Chronic Obstructive Pulmonary Disease
Conditions
Keywords
chronic obstructive pulmonary disease, cardiovascular risk, inflammation, oxidative stress, peripheral muscle function
Brief summary
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
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.
Interventions
None listed
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the pulse wave velocity (PWV) | During 5 years since inclusion (once a year) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monitoring of COPD exacerbations compared to evolution of PWV | During 5 years since inclusion | Determination of the relationship between exacerbations and the evolution of the PWV. |
| Relationship between the new cardiovascular (CV) events and the evolution of the PWV. | During 5 years since inclusion (once a year) | 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). |
| Correlations between the parameters of severity of pulmonary disease and physical activity. | During 5 years since inclusion (once a year) | Measurement of extent of pulmonary disease; exploration of peripheral muscle function; measurement of physical activity; measurements of endothelial function; measurement of cardiac function. |
| Prevalence of nocturnal non-dipping of blood pressure during COPD. | During 5 years since inclusion (once a year) | Measurement of ambulatory arterial blood pressure during 24 hours |
| Impact of sleep disorders and sleep apnea syndrome on the evolution of CVR during COPD. | At inclusion visit | Measurement of sleep disorders and Sleep Apnea Syndrome |
Countries
France