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

Cardiovascular Disease Clinical Trial

— PPSIII  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00741728
• Other study ID #: C07-39
• Secondary ID: 2007-A01386-47
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2008
• Last updated: December 8, 2011
• Start date: June 2008
• Est. completion date: December 2019

Study information

• Verified date: December 2011
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Xavier Jouven, MD, PhD
• Phone: 1 56 09 36 87
• Email: xavier.jouven[@]egp.aphp.fr
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2019
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Disease
• Cardiovascular Diseases
• Community Based Study
• Death, Sudden
• Sudden Death

Intervention

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

Locations

Country	Name	City	State
France	Investigations Pré cliniques et Preventives de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View 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. Epub 2005 May 2. — View Citation

Jouven X, Empana JP, Schwartz PJ, Desnos M, Courbon D, Ducimetière P. Heart-rate profile during exercise as a predictor of sudden death. N Engl J Med. 2005 May 12;352(19):1951-8. — View Citation

Jouven X, Zureik M, Desnos M, Courbon D, Ducimetière P. Long-term outcome in asymptomatic men with exercise-induced premature ventricular depolarizations. N Engl J Med. 2000 Sep 21;343(12):826-33. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular disease		after 10 years of follow up	No
Secondary	heart rate parameters and baroreflex sensitivity		after 2 years of recruitment	No

External Links

•   official website of the French National Institute for Health and Medical Research