Cardiovascular DiseasesNCT00005366
Biobehavioral Mechanisms of Blood Pressure Regulation
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To investigate the role of biobehavioral factors in the pathogenesis of concentric left ventricular hypertrophy. Read more about this study
- Who is it for?
- Ages 25 to 39 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1993to Aug 1998
- 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 25 to 39 years
- All sexes
- No healthy volunteers
- Adult
No eligibility criteria
About this study
To investigate the role of biobehavioral factors in the pathogenesis of concentric left ventricular hypertrophy.
Read the detailed description
BACKGROUND:
Hypertension is more prevalent in Black than white men, and is more prevalent in men than women. Furthermore, even controlling for blood pressure, concentric left ventricular hypertrophy, an early structural adaptation of hypertension, is more prevalent in Black than white men, and more prevalent in men than women. Concentric left ventricular hypertrophy is the strongest predictor, other than age, of the cardiovascular morbidity associated with high blood pressure.
DESIGN NARRATIVE:
In a biracial sample, concentric left ventricular hypertrophy and concentric remodelling were assessed by echocardiographic measures of left ventricular mass and relative wall thickness. Laboratory procedures were used to: (i) assess hemodynamic and neurohumoral responses during exposure to a diverse battery of physical and psychological stressors, and; (ii) evaluate alpha and beta adrenergic receptor responsiveness, baroreceptor reflex gain and minimal forearm vascular resistance. Since blood pressure during a typical workday was an established predictor of left ventricular hypertrophy, it was also assessed. A new biobehavioral model was tested that implicated the hemodynamic pattern of behaviorally-evoked pressor responses in the pathogenesis of concentric left ventricular hypertrophy. One prediction of this model was that a predisposition to exhibit increased vascular resistance during stress (characteristic of black men) would favor the development of concentric hypertrophy. Thus, systemic vascular resistance responses, evaluated in the laboratory, were hypothesized to independently predict left ventricular mass and relative wall thickness, even after controlling for established risk factors, including workday blood pressure. Sympathetic nervous system function was examined to test hypothesized mechanisms responsible for race and gender differences in the hemodynamic patterns of blood pressure regulation. The results of these studies emphasized the importance of race and gender in prescribing pharmacological and/or behavioral treatment for hypertensive heart disease.
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 1993
- Study completionAug 1998
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005366
- Sponsor's protocol ID
- 4253
- Other IDs
- R01HL049427
- Status last verified
- Apr 2001
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Watkins LL, Grossman P, Sherwood A. Noninvasive assessment of baroreflex control in borderline hypertension. Comparison with the phenylephrine method. Hypertension. 1996 Aug;28(2):238-43. doi: 10.1161/01.hyp.28.2.238.
PubMed 8707388Sherwood A, May CW, Siegel WC, Blumenthal JA. Ethnic differences in hemodynamic responses to stress in hypertensive men and women. Am J Hypertens. 1995 Jun;8(6):552-7. doi: 10.1016/0895-7061(95)00036-O.
PubMed 7662238Blumenthal JA, Thyrum ET, Gullette ED, Sherwood A, Waugh R. Do exercise and weight loss reduce blood pressure in patients with mild hypertension? N C Med J. 1995 Feb;56(2):92-5.
PubMed 7898595Sherwood A, Hinderliter AL, Light KC. Physiological determinants of hyperreactivity to stress in borderline hypertension. Hypertension. 1995 Mar;25(3):384-90. doi: 10.1161/01.hyp.25.3.384.
PubMed 7875764Carels RA, Blumenthal JA, Sherwood A. Emotional responsivity during daily life: relationship to psychosocial functioning and ambulatory blood pressure. Int J Psychophysiol. 2000 Apr;36(1):25-33. doi: 10.1016/s0167-8760(99)00101-4.
PubMed 10700620Sherwood A, Johnson K, Blumenthal JA, Hinderliter AL. Endothelial function and hemodynamic responses during mental stress. Psychosom Med. 1999 May-Jun;61(3):365-70. doi: 10.1097/00006842-199905000-00017.
PubMed 10367618Carels RA, Szczepanski R, Blumenthal JA, Sherwood A. Blood pressure reactivity and marital distress in employed women. Psychosom Med. 1998 Sep-Oct;60(5):639-43. doi: 10.1097/00006842-199809000-00022.
PubMed 9773771Watkins LL, Grossman P, Krishnan R, Sherwood A. Anxiety and vagal control of heart rate. Psychosom Med. 1998 Jul-Aug;60(4):498-502. doi: 10.1097/00006842-199807000-00018.
PubMed 9710297Carels RA, Sherwood A, Blumenthal JA. Psychosocial influences on blood pressure during daily life. Int J Psychophysiol. 1998 Mar;28(2):117-29. doi: 10.1016/s0167-8760(97)00090-1.
PubMed 9545650Carels RA, Sherwood A, Szczepanski R, Blumenthal JA. Ambulatory blood pressure and marital distress in employed women. Behav Med. 2000 Summer;26(2):80-5. doi: 10.1080/08964280009595755.
