Chronic Obstructive Pulmonary DiseaseECO-COPDNCT03014609
Cardiovascular Risk and Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2017to Dec 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Grenoble Hospital
Grenoble, La Tronche, 38700
Jean-Louis PEPIN, ProfessorPhD, +33 476 768 473, JPepin@chu-grenoble.fr
Sandrine BOUZON, CRA, +33 476 767 244, SBouzon@chu-grenoble.fr
About this study
Official title: Cardiovascular Risk and Chronic Obstructive Pulmonary Disease (COPD)
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, cardiovascular risk, inflammation, oxidative stress, peripheral muscle function
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During 5 years since inclusion (once a year)
Secondary outcomes (5)
Monitoring of COPD exacerbations compared to evolution of PWV
Determination of the relationship between exacerbations and the evolution of the PWV.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: At inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start9 Jan 2017
- Primary completionNov 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis PEPIN, ProfessorPHD, Principal investigator, University Grenoble Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014609
- Sponsor's protocol ID
- 38RC16.245
- Acronym
- ECO-COPD
- Status last verified
- May 2023
- First submitted
- 4 Jan 2017
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gan WQ, Man SF, Senthilselvan A, Sin DD. Association between chronic obstructive pulmonary disease and systemic inflammation: a systematic review and a meta-analysis. Thorax. 2004 Jul;59(7):574-80. doi: 10.1136/thx.2003.019588.
PubMed 15223864Mallia P, Johnston SL. Mechanisms and experimental models of chronic obstructive pulmonary disease exacerbations. Proc Am Thorac Soc. 2005;2(4):361-6; discussion 371-2. doi: 10.1513/pats.200504-025SR.
PubMed 16267363de Torres JP, Cordoba-Lanus E, Lopez-Aguilar C, Muros de Fuentes M, Montejo de Garcini A, Aguirre-Jaime A, Celli BR, Casanova C. C-reactive protein levels and clinically important predictive outcomes in stable COPD patients. Eur Respir J. 2006 May;27(5):902-7. doi: 10.1183/09031936.06.00109605. Epub 2006 Feb 2.
PubMed 16455829Malo O, Sauleda J, Busquets X, Miralles C, Agusti AG, Noguera A. [Systemic inflammation during exacerbations of chronic obstructive pulmonary disease]. Arch Bronconeumol. 2002 Apr;38(4):172-6. Spanish.
PubMed 11953269Dekhuijzen PN, Aben KK, Dekker I, Aarts LP, Wielders PL, van Herwaarden CL, Bast A. Increased exhalation of hydrogen peroxide in patients with stable and unstable chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1996 Sep;154(3 Pt 1):813-6. doi: 10.1164/ajrccm.154.3.8810624.
PubMed 8810624Rahman I. The role of oxidative stress in the pathogenesis of COPD: implications for therapy. Treat Respir Med. 2005;4(3):175-200. doi: 10.2165/00151829-200504030-00003.
PubMed 15987234Heunks LM, Vina J, van Herwaarden CL, Folgering HT, Gimeno A, Dekhuijzen PN. Xanthine oxidase is involved in exercise-induced oxidative stress in chronic obstructive pulmonary disease. Am J Physiol. 1999 Dec;277(6):R1697-704. doi: 10.1152/ajpregu.1999.277.6.R1697.
PubMed 10600916Yende S, Waterer GW, Tolley EA, Newman AB, Bauer DC, Taaffe DR, Jensen R, Crapo R, Rubin S, Nevitt M, Simonsick EM, Satterfield S, Harris T, Kritchevsky SB. Inflammatory markers are associated with ventilatory limitation and muscle dysfunction in obstructive lung disease in well functioning elderly subjects. Thorax. 2006 Jan;61(1):10-6. doi: 10.1136/thx.2004.034181. Epub 2005 Nov 11.
PubMed 16284220Carter R, Holiday DB, Nwasuruba C, Stocks J, Grothues C, Tiep B. 6-minute walk work for assessment of functional capacity in patients with COPD. Chest. 2003 May;123(5):1408-15. doi: 10.1378/chest.123.5.1408.
PubMed 12740255Mador MJ, Kufel TJ, Pineda LA, Sharma GK. Diaphragmatic fatigue and high-intensity exercise in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2000 Jan;161(1):118-23. doi: 10.1164/ajrccm.161.1.9903010.
PubMed 10619807Saey D, Debigare R, LeBlanc P, Mador MJ, Cote CH, Jobin J, Maltais F. Contractile leg fatigue after cycle exercise: a factor limiting exercise in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2003 Aug 15;168(4):425-30. doi: 10.1164/rccm.200208-856OC. Epub 2003 Apr 24.
PubMed 12714348Engelen MP, Schols AM, Does JD, Wouters EF. Skeletal muscle weakness is associated with wasting of extremity fat-free mass but not with airflow obstruction in patients with chronic obstructive pulmonary disease. Am J Clin Nutr. 2000 Mar;71(3):733-8. doi: 10.1093/ajcn/71.3.733.
PubMed 10702166Barreiro E, de la Puente B, Minguella J, Corominas JM, Serrano S, Hussain SN, Gea J. Oxidative stress and respiratory muscle dysfunction in severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 May 15;171(10):1116-24. doi: 10.1164/rccm.200407-887OC. Epub 2005 Feb 25.
PubMed 15735057Debigare R, Cote CH, Maltais F. Peripheral muscle wasting in chronic obstructive pulmonary disease. Clinical relevance and mechanisms. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1712-7. doi: 10.1164/ajrccm.164.9.2104035. No abstract available.
