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NCT Number: NCT03014609

Cardiovascular Risk and Chronic Obstructive Pulmonary Disease

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Grenoble Hospital

Grenoble, La Tronche, 38700, France

Location status: Recruiting

Location contact

Bernard WUYAM, MD

SUB_INVESTIGATOR

Cécile BOSC, MD

SUB_INVESTIGATOR

Damien VIGLINO, MD

SUB_INVESTIGATOR

François ARBIB, MD

SUB_INVESTIGATOR

Gilbert FERRETTI, ProfessorPhD

SUB_INVESTIGATOR

Gilles BARONE-ROCHETTE, ProfessorPhD

SUB_INVESTIGATOR

Jean-Louis PEPIN, ProfessorPhD

CONTACT

[email protected]

+33 476 768 473

Marie DESTORS, MD

SUB_INVESTIGATOR

Nicolas TERZI, ProfessorPhD

SUB_INVESTIGATOR

Patrice FAURE, ProfessorPhD

SUB_INVESTIGATOR

Patrick LEVY, ProfessorPhD

SUB_INVESTIGATOR

Renaud TAMISIER, ProfessorPhD

SUB_INVESTIGATOR

Sam BAYAT, MD

SUB_INVESTIGATOR

Sandrine BOUZON, CRA

CONTACT

[email protected]

+33 476 767 244

Stéphane DOUTRELEAU, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Louis PEPIN, ProfessorPHD

CONTACT

[email protected]

+33 476 768 473

Sandrine BOUZON, CRA

CONTACT

[email protected]

+33 476 767 244

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Cardiovascular Risk and Chronic Obstructive Pulmonary Disease (COPD)

Acronym: ECO-COPD

Important dates

Study start
2017
Primary completion
2029
Study completion
2029
First posted
Jan 9, 2017
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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