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Cardiovascular Risk and Chronic Obstructive Pulmonary Disease

Cardiovascular Risk and Chronic Obstructive Pulmonary Disease (COPD)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03014609
Acronym
ECO-COPD
Enrollment
150
Registered
2017-01-09
Start date
2017-01-09
Completion date
2029-12-31
Last updated
2023-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease, cardiovascular risk, inflammation, oxidative stress, peripheral muscle function

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.

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.

Interventions

None listed

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of the pulse wave velocity (PWV)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

MeasureTime frameDescription
Monitoring of COPD exacerbations compared to evolution of PWVDuring 5 years since inclusionDetermination of the relationship between exacerbations and the evolution of the PWV.
Relationship between the new cardiovascular (CV) events and the evolution of the PWV.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).
Correlations between the parameters of severity of pulmonary disease and physical activity.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.
Prevalence of nocturnal non-dipping of blood pressure during COPD.During 5 years since inclusion (once a year)Measurement of ambulatory arterial blood pressure during 24 hours
Impact of sleep disorders and sleep apnea syndrome on the evolution of CVR during COPD.At inclusion visitMeasurement of sleep disorders and Sleep Apnea Syndrome

Countries

France

Contacts

Primary ContactJean-Louis PEPIN, ProfessorPHD
JPepin@chu-grenoble.fr+33 476 768 473
Backup ContactSandrine BOUZON, CRA
SBouzon@chu-grenoble.fr+33 476 767 244

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026