Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events

Healthy Clinical Trial

— PROOF  

Official title:

Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events on a Prospective Cohort of Subjects Aged 65 Years

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00759304
• Other study ID #: 9808112
• Status: Active, not recruiting
• Start date: January 2, 2000
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The regulatory effects of the autonomic nervous system (ANS) concern almost all organs which permanently feed information back to this global biological vigilance system controlling allostasis. Heart rate fluctuations are highly dependent on ANS control, making the heart one of the best indicators of ANS activity.

Low ANS activity level is associated with severe cardiac and cerebral events, as well as to death from any cause in the general population.

This PROOF study was hence designed to evaluate ANS activity levels among a healthy retired population, but should these levels decline overtime, to use this as a predictor of cardiovascular and cerebrovascular events, taking into account established cardiovascular risk factors.

Description:

The main goal of this PROOF study is to evaluate, on a selected prospective cohort of subjects aged 65 years upon study entry, the prognostic values of ANS activity levels measured at preset times, and more specifically, of its decline over the follow-up period, for fatal and non-fatal cardiovascular and cerebrovascular events.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1011
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 65 Years

Eligibility

Inclusion Criteria:

• 65 years old

• informed consent signed

Exclusion Criteria:

• prior myocardiac infarction

• prior stroke

• hearth failure

• atrial fibrillation

• insulin-treated diabetes mellitus

• cardiac pacemaker

• disease limiting life expectancy to < 5 years

• contraindication to brain MRI

• living in an institution

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
France	Centre Hospitalier de Saint-Etienne	Saint-Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (5)

Barthelemy JC, Pichot V, Dauphinot V, Celle S, Laurent B, Garcin A, Maudoux D, Kerleroux J, Lacour JR, Kossovsky M, Gaspoz JM, Roche F. Autonomic nervous system activity and decline as prognostic indicators of cardiovascular and cerebrovascular events: th — View Citation

Gosse P, Roche F, Dauphinot V, Maudoux D, Pichot V, Barthelemy JC. Components of arterial stiffness in a population of 65-year-old subjects: PROOF study. J Hypertens. 2008 Jun;26(6):1138-46. doi: 10.1097/HJH.0b013e3282fa142b. — View Citation

Pichot V, Buffiere S, Gaspoz JM, Costes F, Molliex S, Duverney D, Roche F, Barthelemy JC. Wavelet transform of heart rate variability to assess autonomic nervous system activity does not predict arousal from general anesthesia. Can J Anaesth. 2001 Oct;48(9):859-63. doi: 10.1007/BF03017350. — View Citation

Roche F, Gaspoz JM, Da Costa A, Isaaz K, Duverney D, Pichot V, Costes F, Lacour JR, Barthelemy JC. Frequent and prolonged asymptomatic episodes of paroxysmal atrial fibrillation revealed by automatic long-term event recorders in patients with a negative 24-hour Holter. Pacing Clin Electrophysiol. 2002 Nov;25(11):1587-93. doi: 10.1046/j.1460-9592.2002.01587.x. — View Citation

Rouch I, Anterion CT, Dauphinot V, Kerleroux J, Roche F, Barthelemy JC, Laurent B. Cognitive complaints, neuropsychological performance and affective disorders in elderly community residents. Disabil Rehabil. 2008;30(23):1794-802. doi: 10.1080/09638280701 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events		During all the study
Secondary	Presence and severity of clinically silent stroke revealed through brain MRI		Years 1, 3 and 5
Secondary	Neuropsychological performance		Years 1, 3 and 5
Secondary	ANS activity measured by heart rate variability + spontaneous baroreflex + blood pressure variability		Years 1, 3 and 5
Secondary	Biological data : fasting blood glucose, total and HDL cholesterol, triglycerides and CRP		Years 1, 3 and 5