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Trial record 5 of 443 for:    COPD | Recruiting, Not yet recruiting, Available Studies | "Pulmonary Disease, Chronic Obstructive"

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 : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
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 [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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

  5. 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
Serum and plasma samples will be collected for each patient at the inclusion visit and follow-up visits. Parameters of inflammation, cardiovascular risk, oxidative stress and metabolic function will be measured.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD Patients will be recruited during the consultations in Pneumology Department or in the Laboratory of Sleep (patients with stable COPD) or during their hospitalization in Medical Reanimation Unit (patients with decompensated COPD) at the University Grenoble Hospital.
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.

Information from the National Library of Medicine

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


Contacts
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

Locations
France
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         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Louis PEPIN, ProfessorPHD University Grenoble Hospital

Publications of Results:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03014609     History of Changes
Other Study ID Numbers: 38RC16.245
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by University Hospital, Grenoble:
chronic obstructive pulmonary disease
cardiovascular risk
inflammation
oxidative stress
peripheral muscle function

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases