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

Active, not recruiting

• Conditions: Sudden Death; Cardiovascular Disease; Blood Pressure; Community Based Study
• Interventions: Other: Spider flash EKG, echocardiography tracking, step test

• Registration Number: NCT00741728
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Study Timeline

• Study Start: 2008-05-13
• Study First Submitted: 2008-08-25
• Study First Submitted QC: 2008-08-25
• Study First Posted: 2008-08-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-10
• Primary Completion: 2032-06
• Study Completion: 2032-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10157

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
general population	Spider flash EKG, echocardiography tracking, step test	Observational study of 10000 adult men and women from the general population who benefited from a free extensive health check up in Paris, France

Primary Outcome Measures

Name	Time	Method
cardiovascular disease (CVD)	through study completion, an average of 24 years	incident coronary heart disease (CHD), stroke, sudden death, mortality

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Investigations Pré cliniques et Preventives de Paris; 🇫🇷 Paris, France