Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005192
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2000-05-25
Brief Title:
Psychophysiology of Cardiovascular Reactivity
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine why Black Americans have a higher prevalence of hypertension than whites by examining the interactions of psychosocial stressors and suppressed hostility with genetic or constitutional factors
Detailed Description:
BACKGROUND
Blacks in the United States have a much greater prevalence of essential hypertension than whites The prevalence of hypertension for adults aged 18-74 has been estimated at 157 percent for white women 185 percent for white men 278 percent for Black men and 286 percent for Black women Among adults who underwent screening for the Hypertension Detection and Follow-up Program 362 percent of Black males and 382 percent of Black females either had diastolic blood pressures at least as high as 95 mmHg or were taking antihypertensive medications The Black-white ratio for the prevalence of hypertension in this survey was approximately 2 Reportedly the prevalence of hypertension among inner city Blacks may be as high as 50 percent The exact causes of the disparity in hypertension prevalence between Blacks and whites are unknown but genetic predisposition psychosocial stress and life-style factors such as high sodium ingestion and obesity have been implicated None of these factors alone appears sufficient to account for the difference in the prevalence of hypertension between Blacks and whites suggesting that multiple factors andor interactions between factors may be involved
DESIGN NARRATIVE
The study is supported by a program project grant and thus includes many subprojects Projects 1A through 1C were supported beginning in 1986 Project 1A examined the effects of cardiovascular and hormonal responses to standardized laboratory challenges as a function of race sex age and normal blood pressure versus borderline hypertension The subjects were classified according to four categories Black or white race male or female sex normal or raised blood pressure and ages 25-39 or 40-54 giving a total of 16 cells with 15 subjects in each The subjects were given a physical examination electrocardiogram blood screening test as well as a battery of special tests including a Structured Interview for Type A behavior pattern playing a video game a test designed to elicit anger and exercise on a bicycle ergometer During these tasks subjects were monitored for heart rate and blood pressure and blood was sampled for plasma catecholamines renin cortisol aldosterone and vasopressin Various psychological tests were administered including the Cook-Medley hostility scale the Life Orientation test a job stress scale the John Henryism Active Coping Scale and others Urine samples were collected for electrolyte and catecholamine excretion and ambulatory blood pressure was monitored on a work day and on a non-work day
Project IB examined the effects of acute sodium loading and depletion on cardiovascular and hormonal reactivity as a function of race and sex Normotensive subjects were classified according to two categories Black or white race male or female sex with four cells of 15 subjects each After the initial medical examination subjects were seen three times at intervals of two weeks Before each visit three overnight urine collections were made for electrolyte excretion evaluation On these three visits subjects were randomized to either a control day a sodium loading day or sodium depletion day On each of these days subjects were given three reactivity tests including the video game exercise test and speech-stressor task The same psychological tests as in Project 1A were given on the mornings of the three testing days
Project 1C was a five-year follow-up of 80 subjects in the Study of Biobehavioral Factors Affecting Hypertension in Blacks Subjects had a routine history and physical exam and were then given the Type A Interview a video game and an exercise task Subjects also provided three overnight urine samples
Two substudies were also conducted The goal of substudy 1 was to determine what psychosocial factors predicted cardiovascular responding at work in Black and white women Black and white normotensive nurses between the ages of 20-45 years served as subjects Substudy 2 examined the affective and physiological responses of Black and white college students during challenge Normotensive Black and white men and women were monitored for blood pressure and heart rate during rest and during three tasks including mirror star tracing hand immersion cold pressor and speech stressor
The program project was renewed in 1996 Subproject 7 addresses the the problem of modifying risk in youth with high blood pressure The subproject compares adolescents with high versus normal blood pressure in terms of fasting insulin oral glucose tolerance adiposity aerobic fitness diet cardiac mass autonomic reactivity psychosocial characteristics and family medical history Subproject 7 renewed as Subproject 1 in FY 2001 examines the long-term effects of three intervention conditions a three month self-management intervention a six month augmented self-management skill acquisition intervention program and usual care Subproject 8 renewed as Subproject 2 in FY 2001 involves behavioral intervention in post-myocardial infarction patients receiving standard pharmacological treatment or standard pharmacological treatment plus behavioral treatment including stress management dietary supervision and self-directed exercise
