Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne Identifier:
First received: September 24, 2008
Last updated: February 26, 2014
Last verified: February 2014

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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events on a Prospective Cohort of Subjects Aged 65 Years

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events [ Time Frame: During all the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Presence and severity of clinically silent stroke revealed through brain MRI [ Time Frame: Years 1, 3 and 5 ] [ Designated as safety issue: No ]
  • Neuropsychological performance [ Time Frame: Years 1, 3 and 5 ] [ Designated as safety issue: No ]
  • ANS activity measured by heart rate variability + spontaneous baroreflex + blood pressure variability [ Time Frame: Years 1, 3 and 5 ] [ Designated as safety issue: No ]
  • Biological data : fasting blood glucose, total and HDL cholesterol, triglycerides and CRP [ Time Frame: Years 1, 3 and 5 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum, DNA

Enrollment: 1011
Study Start Date: January 2001
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
PROOF cohort
Healthy inhabitants of the city of Saint-Etienne, France, and aged 65 years at the inclusion date.

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.


Ages Eligible for Study:   65 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00759304

Centre Hospitalier de Saint-Etienne
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Principal Investigator: Jean-Claude BARTHELEMY, MD PhD CHU de Saint-Etienne
  More Information


Additional publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne Identifier: NCT00759304     History of Changes
Other Study ID Numbers: 9808112
Study First Received: September 24, 2008
Last Updated: February 26, 2014
Health Authority: France: Ministry of Health
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
cardiovascular risk factors
Autonomic nervous system
Myocardiac infarction
Neuropsychological evaluation
Prospective cohort processed this record on March 03, 2015