- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00741728
Heart Rate, Baroreflex Sensitivity and Cardiovascular Morbidity and Mortality in the Population (PPSIII)
February 10, 2026 updated by: Institut National de la Santé Et de la Recherche Médicale, France
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
Status
Active, not recruiting
Intervention / Treatment
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
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-
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Paris, France, 75016
- Investigations Pré cliniques et Preventives de Paris
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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
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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
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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
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as measured on the Spider Flash ECG and the carotid echotracking
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4 Years
|
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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)
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through study completion, an average of 24 years
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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
- Jouven X, Empana JP, Schwartz PJ, Desnos M, Courbon D, Ducimetiere P. Heart-rate profile during exercise as a predictor of sudden death. N Engl J Med. 2005 May 12;352(19):1951-8. doi: 10.1056/NEJMoa043012.
- Jouven X, Zureik M, Desnos M, Courbon D, Ducimetiere P. Long-term outcome in asymptomatic men with exercise-induced premature ventricular depolarizations. N Engl J Med. 2000 Sep 21;343(12):826-33. doi: 10.1056/NEJM200009213431201.
- Briet M, Bozec E, Laurent S, Fassot C, London GM, Jacquot C, Froissart M, Houillier P, Boutouyrie P. Arterial stiffness and enlargement in mild-to-moderate chronic kidney disease. Kidney Int. 2006 Jan;69(2):350-7. doi: 10.1038/sj.ki.5000047.
- Kornet L, Hoeks AP, Janssen BJ, Houben AJ, De Leeuw PW, Reneman RS. Neural activity of the cardiac baroreflex decreases with age in normotensive and hypertensive subjects. J Hypertens. 2005 Apr;23(4):815-23. doi: 10.1097/01.hjh.0000163151.50825.e2.
- Empana JP, Sykes DH, Luc G, Juhan-Vague I, Arveiler D, Ferrieres J, Amouyel P, Bingham A, Montaye M, Ruidavets JB, Haas B, Evans A, Jouven X, Ducimetiere P; PRIME Study Group. Contributions of depressive mood and circulating inflammatory markers to coronary heart disease in healthy European men: the Prospective Epidemiological Study of Myocardial Infarction (PRIME). Circulation. 2005 May 10;111(18):2299-305. doi: 10.1161/01.CIR.0000164203.54111.AE. Epub 2005 May 2.
- Deraz O, Range H, Boutouyrie P, Chatzopoulou E, Asselin A, Guibout C, Van Sloten T, Bougouin W, Andrieu M, Vedie B, Thomas F, Danchin N, Jouven X, Bouchard P, Empana JP. Oral Condition and Incident Coronary Heart Disease: A Clustering Analysis. J Dent Res. 2022 May;101(5):526-533. doi: 10.1177/00220345211052507. Epub 2021 Dec 7.
- Lisan Q, Tafflet M, Charles MA, Thomas F, Boutouyrie P, Guibout C, Haba-Rubio J, Perier MC, Pannier B, Marques-Vidal P, Jouven X, Empana JP. Self-reported body silhouette trajectories across the lifespan and excessive daytime sleepiness in adulthood: a retrospective analysis. The Paris Prospective Study III. BMJ Open. 2018 Mar 27;8(3):e020851. doi: 10.1136/bmjopen-2017-020851.
- Simon M, Boutouyrie P, Narayanan K, Gaye B, Tafflet M, Thomas F, Guibout C, Perier MC, Pannier B, Jouven X, Empana JP. Sex disparities in ideal cardiovascular health. Heart. 2017 Oct;103(20):1595-1601. doi: 10.1136/heartjnl-2017-311311. Epub 2017 Jul 28.
- Empana JP, Perier MC, Singh-Manoux A, Gaye B, Thomas F, Prugger C, Plichart M, Wiernik E, Guibout C, Lemogne C, Pannier B, Boutouyrie P, Jouven X. Cross-sectional analysis of deprivation and ideal cardiovascular health in the Paris Prospective Study 3. Heart. 2016 Dec 1;102(23):1890-1897. doi: 10.1136/heartjnl-2016-309502. Epub 2016 Jun 27.
- Alanis GA, Boutouyrie P, Abouqateb M, Bruno RM, Andrieu M, Vedie B, Geromin D, Danchin N, Laurent S, Jouven X, Empana JP. Accelerated Vascular Aging as a Possible Mechanism of Troponin I Release in the Absence of Clinically Manifested Myocardial Injury. J Am Heart Assoc. 2025 Apr;14(7):e037718. doi: 10.1161/JAHA.124.037718. Epub 2025 Mar 27.
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
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Death
- Pathological Conditions, Signs and Symptoms
- Cardiovascular Diseases
- Death, Sudden
- Investigative Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Techniques, Respiratory System
- Diagnostic Techniques, Cardiovascular
- Heart Function Tests
- Respiratory Function Tests
- Ergometry
- Exercise Test
Other Study ID Numbers
- C07-39
- 2007-A01386-47 (Registry Identifier: IDRCB)
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.