PubMed 11719314Heunks LM, Dekhuijzen PN. Respiratory muscle function and free radicals: from cell to COPD. Thorax. 2000 Aug;55(8):704-16. doi: 10.1136/thorax.55.8.704. No abstract available.
PubMed 10899251
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk and Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT03014609
- Acronym / sponsor ID
- ECO-COPD / 38RC16.245
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, cardiovascular risk, inflammation, oxidative stress, peripheral muscle function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- Men or women aged 18 to 85
- FEV1/FVC < 70% or proven BPCO
- Patients who have given their free and informed consent in writing
- Men or women aged 18 to 85
- FEV1/FVC < 70% or proven BPCO
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
5 secondary outcomes
Monitoring of COPD exacerbations compared to evolution of PWV
Time frame: During 5 years since inclusion
Relationship between the new cardiovascular (CV) events and the evolution of the PWV.
Time frame: During 5 years since inclusion (once a year)
Correlations between the parameters of severity of pulmonary disease and physical activity.
Time frame: During 5 years since inclusion (once a year)
Prevalence of nocturnal "non-dipping" of blood pressure during COPD.
Time frame: During 5 years since inclusion (once a year)
Impact of sleep disorders and sleep apnea syndrome on the evolution of CVR during COPD.
Time frame: At inclusion visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Results publication: PubMed 15223864Gan WQ, Man SF, Senthilselvan A, Sin DD. Association between chronic obstructive pulmonary disease and systemic inflammation: a systematic review and a meta-analysis. Thorax. 2004 Jul;59(7):574-80. doi: 10.1136/thx.2003.019588.
- Results publication: PubMed 16267363Mallia P, Johnston SL. Mechanisms and experimental models of chronic obstructive pulmonary disease exacerbations. Proc Am Thorac Soc. 2005;2(4):361-6; discussion 371-2. doi: 10.1513/pats.200504-025SR.
- Results publication: PubMed 16455829de Torres JP, Cordoba-Lanus E, Lopez-Aguilar C, Muros de Fuentes M, Montejo de Garcini A, Aguirre-Jaime A, Celli BR, Casanova C. C-reactive protein levels and clinically important predictive outcomes in stable COPD patients. Eur Respir J. 2006 May;27(5):902-7. doi: 10.1183/09031936.06.00109605. Epub 2006 Feb 2.
- Results publication: PubMed 11953269Malo O, Sauleda J, Busquets X, Miralles C, Agusti AG, Noguera A. [Systemic inflammation during exacerbations of chronic obstructive pulmonary disease]. Arch Bronconeumol. 2002 Apr;38(4):172-6. Spanish.
- Results publication: PubMed 8810624Dekhuijzen PN, Aben KK, Dekker I, Aarts LP, Wielders PL, van Herwaarden CL, Bast A. Increased exhalation of hydrogen peroxide in patients with stable and unstable chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1996 Sep;154(3 Pt 1):813-6. doi: 10.1164/ajrccm.154.3.8810624.
- Results publication: PubMed 15987234Rahman I. The role of oxidative stress in the pathogenesis of COPD: implications for therapy. Treat Respir Med. 2005;4(3):175-200. doi: 10.2165/00151829-200504030-00003.
- Results publication: PubMed 10600916Heunks LM, Vina J, van Herwaarden CL, Folgering HT, Gimeno A, Dekhuijzen PN. Xanthine oxidase is involved in exercise-induced oxidative stress in chronic obstructive pulmonary disease. Am J Physiol. 1999 Dec;277(6):R1697-704. doi: 10.1152/ajpregu.1999.277.6.R1697.
- Results publication: PubMed 16284220Yende S, Waterer GW, Tolley EA, Newman AB, Bauer DC, Taaffe DR, Jensen R, Crapo R, Rubin S, Nevitt M, Simonsick EM, Satterfield S, Harris T, Kritchevsky SB. Inflammatory markers are associated with ventilatory limitation and muscle dysfunction in obstructive lung disease in well functioning elderly subjects. Thorax. 2006 Jan;61(1):10-6. doi: 10.1136/thx.2004.034181. Epub 2005 Nov 11.
- Results publication: PubMed 12740255Carter R, Holiday DB, Nwasuruba C, Stocks J, Grothues C, Tiep B. 6-minute walk work for assessment of functional capacity in patients with COPD. Chest. 2003 May;123(5):1408-15. doi: 10.1378/chest.123.5.1408.
- Results publication: PubMed 10619807Mador MJ, Kufel TJ, Pineda LA, Sharma GK. Diaphragmatic fatigue and high-intensity exercise in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2000 Jan;161(1):118-23. doi: 10.1164/ajrccm.161.1.9903010.
- Results publication: PubMed 12714348Saey D, Debigare R, LeBlanc P, Mador MJ, Cote CH, Jobin J, Maltais F. Contractile leg fatigue after cycle exercise: a factor limiting exercise in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2003 Aug 15;168(4):425-30. doi: 10.1164/rccm.200208-856OC. Epub 2003 Apr 24.
- Results publication: PubMed 10702166Engelen MP, Schols AM, Does JD, Wouters EF. Skeletal muscle weakness is associated with wasting of extremity fat-free mass but not with airflow obstruction in patients with chronic obstructive pulmonary disease. Am J Clin Nutr. 2000 Mar;71(3):733-8. doi: 10.1093/ajcn/71.3.733.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Louis PEPIN, ProfessorPHD principal investigator
University Grenoble Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Louis PEPIN, ProfessorPHD (+33 476 768 473, JPepin@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the pulse wave velocity (PWV) (time frame: During 5 years since inclusion (once a year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03014609, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.