Cohort Study of Heart Rate Variability

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00005399
First received: May 25, 2000
Last updated: April 11, 2016
Last verified: April 2016

May 25, 2000
April 11, 2016
August 1996
June 2001   (final data collection date for primary outcome measure)
Incident coronary heart disease and stroke events [ Time Frame: 10-year follow-up ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00005399 on ClinicalTrials.gov Archive Site
all-cause and cause-specific mortality [ Time Frame: 10-year follow-up ] [ Designated as safety issue: No ]
Not Provided
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Cohort Study of Heart Rate Variability
Cohort Study of Heart Rate Variability
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.

BACKGROUND:

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.

DESIGN NARRATIVE:

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Population-based sample of adults ages 45-64 years
  • Cardiovascular Diseases
  • Myocardial Ischemia
  • Carotid Stenosis
  • Hypertension
  • Diabetes Mellitus
  • Heart Diseases
Other: No interventions
No interventions
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111654
June 2001
June 2001   (final data collection date for primary outcome measure)
Residents of 4 geographically defined areas
Both
45 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00005399
96-0453, R01HL055669, 4313
No
Not Provided
Not Provided
University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Gerardo Heiss University of North Carolina
University of North Carolina, Chapel Hill
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP