Cohort Study of Heart Rate Variability
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00005399|
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : April 12, 2016
|Condition or disease||Intervention/treatment|
|Cardiovascular Diseases Myocardial Ischemia Carotid Stenosis Hypertension Diabetes Mellitus Heart Diseases||Other: No interventions|
Heart rate variability analysis has been widely used in clinical research as a noninvasive measurement of autonomic function. It has been found to be associated with post-myocardial infarction mortality, hypertension, sudden cardiac death, atherosclerosis, and diabetes. However, little epidemiologic research on HRV had been reported prior to this study in 1996. Almost no data were available on the population distribution of HRV, its correlates in populations, the factors associated with changes in HRV over time, or on the cardiovascular sequelae of impaired autonomic function assessed by HRV obtained from population-based prospective studies.
The study was ancillary to ARIC, a population-based, longitudinal study of cardiovascular and pulmonary diseases. The baseline exam was completed in 1987 to 1988, followed by yearly contacts and re-examinations every three years. The present study built on the data collected by the ARIC investigators by retrieving and processing beat-to-beat heart rate data collected during the baseline exam. Five minutes of beat-to-beat heart rate data were obtained from the ARIC cohort participants during their third follow-up visit (Visit) 4 in 1996 through 1998. Time and frequency domain HRV indices were derived for an assessment of autonomic function. The following HRV indices were computed both for the baseline and the nine-year follow-up exam (1996 through 1998) on the 13,000 members of the ARIC cohort: time domain indices; mean heart rate, minimum and maximum heart rate, standard deviation of all normal R-R intervals, the coefficient of variation of all normal R-R intervals, root mean square of the differences of successive R-R intervals, and the proportion of adjacent R-R intervals. Frequency domain indices were also computed, including high frequency power, low frequency power, and the high/low frequency power ratio.
|Study Type :||Observational|
|Actual Enrollment :||111654 participants|
|Official Title:||Cohort Study of Heart Rate Variability|
|Study Start Date :||August 1996|
|Primary Completion Date :||June 2001|
|Study Completion Date :||June 2001|
Other: No interventions
- Incident coronary heart disease and stroke events [ Time Frame: 10-year follow-up ]
- all-cause and cause-specific mortality [ Time Frame: 10-year follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005399
|Principal Investigator:||Gerardo Heiss||University of North Carolina|