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Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00759304
Acronym
PROOF
Enrollment
1011
Registered
2008-09-25
Start date
2000-01-02
Completion date
2026-12-31
Last updated
2025-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Aging, cardiovascular risk factors, Autonomic nervous system, stroke, Myocardiac infarction, Neuropsychological evaluation, Prospective cohort

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.

Interventions

None listed

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular eventsDuring all the study

Secondary

MeasureTime frame
Presence and severity of clinically silent stroke revealed through brain MRIYears 1, 3 and 5
Neuropsychological performanceYears 1, 3 and 5
ANS activity measured by heart rate variability + spontaneous baroreflex + blood pressure variabilityYears 1, 3 and 5
Biological data : fasting blood glucose, total and HDL cholesterol, triglycerides and CRPYears 1, 3 and 5

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026