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Recruiting Observational

Cardiovascular Risk and Chronic Obstructive Pulmonary Disease

NCT03014609 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2017-01-09
Last updated
2023-05-23

Condition(s) studied

Chronic Obstructive Pulmonary Disease

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

  • 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).

Trial sites (1)

FacilityCityRegionStatus
University Grenoble Hospital Grenoble La Tronche Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03014609 on ClinicalTrials.gov ↗ ← All trials in France