintains and amplifies the development of hypertension independently of the initiating causes. While the relevance of behavioral factors, or stress in hypertension is commonly accepted by the lay public, it has found much less acceptance among their physicians. This is perhaps not surprising, because stress is so hard to quantify on a scientific basis, particularly when it is borne in mind that there is still no agreement about the role of sodium intake, which is comparatively easy to quantify, in the development of hypertension. The treatment of patients with mild hypertension is a major public health issue. There are two possible strategies to counter the costs and side effects of universal pharmacological treatment, namely, defining high risk patients and finding safer methods of treatment. Patients with white coat hypertension show elevations of blood pressure only in the clinic situation. If it can be demonstrated that individuals with white coat hypertension are not at increased risk and do not exhibit the physiological and biochemical characteristics normally associated with early hypertension, such individuals will not necessarily require drug treatment but may be treated by desensitization. Also, the studies on job strain may enable identification of some environmental risk factors which may have an adverse effect on certain individuals' blood pressure. If job strain does influence blood pressure, it presents the possibility of an entirely new non-pharmacological method of preventing or treating hypertension, through manipulation of the work environment.
DESIGN NARRATIVE:
When the study was initiated in 1984, five interdisciplinary studies were conducted. Study 1 followed 1,500 hypertensive patients who had ambulatory blood pressures recorded over the last ten years, to determine whether ambulatory blood pressure improved the prediction of morbid events relative to clinic blood pressures. Study 2 evaluated factors contributing to white coat hypertension, and whether it could be treated behaviorally. Study 3 compared the reactivity to beta-adrenergic stimulation and to behavioral tasks in normals and patients with hypertension or depression. Study 4 tested the Job Strain Model in the laboratory by investigating the interactive effects on blood pressure of varying levels of workload or task difficulty and decision latitude or degree of personal control during a challenging behavioral task. Generalization of this measure of reactivity was assessed by comparison with ambulatory blood pressure recordings. Study 5, in a cohort study of 400 subjects, determined whether individuals in high-strain jobs showed greater elevations of blood pressure over five years than those in low-strain jobs.
The study was renewed for one year in 1993 as a continuation and extension of the study of the association between occupational stress ('job strain', evaluated by the Karasek Job Content Survey) and hypertensive cardiovascular disease, evaluated principally by ambulatory blood pressure (ABP) and left ventricular mass index (LVMI). It was originally a case control study in which cases (hypertensive subjects) were found to be more likely to be exposed to job strain than normotensive controls, with an odds ratio of 2.75, and to have a greater LVMI. This effect was independent of other known risk factors for hypertension. It was extended as a prospective study of 314 men and women studied at 9 worksites during Waves of observation over five years. Preliminary results from Waves 1 and 2 showed a longitudinal association between persistent job strain and progressive elevation of ABP.
In the renewal, the investigators increased the sample size by 100 subjects and added a 4th Wave of observation. In Wave 3, they added a new outcome measure-ultrasound examination of the carotid artery, which detected early structural changes and atherosclerosis. They also monitored physical activity continuously during ABP monitoring using an Actigraph monitor. A new focus wass on social support, which had been shown to relate to cardiovascular morbidity, possibly via an interaction effect with job strain. The investigators evaluated how its availability and perceived satisfaction interacted with job strain and their outcome measures. The effects of job strain on urinary catecholamines and cortisol were also examined in 210 subjects, to test the hypothesis that job strain was associated with an overactivity of both the sympathetic nervous system and adrenocortical system, by analogy with Frankenhaueser's Effort-Distress model. In Wave 4 they also performed reactivity testing, in order to examine correlations between reactivity, atherosclerosis, and other cardiovascular variables. The research helped to determine whether sequential linkages existed between major psychosocial factors (job strain and lack of social support), mechanisms mediating cardiovascular damage (elevated ABP and sympathoadrenal activation), and resultant preclinical cardiovascular disease (left ventricular hypertrophy and carotid atherosclerosis).
