Cardiovascular Risk and Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

— ECO-COPD  

Official title:

Cardiovascular Risk and Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03014609
• Other study ID #: 38RC16.245
• Status: Recruiting
• Start date: January 9, 2017
• Est. completion date: December 2029

Study information

• Verified date: May 2023
• Source: University Hospital, Grenoble
• Contact: Jean-Louis PEPIN, ProfessorPHD
• Phone: +33 476 768 473
• Email: JPepin[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2029
• Est. primary completion date: November 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
France	University Grenoble Hospital	Grenoble	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (29)

Barreiro 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/ — View Citation

Carter 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. — View Citation

de 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):9 — View Citation

Debigare 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. — View Citation

Dekhuijzen 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 — View Citation

Engelen 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: — View Citation

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. — View Citation

Gan WQ, Man SF, Sin DD. The interactions between cigarette smoking and reduced lung function on systemic inflammation. Chest. 2005 Feb;127(2):558-64. doi: 10.1378/chest.127.2.558. — View Citation

Heunks 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. — View Citation

Heunks 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 — View Citation

Hunninghake DB. Cardiovascular disease in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2005;2(1):44-9. doi: 10.1513/pats.200410-050SF. — View Citation

Labarere J, Renaud B, Fine MJ. How to derive and validate clinical prediction models for use in intensive care medicine. Intensive Care Med. 2014 Apr;40(4):513-27. doi: 10.1007/s00134-014-3227-6. Epub 2014 Feb 26. Erratum In: Intensive Care Med. 2014 Jun; — View Citation

Lerman A, Zeiher AM. Endothelial function: cardiac events. Circulation. 2005 Jan 25;111(3):363-8. doi: 10.1161/01.CIR.0000153339.27064.14. No abstract available. — View Citation

MacCallum PK. Markers of hemostasis and systemic inflammation in heart disease and atherosclerosis in smokers. Proc Am Thorac Soc. 2005;2(1):34-43. doi: 10.1513/pats.200406-036MS. — View Citation

Mador 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. — View Citation

Mallia 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. — View Citation

Malo 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. — View Citation

Marin JM, Soriano JB, Carrizo SJ, Boldova A, Celli BR. Outcomes in patients with chronic obstructive pulmonary disease and obstructive sleep apnea: the overlap syndrome. Am J Respir Crit Care Med. 2010 Aug 1;182(3):325-31. doi: 10.1164/rccm.200912-1869OC. — View Citation

Minet C, Vivodtzev I, Tamisier R, Arbib F, Wuyam B, Timsit JF, Monneret D, Borel JC, Baguet JP, Levy P, Pepin JL. Reduced six-minute walking distance, high fat-free-mass index and hypercapnia are associated with endothelial dysfunction in COPD. Respir Phy — View Citation

Patel AR, Kowlessar BS, Donaldson GC, Mackay AJ, Singh R, George SN, Garcha DS, Wedzicha JA, Hurst JR. Cardiovascular risk, myocardial injury, and exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 Nov 1;188(9):1091-9. — View Citation

Rahman 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. — View Citation

Rennard SI. Clinical approach to patients with chronic obstructive pulmonary disease and cardiovascular disease. Proc Am Thorac Soc. 2005;2(1):94-100. doi: 10.1513/pats.200410-051SF. — View Citation

Saey 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. do — View Citation

Vassilakopoulos T, Karatza MH, Katsaounou P, Kollintza A, Zakynthinos S, Roussos C. Antioxidants attenuate the plasma cytokine response to exercise in humans. J Appl Physiol (1985). 2003 Mar;94(3):1025-32. doi: 10.1152/japplphysiol.00735.2002. Epub 2002 N — View Citation

Vivodtzev I, Minet C, Tamisier R, Arbib F, Borel JC, Baguet JP, Levy P, Pepin JL. Arterial stiffness by pulse wave velocity in COPD: reliability and reproducibility. Eur Respir J. 2013 Oct;42(4):1140-2. doi: 10.1183/09031936.00014813. No abstract availabl — View Citation

Vivodtzev I, Minet C, Wuyam B, Borel JC, Vottero G, Monneret D, Baguet JP, Levy P, Pepin JL. Significant improvement in arterial stiffness after endurance training in patients with COPD. Chest. 2010 Mar;137(3):585-92. doi: 10.1378/chest.09-1437. Epub 2009 — View Citation

Vivodtzev I, Tamisier R, Baguet JP, Borel JC, Levy P, Pepin JL. Arterial stiffness in COPD. Chest. 2014 Apr;145(4):861-875. doi: 10.1378/chest.13-1809. — View Citation

Weidemann F, Herrmann S, Stork S, Niemann M, Frantz S, Lange V, Beer M, Gattenlohner S, Voelker W, Ertl G, Strotmann JM. Impact of myocardial fibrosis in patients with symptomatic severe aortic stenosis. Circulation. 2009 Aug 18;120(7):577-84. doi: 10.116 — View Citation

Yende 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 obstruct — View Citation

* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	During 5 years since inclusion (once a year)
Secondary	Monitoring of COPD exacerbations compared to evolution of PWV	Determination of the relationship between exacerbations and the evolution of the PWV.	During 5 years since inclusion
Secondary	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).	During 5 years since inclusion (once a year)
Secondary	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.	During 5 years since inclusion (once a year)
Secondary	Prevalence of nocturnal "non-dipping" of blood pressure during COPD.	Measurement of ambulatory arterial blood pressure during 24 hours	During 5 years since inclusion (once a year)
Secondary	Impact of sleep disorders and sleep apnea syndrome on the evolution of CVR during COPD.	Measurement of sleep disorders and Sleep Apnea Syndrome	At inclusion visit