Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000546
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
1999-10-27
Brief Title:
Stress Reduction and Atherosclerotic CVD in Blacks
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-10
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 evaluate the effectiveness of stress reduction with Transcendental Meditation TM on left ventricular hypertrophy left ventricular function blood pressure psychosocial stress and quality of life and cardiovascular disease risk factors
Detailed Description:
BACKGROUND
Blacks in the United States have disproportionately high rates of cardiovascular disease and mortality Left ventricular hypertrophy the primary manifestation of hypertensive heart disease and a major independent predictor of cardiovascular mortality is twice as prevalent in Blacks with hypertension as in whites Research has implicated chronic socio-environmental and psychological stress in the etiology of hypertension and left ventricular hypertrophy in Blacks The trial seeks to investigate directly the impact of stress reduction programs for treating hypertensive heart disease in Blacks since conventional antihypertensive drug therapies are less successful than expected Moreover these therapies frequently have adverse side effects on quality of life and have low compliance rates particularly in minorities
DESIGN NARRATIVE
The first study conducted between 1994 and 1999 used transcendental meditation for stress reduction in hypertensive heart disease The study was randomized and blind Subjects were randomized to practice TM for twelve months or to receive health education The following measurements were obtained left ventricular mass and function using echocardiography clinic blood pressure and ambulatory blood pressure monitoring urinary sodium excretion alcohol consumption weight physical activity cigarette smoking and previous use of antihypertensive medication various quality of life measures including physical functioning psychosocial functioning subjective symptoms trait anger and anger-expression stress impact scale personal efficacy and health locus of control social supports ego development and social desirability
The trial was part of the Collaborative Projects on Minority Health an Institute- initiated program to foster collaborative clinical research that focused on new and improved approaches for diagnosis management and prevention of cardiovascular lung and blood diseases in minorities The trial was part of a two-grant collaboration on Nonpharmacologic Treatments for Managing Hypertension in African American Adults Ernest Johnson R01HL50516the Program Coordinator collaborated with Robert Schneider R01HL51519 The objectives of their studies were complementary and the collaborative arrangements allowed them to determine the effectiveness of different approaches to stress management in comparison with a control group that was comparable at both sites In addition the treatment schedules in both studies resulted in identical contact time length of interventions expectations regarding treatment effectiveness and follow-up assessment periods As a result a considerable degree of pooling of data for analysis was possible
Dr Schneiders study was renewed in FY 1999 to conduct a randomized single-blind controlled community-based trial involving 184 African American subjects with known coronary heart disease Male and female subjects are enrolled at the on-going field site Martin Luther King-Drew Medical Center in inner city Los Angeles After baseline testing subjects are randomized to either active stress reduction with TM or health education control-both in addition to usual medical care-and posttested after 12 months The primary outcome is carotid artery atherosclerosis IMT measured non-invasively by quantitative B-mode ultrasonography Secondary measures include traditional CVD risk factors blood pressure lipids smoking exercise psychosocial stress quality of life and cost effectiveness
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Blacks in the United States have disproportionately high rates of cardiovascular disease and mortality Left ventricular hypertrophy the primary manifestation of hypertensive heart disease and a major independent predictor of cardiovascular mortality is twice as prevalent in Blacks with hypertension as in whites Research has implicated chronic socio-environmental and psychological stress in the etiology of hypertension and left ventricular hypertrophy in Blacks The trial seeks to investigate directly the impact of stress reduction programs for treating hypertensive heart disease in Blacks since conventional antihypertensive drug therapies are less successful than expected Moreover these therapies frequently have adverse side effects on quality of life and have low compliance rates particularly in minorities
DESIGN NARRATIVE
The first study conducted between 1994 and 1999 used transcendental meditation for stress reduction in hypertensive heart disease The study was randomized and blind Subjects were randomized to practice TM for twelve months or to receive health education The following measurements were obtained left ventricular mass and function using echocardiography clinic blood pressure and ambulatory blood pressure monitoring urinary sodium excretion alcohol consumption weight physical activity cigarette smoking and previous use of antihypertensive medication various quality of life measures including physical functioning psychosocial functioning subjective symptoms trait anger and anger-expression stress impact scale personal efficacy and health locus of control social supports ego development and social desirability
The trial was part of the Collaborative Projects on Minority Health an Institute- initiated program to foster collaborative clinical research that focused on new and improved approaches for diagnosis management and prevention of cardiovascular lung and blood diseases in minorities The trial was part of a two-grant collaboration on Nonpharmacologic Treatments for Managing Hypertension in African American Adults Ernest Johnson R01HL50516the Program Coordinator collaborated with Robert Schneider R01HL51519 The objectives of their studies were complementary and the collaborative arrangements allowed them to determine the effectiveness of different approaches to stress management in comparison with a control group that was comparable at both sites In addition the treatment schedules in both studies resulted in identical contact time length of interventions expectations regarding treatment effectiveness and follow-up assessment periods As a result a considerable degree of pooling of data for analysis was possible
Dr Schneiders study was renewed in FY 1999 to conduct a randomized single-blind controlled community-based trial involving 184 African American subjects with known coronary heart disease Male and female subjects are enrolled at the on-going field site Martin Luther King-Drew Medical Center in inner city Los Angeles After baseline testing subjects are randomized to either active stress reduction with TM or health education control-both in addition to usual medical care-and posttested after 12 months The primary outcome is carotid artery atherosclerosis IMT measured non-invasively by quantitative B-mode ultrasonography Secondary measures include traditional CVD risk factors blood pressure lipids smoking exercise psychosocial stress quality of life and cost effectiveness
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 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 |
|---|---|---|---|
| R01HL051519 | NIH | None | httpsreporternihgovquickSearchR01HL051519 |