Cohort Study of Heart Rate Variability

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005399
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: August 2004
  Purpose

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
Cardiovascular Diseases
Myocardial Ischemia
Carotid Stenosis
Hypertension
Diabetes Mellitus
Heart Diseases

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: August 1996
Estimated Study Completion Date: June 2001
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005399

Sponsors and Collaborators
Investigators
Investigator: Gerardo Heiss University of North Carolina
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005399     History of Changes
Other Study ID Numbers: 4313
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on April 14, 2014