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Active, Not Recruiting

NCT Number: NCT00759304

Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

65 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de Saint-Etienne

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events

    Time frame: During all the study

Secondary outcomes

  1. Presence and severity of clinically silent stroke revealed through brain MRI

    Time frame: Years 1, 3 and 5

  2. Neuropsychological performance

    Time frame: Years 1, 3 and 5

  3. ANS activity measured by heart rate variability + spontaneous baroreflex + blood pressure variability

    Time frame: Years 1, 3 and 5

  4. Biological data : fasting blood glucose, total and HDL cholesterol, triglycerides and CRP

    Time frame: Years 1, 3 and 5

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: PROOF

Important dates

Study start
2000
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2008
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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