Understanding cardiovascular risk in COPD patients
Cardiovascular Risk and Chronic Obstructive Pulmonary Disease (COPD)
University Hospital, Grenoble · NCT03014609
This study looks at how inflammation and other factors in people with COPD might affect their heart health over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Grenoble (other) |
| Locations | 1 site (Grenoble, La Tronche) |
| Trial ID | NCT03014609 on ClinicalTrials.gov |
What this trial studies
This observational study aims to measure inflammation, oxidative stress, and various functional parameters in patients with chronic obstructive pulmonary disease (COPD) to identify indicators of cardiovascular risk. The study will follow a cohort of COPD patients over five years, combining data from an existing group and a new group of patients. By analyzing these parameters, the researchers hope to gain insights into the relationship between COPD and cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 18 to 85 with stable or decompensated COPD.
Not a fit: Patients with evolving infections, significant cardiac issues, or those on specific antioxidants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cardiovascular risks in COPD patients.
How similar studies have performed: While this study builds on existing knowledge, it employs a novel approach by integrating multiple parameters over an extended follow-up period.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Grenoble, La Tronche
- University Grenoble Hospital — Grenoble, La Tronche, France (RECRUITING)
Study contacts
- Principal investigator: Jean-Louis PEPIN, ProfessorPHD — University Grenoble Hospital
- Study coordinator: Jean-Louis PEPIN, ProfessorPHD
- Email: JPepin@chu-grenoble.fr
- Phone: +33 476 768 473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Obstructive Pulmonary Disease, chronic obstructive pulmonary disease, cardiovascular risk, inflammation, oxidative stress, peripheral muscle function