Blacks in the United States have a much greater prevalence of essential hypertension than whites The prevalence of hypertension for adults aged 18-74 has been estimated at 157 percent for white women 185 percent for white men 278 percent for Black men and 286 percent for Black women Among adults who underwent screening for the Hypertension Detection and Follow-up Program 362 percent of Black males and 382 percent of Black females either had diastolic blood pressures at least as high as 95 mmHg or were taking antihypertensive medications The Black-white ratio for the prevalence of hypertension in this survey was approximately 2 Reportedly the prevalence of hypertension among inner city Blacks may be as high as 50 percent The exact causes of the disparity in hypertension prevalence between Blacks and whites are unknown but genetic predisposition psychosocial stress and life-style factors such as high sodium ingestion and obesity have been implicated None of these factors alone appears sufficient to account for the difference in the prevalence of hypertension between Blacks and whites suggesting that multiple factors andor interactions between factors may be involved
DESIGN NARRATIVE
The study is supported by a program project grant and thus includes many subprojects Projects 1A through 1C were supported beginning in 1986 Project 1A examined the effects of cardiovascular and hormonal responses to standardized laboratory challenges as a function of race sex age and normal blood pressure versus borderline hypertension The subjects were classified according to four categories Black or white race male or female sex normal or raised blood pressure and ages 25-39 or 40-54 giving a total of 16 cells with 15 subjects in each The subjects were given a physical examination electrocardiogram blood screening test as well as a battery of special tests including a Structured Interview for Type A behavior pattern playing a video game a test designed to elicit anger and exercise on a bicycle ergometer During these tasks subjects were monitored for heart rate and blood pressure and blood was sampled for plasma catecholamines renin cortisol aldosterone and vasopressin Various psychological tests were administered including the Cook-Medley hostility scale the Life Orientation test a job stress scale the John Henryism Active Coping Scale and others Urine samples were collected for electrolyte and catecholamine excretion and ambulatory blood pressure was monitored on a work day and on a non-work day
Project IB examined the effects of acute sodium loading and depletion on cardiovascular and hormonal reactivity as a function of race and sex Normotensive subjects were classified according to two categories Black or white race male or female sex with four cells of 15 subjects each After the initial medical examination subjects were seen three times at intervals of two weeks Before each visit three overnight urine collections were made for electrolyte excretion evaluation On these three visits subjects were randomized to either a control day a sodium loading day or sodium depletion day On each of these days subjects were given three reactivity tests including the video game exercise test and speech-stressor task The same psychological tests as in Project 1A were given on the mornings of the three testing days
Project 1C was a five-year follow-up of 80 subjects in the Study of Biobehavioral Factors Affecting Hypertension in Blacks Subjects had a routine history and physical exam and were then given the Type A Interview a video game and an exercise task Subjects also provided three overnight urine samples
Two substudies were also conducted The goal of substudy 1 was to determine what psychosocial factors predicted cardiovascular responding at work in Black and white women Black and white normotensive nurses between the ages of 20-45 years served as subjects Substudy 2 examined the affective and physiological responses of Black and white college students during challenge Normotensive Black and white men and women were monitored for blood pressure and heart rate during rest and during three tasks including mirror star tracing hand immersion cold pressor and speech stressor
The program project was renewed in 1996 Subproject 7 addresses the the problem of modifying risk in youth with high blood pressure The subproject compares adolescents with high versus normal blood pressure in terms of fasting insulin oral glucose tolerance adiposity aerobic fitness diet cardiac mass autonomic reactivity psychosocial characteristics and family medical history Subproject 7 renewed as Subproject 1 in FY 2001 examines the long-term effects of three intervention conditions a three month self-management intervention a six month augmented self-management skill acquisition intervention program and usual care Subproject 8 renewed as Subproject 2 in FY 2001 involves behavioral intervention in post-myocardial infarction patients receiving standard pharmacological treatment or standard pharmacological treatment plus behavioral treatment including stress management dietary supervision and self-directed exercise
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01HL036588 | NIH | None | httpsreporternihgovquickSearchP01HL036588 |