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NCT03014609 | RECRUITING | Chronic Obstructive Pulmonary Disease

Cardiovascular Risk and Chronic Obstructive Pulmonary Disease
Sponsor:

University Hospital, Grenoble

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.

Condition or disease

Chronic Obstructive Pulmonary Disease

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 150 participants
Official Title : Cardiovascular Risk and Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date : 2017-01-09
Estimated Primary Completion Date : 2029-11
Estimated Study Completion Date : 2029-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Cardiovascular Risk and Chronic Obstructive Pulmonary Disease

Location Details

NCT03014609

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How to Participate

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Locations

RECRUITING

France, La Tronche

University Grenoble Hospital

Grenoble, La Tronche, France, 38700