Cardiovascular Risk and Chronic Obstructive Pulmonary Disease (ECO-COPD)
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|ClinicalTrials.gov Identifier: NCT03014609|
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : October 16, 2018
|Condition or disease|
|Chronic Obstructive Pulmonary Disease|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||150 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Cardiovascular Risk and Chronic Obstructive Pulmonary Disease (COPD)|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||December 2025|
- Change of the pulse wave velocity (PWV) [ Time Frame: 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).
- Monitoring of COPD exacerbations compared to evolution of PWV [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: At inclusion visit ]Measurement of sleep disorders and Sleep Apnea Syndrome
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014609
|Contact: Jean-Louis PEPIN, ProfessorPHD||+33 476 768 473||JPepin@chu-grenoble.fr|
|Contact: Sandrine BOUZON, CRA||+33 476 767 244||SBouzon@chu-grenoble.fr|
|University Grenoble Hospital||Recruiting|
|Grenoble, La Tronche, France, 38700|
|Contact: Jean-Louis PEPIN, ProfessorPhD +33 476 768 473 JPepin@chu-grenoble.fr|
|Contact: Sandrine BOUZON, CRA +33 476 767 244 SBouzon@chu-grenoble.fr|
|Sub-Investigator: Renaud TAMISIER, ProfessorPhD|
|Sub-Investigator: Patrick LEVY, ProfessorPhD|
|Sub-Investigator: Cécile BOSC, MD|
|Sub-Investigator: Marie DESTORS, MD|
|Sub-Investigator: Sam BAYAT, MD|
|Sub-Investigator: Stéphane DOUTRELEAU, MD|
|Sub-Investigator: Bernard WUYAM, MD|
|Sub-Investigator: François ARBIB, MD|
|Sub-Investigator: Damien VIGLINO, MD|
|Sub-Investigator: Nicolas TERZI, ProfessorPhD|
|Sub-Investigator: Gilles BARONE-ROCHETTE, ProfessorPhD|
|Sub-Investigator: Patrice FAURE, ProfessorPhD|
|Sub-Investigator: Gilbert FERRETTI, ProfessorPhD|
|Principal Investigator:||Jean-Louis PEPIN, ProfessorPHD||University Grenoble Hospital|