Cardiovascular Risk and Chronic Obstructive Pulmonary Disease

NCT ID: NCT03014609

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-09
• Study Completion Date: 2029-12-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Louis PEPIN, ProfessorPHD

Role: PRINCIPAL_INVESTIGATOR

University Grenoble Hospital

Locations

University Grenoble Hospital

Grenoble, La Tronche, France

Site Status: RECRUITING

Countries

France

Central Contacts

Jean-Louis PEPIN, ProfessorPHD

Role: CONTACT

JPepin@chu-grenoble.fr

+33 476 768 473

Sandrine BOUZON, CRA

Role: CONTACT

SBouzon@chu-grenoble.fr

+33 476 767 244

Facility Contacts

Jean-Louis PEPIN, ProfessorPhD

Role: primary

JPepin@chu-grenoble.fr

+33 476 768 473

Sandrine BOUZON, CRA

Role: backup

SBouzon@chu-grenoble.fr

+33 476 767 244

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Other Identifiers

38RC16.245

Identifier Type: -

Identifier Source: org_study_id