Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events "PROOF"

Active, not recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Subjects were recruited amongst the inhabitants of the city of Saint-Etienne, France, and were eligible if aged 65 at the inclusion date.

Outcomes

Type Measure Time Frame Safety Issue
Primary Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events During all the study No
Secondary Presence and severity of clinically silent stroke revealed through brain MRI Years 1, 3 and 5 No
Secondary Neuropsychological performance Years 1, 3 and 5 No
Secondary ANS activity measured by heart rate variability + spontaneous baroreflex + blood pressure variability Years 1, 3 and 5 No
Secondary Biological data : fasting blood glucose, total and HDL cholesterol, triglycerides and CRP Years 1, 3 and 5 No

Biospecimen Retention:Samples With DNA - Serum, DNA

Sponsors