Investigating iron metabolism and cell death in COPD patients

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

This study looks at how a type of cell death related to iron levels affects people with COPD and aims to see if it plays a role in worsening their condition.

Quick facts

• Study type: Observational
• Enrollment: 180 (estimated)
• Ages: 40 Years to 100 Years
• Sex: All
• Sponsor: Hospital Universitario Marqués de Valdecilla (Academic / other)
• Locations: 1 site (Santander, Cantabria)
• Trial ID: NCT06102993 on ClinicalTrials.gov

What this trial studies

This observational study examines the role of ferroptosis, a specific type of cell death linked to iron metabolism, in patients with chronic obstructive pulmonary disease (COPD). It aims to explore the biochemical and functional factors that contribute to COPD exacerbations, particularly focusing on the relationship between iron and lipid metabolism disorders. The study will include patients with stable COPD and those experiencing exacerbations, as well as a control group of smokers without COPD, to assess the implications of ferroptosis on disease progression and cardiovascular risks.

Who should consider this trial

Good fit: Ideal candidates include patients over 40 years old with stable COPD diagnosed according to Spanish guidelines, with or without cardiovascular risk factors.

Not a fit: Patients with severe chronic conditions unrelated to COPD or those without a history of smoking may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of COPD pathophysiology and lead to improved diagnostic and prognostic tools for patients.

How similar studies have performed: While the specific focus on ferroptosis in COPD is novel, related studies on iron metabolism and cell death have shown promising results in other contexts.

Eligibility criteria

Patients with stable phase COPD (not exacerbated) diagnosed according to GesePOC criteria (Spanish guidelines of COPD), over 40 years of age (patients with a history of smoking and forced spirometry after a BD test with a quotient of 0.7) will be included. These patients may or may not have clinical atherosclerosis with/without CCV risk factors and will be studied globally and in groups. The group of acute COPD will consist of patients who have been admitted to the pneumology service diagnosed with exacerbation of COPD syndrome. They must have been diagnosed with COPD according to the GesEPOC (Spanish guidelines of COPD) criteria prior to admission. The control group will consist of 30-40 active smoking volunteers or former smokers without COPD matched by age, level of smoking, without respiratory or renal diseases or serious chronic conditions (severe, known HF, malignant diseases in progression...). COPD will be ruled out by spirometry and the rest of

the pathology will be ruled out by means of a clinical interview and review of ancient history. Stable-phase COPD who have renal failure (Glomerular filtration estimated by the CDK-EPI formula of less than 60 ml/min/1.73 m2), stable phase COPD who have undergone respiratory rehabilitation for at least 6 months before entering the study, or COPD in a stable phase with other diseases or drugs that may cause alterations in the parameters studied (specifically: active tumor diseases, sepsis, critical situations from another origin) will be excluded. Although a group of patients with iron deficiency anemia or iron deficiency without anemia will be included, we do not expect MIFRP to have prognostic utility in this group, so patients with iron deficiency anemia will be excluded from the prospective part of the study, according to the work of Pérez-Peiró et al. (11).

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.

Where this trial is running

Santander, Cantabria

• Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain (Recruiting)

Study contacts

• Study coordinator: Carlos Amado, PhD

Conditions COPD Exacerbation