Ferroptosis in Patients With COPD COPD With/Without Risk of Cardiovascular Events. Pathophysiological Implications, Diagnostics and Prognoses. FerrEPOC Study.

NCT ID: NCT06102993

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-10-01

Brief Summary

Iron metabolism is related to several biochemical and functional factors that have a mayor impact in chronic obstructive pulmonary disease (COPD) such as hypoxia, hypercapnia, oxidative stress, chronic inflammation, cellular senescence, sarcopenia and ferroptosis. Ferroptosis is a specific form of cell death induced by excess intracellular free iron that generates lipid peroxidation of cell membranes, with subsequent cell death. The existence of excess ferroptosis in COPD due to tobacco smoke has been widely demonstrated in vitro both in respiratory tissue and in skeletal muscle. Iron and lipid metabolism disorders are an essential part of the pathogenesis of ferroptosis. These disorders have also been related to diseases that occur concomitantly with COPD, such as cardiovascular diseases. Recently, new genes related to iron metabolism that are involved in the development of ferroptosis have been identified. Proteins related with these genes have not been studied in vivo in the context of COPD and cardiovascular diseases. Some of them are purely intracellular in expression, but the expression of some of them can be measured in blood using methods available to any clinical laboratory. After an exhaustive study of the literature, we have selected a small group of circulating proteins expressed in DEGs (Differentially Expressed Genes) related to ferroptosis that overlap with the DEGs of COPD and the DEGs of atherosclerosis to evaluate the relationship between these molecules and clinical variables of COPD and their potential utility in identifying the risk of exacerbations, admissions, and cardiovascular events in COPD. This study could identify a trait in COPD useful for selecting patients at greater risk of exacerbation due to the relationship between ferroptosis and systemic inflammation and oxidative stress, cardiovascular risk and, in general, a worse prognosis of the disease. In addition, the identification of this trait can have important therapeutic implications.

Conditions

COPD Exacerbation

Study Design

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

Study Groups

COPD GOLD 1

Non-interventional study

Intervention Type: OTHER

The only intervention is to analyze serum molecules of patients with COPD and controls without COPD.

COPD GOLD 2

Non-interventional study

Intervention Type: OTHER

The only intervention is to analyze serum molecules of patients with COPD and controls without COPD.

COPD GOLD 3

Non-interventional study

Intervention Type: OTHER

The only intervention is to analyze serum molecules of patients with COPD and controls without COPD.

COPD GOLD 4

Non-interventional study

Intervention Type: OTHER

The only intervention is to analyze serum molecules of patients with COPD and controls without COPD.

Control group

Non-interventional study

Intervention Type: OTHER

The only intervention is to analyze serum molecules of patients with COPD and controls without COPD.

Exacerbated COPD

Non-interventional study

Intervention Type: OTHER

The only intervention is to analyze serum molecules of patients with COPD and controls without COPD.

Interventions

Non-interventional study

The only intervention is to analyze serum molecules of patients with COPD and controls without COPD.

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

Patients in the COPD group in the stable phase will be followed for one year in outpatient pneumology clinics. During the follow-up, all researchers related to the follow-up will not know the results of the blood samples. During this time, patients with respiratory exacerbation will go to the Emergency Department freely, and a team of doctors not related with the study will decide whether or not to hospitalize patients according to their own clinical criteria.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Marqués de Valdecilla

OTHER

Sponsor Role: lead

Responsible Party

Carlos Antonio Amado Diago

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Carlos Amado, PhD

Role: CONTACT

amadodiago.carlos@gmail.com

676235753

Cristina Ghadban

Role: CONTACT

942202520

Facility Contacts

Carlos Antonio Amado Diago, PhD

Role: primary

carlosantonio.amado@scsalud.es

0034676235753

Other Identifiers

2023.297

Identifier Type: -

Identifier Source: org_study_id