Clinical trial NCT00741728: Heart Rate, Baroreflex Sensitivity and Cardiovascular Morbidity and Mortality in the Population
Official title: Heart Rate, Baroreflex Sensitivity and Cardiovascular Morbidity and Mortality in the Population. The Paris Prospective Study III
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Community Based Study
Cardiovascular Disease
Sudden Death
Blood Pressure
Keywords: epidemiology
risk factors
heart rate
baroreflex sensitivity
sudden death
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2008-08-26
Enrollment: 10157
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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 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.

Eligibility 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.

Primary outcomes:
measure: cardiovascular disease (CVD)
timeFrame: through study completion, an average of 24 years
Secondary outcomes:
measure: heart rate parameters and baroreflex sensitivity
timeFrame: 4 Years
measure: other CVD outcomes
timeFrame: through study completion, an average of 24 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Investigations Pré cliniques et Preventives de Paris
Study officials:
affiliation: INSERM and APHP
name: Xavier Jouven, MD, PhD
role: STUDY_DIRECTOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Jean-Philippe Empana, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: INSERM and APHP
name: Pierre Boutouyrie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.