Community Based StudyPPSIIINCT00741728
Heart Rate, Baroreflex Sensitivity and Cardiovascular Morbidity and Mortality in the Population
An observational study of Community Based Study and Cardiovascular Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Community Based Study, Cardiovascular Disease, Sudden Death
- What is being tested?
- Spider flash ECG, high-precision carotid echo-tracking, step test
- How many people
- 10,157 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2008to Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 50-75 years, French speaking, given consent for genetic analysis,
- written consent for participating in the study
Who cannot join
- <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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Spider flash ECG, high-precision carotid echo-tracking, step test
- Keywords
- epidemiology, risk factors, heart rate, baroreflex sensitivity, sudden death
- Medical subject headings
- Cardiovascular Diseases, Death, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spider flash ECG, high-precision carotid echo-tracking, step testOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Spider flash ECG, high-precision carotid echo-tracking, step test |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular disease (CVD)
incident coronary heart disease (CHD), stroke, sudden death, mortality
Measured: through study completion, an average of 24 years
Secondary outcomes (2)
heart rate parameters and baroreflex sensitivity
as measured on the Spider Flash ECG and the carotid echotracking
Measured: 4 Years
other CVD outcomes
heart failure, arterial aneurysms, venous thromboembolism (VTE), pulmonary embolism, arrhythmic events (atrial fibrillation, flutter)
Measured: through study completion, an average of 24 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study start13 May 2008
- Primary completionJun 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Community Based StudyStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,157 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xavier Jouven, MD, PhD, Study director, INSERM and APHPJean-Philippe Empana, MD, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, FrancePierre Boutouyrie, MD, PhD, Principal investigator, INSERM and APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741728
- Sponsor's protocol ID
- C07-39
- Other IDs
- 2007-A01386-47
- Acronym
- PPSIII
- Status last verified
- Feb 2026
- First submitted
- 25 Aug 2008
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 15888695Jouven 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.
PubMed 10995861Briet 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.
PubMed 16408126Kornet 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.
PubMed 15775787Empana 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.
PubMed 15867179Alanis 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.
PubMed 40145294Deraz 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.
PubMed 34875909Lisan 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.
PubMed 29593025Simon 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.
PubMed 28754808Empana 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.
PubMed 27354274
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate, Baroreflex Sensitivity and Cardiovascular Morbidity and Mortality in the Population. The Paris Prospective Study III
- ClinicalTrials.gov ID
- NCT00741728
- Acronym / sponsor ID
- PPSIII / C07-39
- Keywords
- epidemiology, risk factors, heart rate, baroreflex sensitivity, sudden death
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,157 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 13 May 2008 (actual)
- Primary completion
- Jun 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 26 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| general population | – | Other: Spider flash ECG, high-precision carotid echo-tracking, step testObservational study of 10157 adult men and women from the general population who benefited from a free extensive health check up in Paris, France |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 50-75 years, French speaking, given consent for genetic analysis,
- written consent for participating in the study
Key exclusion criteria (6 listed)
- <50 years and >75 years,
- no French speaking,
- current pregnancy,
- chronic severe disease,
- disagreement for genetic analysis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spider flash ECG, high-precision carotid echo-tracking, step testcardiac 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 | Other | general population |
Primary outcome
cardiovascular disease (CVD)
Time frame: through study completion, an average of 24 years
incident coronary heart disease (CHD), stroke, sudden death, mortality
2 secondary outcomes
heart rate parameters and baroreflex sensitivity
Time frame: 4 Years
other CVD outcomes
Time frame: through study completion, an average of 24 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Background: PubMed 15888695Jouven 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.
- Background: PubMed 10995861Jouven 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.
- Background: PubMed 16408126Briet 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.
- Background: PubMed 15775787Kornet 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.
- Background: PubMed 15867179Empana 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.
- Derived from this study: PubMed 40145294Alanis 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.
- Derived from this study: PubMed 34875909Deraz 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.
- Derived from this study: PubMed 29593025Lisan 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.
- Derived from this study: PubMed 28754808Simon 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.
- Derived from this study: PubMed 27354274Empana 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.
- official website of the French National Institute for Health and Medical ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Jouven, MD, PhD study director
INSERM and APHP
Jean-Philippe Empana, MD, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
Pierre Boutouyrie, MD, PhD principal investigator
INSERM and APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community Based Study and Cardiovascular Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular disease (CVD) (time frame: through study completion, an average of 24 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00741728, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.