PubMed 11147293
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
- Biobehavioral Mechanisms of Blood Pressure Regulation
- ClinicalTrials.gov ID
- NCT00005366
- Acronym / sponsor ID
- 4253
- 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 1993
- Study completion
- Aug 1998 (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 investigate the role of biobehavioral factors in the pathogenesis of concentric left ventricular hypertrophy.
Detailed description
BACKGROUND:
Hypertension is more prevalent in Black than white men, and is more prevalent in men than women. Furthermore, even controlling for blood pressure, concentric left ventricular hypertrophy, an early structural adaptation of hypertension, is more prevalent in Black than white men, and more prevalent in men than women. Concentric left ventricular hypertrophy is the strongest predictor, other than age, of the cardiovascular morbidity associated with high blood pressure.
DESIGN NARRATIVE:
In a biracial sample, concentric left ventricular hypertrophy and concentric remodelling were assessed by echocardiographic measures of left ventricular mass and relative wall thickness. Laboratory procedures were used to: (i) assess hemodynamic and neurohumoral responses during exposure to a diverse battery of physical and psychological stressors, and; (ii) evaluate alpha and beta adrenergic receptor responsiveness, baroreceptor reflex gain and minimal forearm vascular resistance. Since blood pressure during a typical workday was an established predictor of left ventricular hypertrophy, it was also assessed. A new biobehavioral model was tested that implicated the hemodynamic pattern of behaviorally-evoked pressor responses in the pathogenesis of concentric left ventricular hypertrophy. One prediction of this model was that a predisposition to exhibit increased vascular resistance during stress (characteristic of black men) would favor the development of concentric hypertrophy. Thus, systemic vascular resistance responses, evaluated in the laboratory, were hypothesized to independently predict left ventricular mass and relative wall thickness, even after controlling for established risk factors, including workday blood pressure. Sympathetic nervous system function was examined to test hypothesized mechanisms responsible for race and gender differences in the hemodynamic patterns of blood pressure regulation. The results of these studies emphasized the importance of race and gender in prescribing pharmacological and/or behavioral treatment for hypertensive heart disease.
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
- 25 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 8707388Watkins LL, Grossman P, Sherwood A. Noninvasive assessment of baroreflex control in borderline hypertension. Comparison with the phenylephrine method. Hypertension. 1996 Aug;28(2):238-43. doi: 10.1161/01.hyp.28.2.238.
- Background: PubMed 7662238Sherwood A, May CW, Siegel WC, Blumenthal JA. Ethnic differences in hemodynamic responses to stress in hypertensive men and women. Am J Hypertens. 1995 Jun;8(6):552-7. doi: 10.1016/0895-7061(95)00036-O.
- Background: PubMed 7898595Blumenthal JA, Thyrum ET, Gullette ED, Sherwood A, Waugh R. Do exercise and weight loss reduce blood pressure in patients with mild hypertension? N C Med J. 1995 Feb;56(2):92-5.
- Background: PubMed 7875764Sherwood A, Hinderliter AL, Light KC. Physiological determinants of hyperreactivity to stress in borderline hypertension. Hypertension. 1995 Mar;25(3):384-90. doi: 10.1161/01.hyp.25.3.384.
- Background: PubMed 10700620Carels RA, Blumenthal JA, Sherwood A. Emotional responsivity during daily life: relationship to psychosocial functioning and ambulatory blood pressure. Int J Psychophysiol. 2000 Apr;36(1):25-33. doi: 10.1016/s0167-8760(99)00101-4.
- Background: PubMed 10367618Sherwood A, Johnson K, Blumenthal JA, Hinderliter AL. Endothelial function and hemodynamic responses during mental stress. Psychosom Med. 1999 May-Jun;61(3):365-70. doi: 10.1097/00006842-199905000-00017.
- Background: PubMed 9773771Carels RA, Szczepanski R, Blumenthal JA, Sherwood A. Blood pressure reactivity and marital distress in employed women. Psychosom Med. 1998 Sep-Oct;60(5):639-43. doi: 10.1097/00006842-199809000-00022.
- Background: PubMed 9710297Watkins LL, Grossman P, Krishnan R, Sherwood A. Anxiety and vagal control of heart rate. Psychosom Med. 1998 Jul-Aug;60(4):498-502. doi: 10.1097/00006842-199807000-00018.
- Background: PubMed 9545650Carels RA, Sherwood A, Blumenthal JA. Psychosocial influences on blood pressure during daily life. Int J Psychophysiol. 1998 Mar;28(2):117-29. doi: 10.1016/s0167-8760(97)00090-1.
- Background: PubMed 11147293Carels RA, Sherwood A, Szczepanski R, Blumenthal JA. Ambulatory blood pressure and marital distress in employed women. Behav Med. 2000 Summer;26(2):80-5. doi: 10.1080/08964280009595755.
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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 NCT00005366, 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 18 Feb 2016.