Text Size

Heart Rate, Baroreflex Sensitivity and Cardiovascular Morbidity and Mortality in the Population (PPSIII)

This study is currently recruiting participants.
Verified December 2011 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT00741728
First received: August 25, 2008
Last updated: December 8, 2011
Last verified: December 2011
History of Changes
  Purpose

The aim of the present PPS3 study is (1) to assess the determinants of the regulation of heart rate and blood pressure variations and carotid properties (under different physiologic stimulations) and (2) to evaluate the respective contribution of heart rate, blood pressure variations and carotid properties to cardiovascular morbidity and mortality including sudden death during 10 years at least in healthy considered subjects.


Condition Intervention
Community Based Study
Cardiovascular Disease
Sudden Death
Blood Pressure
 Other: Spider flash EKG, echocardiography tracking, step test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Heart Rate, Baroreflex Sensitivity and Cardiovascular Morbidity and Mortality in the Population. The Paris Prospective Study III

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • cardiovascular disease [ Time Frame: after 10 years of follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • heart rate parameters and baroreflex sensitivity [ Time Frame: after 2 years of recruitment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples and DNA taken from fresh blood


Estimated Enrollment: 10000
Study Start Date: June 2008
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
general population
Observational study of 10000 adult men and women from the general population who benefited from a free extensive health check up in Paris, France
 Other: Spider flash EKG, echocardiography tracking, step test
cardiac rhythm recorded during health check up, echocardiography tracking of the right common carotid, step test during 2 minutes

Detailed Description:

Overall, 10 000 men and women will be recruited during two years for an extensive clinical examination including a 2h holter ECG, a carotid doppler echo tracking, a step test, as well as blood and DNA collections. Thereafter, the cardiovascular morbidity and mortality of the participants will be followed up for 10 years at least.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adult men and women affiliated to the public French Health Insurance System who benefited from a free general health check up paid by the French Health Insurance System

Criteria

Inclusion Criteria:

  • 50-75 years, French speaking, given consent for genetic analysis,
  • written consent for participating in the study

Exclusion Criteria:

  • <50 years and >75 years,
  • no French speaking,
  • current pregnancy,
  • chronic severe disease,
  • disagreement for genetic analysis,
  • step test considered as non possible or non advisable by medical decision.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741728

Contacts
Contact: Xavier Jouven, MD, PhD 1 56 09 36 87 ext 33 xavier.jouven@egp.aphp.fr
Contact: Jean-Philippe Empana, MD, PhD 1 53 98 80 20 ext 33 jean-philippe.empana@inserm.fr

Locations
France
Investigations Pré cliniques et Preventives de Paris Recruiting
Paris, France, 75016
Contact: Jean Philippe Empana, MD, PhD     33 1 53 98 80 20 ext 33     jean-philippe.empana@inserm.fr    
Principal Investigator: Xavier Jouven, MD, PhD            
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Director: Xavier Jouven, MD, PhD INSERM and APHP
Principal Investigator: Jean-Philippe Empana, MD, PhD Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Pierre Boutouyrie, MD, PhD INSERM and APHP
  More Information

Additional Information:
official website of the French National Institute for Health and Medical Research  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT00741728     History of Changes
Other Study ID Numbers: C07-39, 2007-A01386-47
Study First Received: August 25, 2008
Last Updated: December 8, 2011
Health Authority: France: Direction Générale de la Santé

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
epidemiology
risk factors
heart rate
baroreflex sensitivity
sudden death

Additional relevant MeSH terms:
Cardiovascular Diseases
Death
Death, Sudden
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013