Cardiovascular Risk and Chronic Obstructive Pulmonary Disease

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT03014609
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-05
• Study Start: 2017-01-09
• Study First Posted: 2017-01-09
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-23
• Primary Completion: 2029-11
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Monitoring of COPD exacerbations compared to evolution of PWV	During 5 years since inclusion	Determination of the relationship between exacerbations and the evolution of the PWV.
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 visit	Measurement of sleep disorders and Sleep Apnea Syndrome
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).

Trial Locations

Locations (1)

University Grenoble Hospital; 🇫🇷 Grenoble, La Tronche, France