Cardiovascular Risk and Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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The principal objective of the study is to measure parameters of inflammation, oxidative stress, and vascular, respiratory, and peripheral muscle function parameters, and identify parameters indicative of evolving cardiovascular risk (CVR) in COPD patients, using multivariate analysis.

Detailed Description
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Reduced lung function is a major risk factor for cardiovascular mortality (CV), regardless of age, sex and history of smoking. Similarly, CV events are known causes of mortality in patients with chronic obstructive pulmonary disease (COPD). The investigators propose to determine the parameters influencing the evolution of CV risk in a cohort of COPD patients followed over 5 years. For this the investigators will study the role of inflammation, oxidative stress, and vascular, respiratory and peripheral muscle function parameters. In order to study a sufficient number of patients the investigators propose to group data from two cohorts: a first cohort of 121 COPD patients that already exists (currently closed to inclusions but still undergoing follow-up (NCT00404430)) and a new cohort of 150, decompensated or not, COPD patients. This study is of major scientific interest and will enable to obtain extremely important information to better understand COPD.

Official Title
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Cardiovascular Risk and Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Chronic Obstructive Pulmonary Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For patients with stable COPD: Men or women aged 18 to 85 FEV1/FVC < 70% or proven BPCO Patients who have given their free and informed consent in writing For patients with decompensated COPD: Men or women aged 18 to 85 FEV1/FVC < 70% or proven BPCO At the time of acute respiratory failure (ARF), when admitted to hospital: Respiratory rate > 25 cycles per minute PaCO2 > 45 mmHg blood pH < 7.35 When included in the study: pH > 7.33 at the end of ARF, 2 days in a row, or 3 to 7 days post-D1 decompensation (admission to the hospital) Fever < 38.5°C Patients who have given their free and informed consent in writing Exclusion Criteria: Obvious evolving infection or CRP > 100 mg/L Cardiac decompensation considered the main cause of decompensation or chronic heart failure with LVEF < 45% Evolving neoplasia On antioxidants: N-acetyl-cysteine, selenium, vit. C, vit. E Pregnant or nursing women Patients under tutorship or curatorship Patients participating in a drug clinical research study Patients not affiliated to the French social security system (or equivalent) Patients deprived of liberty or hospitalized without consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the pulse wave velocity (PWV) | Measurement of pulse wave velocity (PWV), which reflects cardiovascular risk (CVR). This measure will be performed at each visit (V1, V1 bis, V2, V3, V4, V5 and V6). | During 5 years since inclusion (once a year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring of COPD exacerbations compared to evolution of PWV | Determination of the relationship between exacerbations and the evolution of the PWV. | During 5 years since inclusion | 
| Relationship between the new cardiovascular (CV) events and the evolution of the PWV. | Follow-up of exacerbations compared to new CV events (including myocardial infarction with or without ST segment elevation, ischemic stroke, unexplained sudden death at 5 years). | During 5 years since inclusion (once a year) | 
| Correlations between the parameters of severity of pulmonary disease and physical activity. | Measurement of extent of pulmonary disease; exploration of peripheral muscle function; measurement of physical activity; measurements of endothelial function; measurement of cardiac function. | During 5 years since inclusion (once a year) | 
| Prevalence of nocturnal non-dipping of blood pressure during COPD. | Measurement of ambulatory arterial blood pressure during 24 hours | During 5 years since inclusion (once a year) | 
| Impact of sleep disorders and sleep apnea syndrome on the evolution of CVR during COPD. | Measurement of sleep disorders and Sleep Apnea Syndrome | At inclusion visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic obstructive pulmonary disease, cardiovascular risk, inflammation, oxidative stress, peripheral muscle function