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

Heart Rate, Baroreflex Sensitivity and Cardiovascular Morbidity and Mortality in the Population. The Paris Prospective Study III

The aim of the present Paris Prospective Study III (PPS3) 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.

Study Overview

Detailed Description

Overall, 10 157 men and women have been recruited during May 2008 and June 2012 for an extensive clinical examination including a 2h holter electrocardiography (ECG), a carotid doppler echo tracking, a step test, as well as blood and DNA collections. Since then, the cardiovascular morbidity and mortality of the participants is being followed up for 10 years at least and will continue up to 2032.

Study Type

Observational

Enrollment (Actual)

10157

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75016
        • Investigations Pré cliniques et Preventives de Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
general population
Observational study of 10157 adult men and women from the general population who benefited from a free extensive health check up in Paris, France
cardiac rhythm recorded during health check up, vascular aging parameters and baroreflex sensitivity recorded during carotid echotracking of the right common carotid artery , step test during 2 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiovascular disease (CVD)
Time Frame: through study completion, an average of 24 years
incident coronary heart disease (CHD), stroke, sudden death, mortality
through study completion, an average of 24 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate parameters and baroreflex sensitivity
Time Frame: 4 Years
as measured on the Spider Flash ECG and the carotid echotracking
4 Years
other CVD outcomes
Time Frame: through study completion, an average of 24 years
heart failure, arterial aneurysms, venous thromboembolism (VTE), pulmonary embolism, arrhythmic events (atrial fibrillation, flutter)
through study completion, an average of 24 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2008

Primary Completion (Estimated)

June 1, 2032

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

August 25, 2008

First Submitted That Met QC Criteria

August 25, 2008

First Posted (Estimated)

August 26, 2008

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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