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. Identifier: NCT00005399
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : April 12, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
To examine factors affecting heart rate variability (HRV) and the role of HRV in heart disease. Specifically, to examine the role of HRV: as a predictor of fatal and nonfatal ischemic heart disease over a six year follow-up of the Atherosclerosis Risk in Communities (ARIC) population based, bi-ethnic cohort; on the six year progression of carotid atherosclerosis measured by B-mode ultrasound; and on the incidence of hypertension. Also, to study the effect of elevated fasting insulin, glucose, diabetes mellitus, and other metabolic abnormalities on changes in HRV over nine years of follow-up.

Condition or disease Intervention/treatment
Cardiovascular Diseases Myocardial Ischemia Carotid Stenosis Hypertension Diabetes Mellitus Heart Diseases Other: No interventions

Detailed Description:


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
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Study of Heart Rate Variability
Study Start Date : August 1996
Actual Primary Completion Date : June 2001
Actual Study Completion Date : June 2001

Intervention Details:
    Other: No interventions
    No interventions

Primary Outcome Measures :
  1. Incident coronary heart disease and stroke events [ Time Frame: 10-year follow-up ]

Secondary Outcome Measures :
  1. all-cause and cause-specific mortality [ Time Frame: 10-year follow-up ]

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Ages Eligible for Study:   45 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Population-based sample of adults ages 45-64 years
Residents of 4 geographically defined areas

Information from the National Library of Medicine

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 identifier (NCT number): NCT00005399

Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Gerardo Heiss University of North Carolina

Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT00005399     History of Changes
Other Study ID Numbers: 96-0453
R01HL055669 ( U.S. NIH Grant/Contract )
4313 ( Other Identifier: NHLBI )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Carotid Stenosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases