Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events

Active, not recruiting

• Conditions: Healthy

• Registration Number: NCT00759304
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2000-01-02
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1011

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events	During all the study

Secondary Outcome Measures

Name	Time	Method
Presence and severity of clinically silent stroke revealed through brain MRI	Years 1, 3 and 5
Neuropsychological performance	Years 1, 3 and 5
ANS activity measured by heart rate variability + spontaneous baroreflex + blood pressure variability	Years 1, 3 and 5
Biological data : fasting blood glucose, total and HDL cholesterol, triglycerides and CRP	Years 1, 3 and 5

Trial Locations

Locations (1)

Centre Hospitalier de Saint-Etienne; 🇫🇷 Saint-Etienne, France