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 9321744Roman MJ, Pickering TG, Schwartz JE, Cavallini MC, Pini R, Devereux RB. Is the absence of a normal nocturnal fall in blood pressure (nondipping) associated with cardiovascular target organ damage? J Hypertens. 1997 Sep;15(9):969-78. doi: 10.1097/00004872-199715090-00007.
- Background: PubMed 6235190Kleinert HD, Harshfield GA, Pickering TG, Devereux RB, Sullivan PA, Marion RM, Mallory WK, Laragh JH. What is the value of home blood pressure measurement in patients with mild hypertension? Hypertension. 1984 Jul-Aug;6(4):574-8. doi: 10.1161/01.hyp.6.4.574.
- BackgroundWallace JM, Thornton WE, Kennedy HL, Pickering TG, Harshfield GA, Frohlich ED, Gifford RW, Bolen K: Ambulatory Blood Pressure in 199 Normal Subjects. A Collaborative Study. In: Ambulatory Blood Pressure Monitoring, Weber MA, Drayer JIM (Eds). Steinkopff-Verlag. Darmstadt, pp. 117-127, 1984
- BackgroundPickering TG, Harshfield GA, Devereux RB: Ambulatory Monitoring of Blood Pressure: The Importance of Blood Pressure During Work. In: Ambulatory Blood Pressure Monitoring. Weber MA, Drayer JIM (Eds), Steinkopff-Verlag. Darmstadt, pp. 193-197, 1984
- BackgroundHarshfield GA, Pickering TG, Blank S, Lindahl C, Stroud L, Laragh JH: Ambulatory Blood Pressure Monitoring: Records, Applications, and Analysis. In: Ambulatory Blood Pressure Monitoring. Weber MA, Drayer JIM (Eds). Steinkopff-Verlag. Darmstadt, pp. 1-7, 1984
- BackgroundSchneiderman N, Pickering T: Hemodyamic and Electrophysiological Measures of Reactivity. In: Stress, Reactivity, and Cardiovascular Disease. Proceedings of the Working Conference. U.S. Department of Health and Human Services. NIH Publication No. 84-2698, p. 85-106, 1984
- Background: PubMed 3156813Pickering TG, Harshfield GA, Devereux RB, Laragh JH. What is the role of ambulatory blood pressure monitoring in the management of hypertensive patients? Hypertension. 1985 Mar-Apr;7(2):171-7. doi: 10.1161/01.hyp.7.2.171.
- Background: PubMed 3889967Thailer SA, Friedman R, Harshfield GA, Pickering TG. Psychologic differences between high-, normal-, and low-renin hypertensives. Psychosom Med. 1985 May-Jun;47(3):294-7. doi: 10.1097/00006842-198505000-00007.
- Background: PubMed 3891153Pickering TG, Harshfield GA, Laragh JH. Ambulatory versus casual blood pressure in the diagnosis of hypertensive patients. Clin Exp Hypertens A. 1985;7(2-3):257-66. doi: 10.3109/10641968509073545. No abstract available.
- BackgroundHarshfield GA, Pickering TG, Blank S, Laragh JH: How Well do Casual Blood Pressures Reflect Ambulatory Blood Pressure? In: Blood Pressure Recording in the Clinical Management of Hypertension. Giuseppe G (Ed). Edizioni L, Pozzi, pp. 50-54, 1985
- Background: PubMed 2934328Lutas EM, Devereux RB, Reis G, Alderman MH, Pickering TG, Borer JS, Laragh JH. Increased cardiac performance in mild essential hypertension. Left ventricular mechanics. Hypertension. 1985 Nov-Dec;7(6 Pt 1):979-88. doi: 10.1161/01.hyp.7.6.979.
- BackgroundSchneiderman N, Pickering TG: Cardiovascular Measures of Physiologic Reactivity. In: Handbook of Stress, Reactivity, & Cardiovascular Disease. Matthews KA, Weiss SM, Detre T, Dembroski TM, Falkner B, Manuck SB, Williams RB, Jr. (Eds). John Wiley & Sons, Inc, New York, pp. 145-186, 1986
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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 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 NCT00005170, which also lists 57 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.