COPD ExacerbationFerrEPOCNCT06102993
Ferroptosis in Patients With COPD COPD With/Without Risk of Cardiovascular Events. Pathophysiological Implications, Diagnostics and Prognoses. FerrEPOC Study.
An observational study of COPD Exacerbation, run by Hospital Universitario Marqués de Valdecilla at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Non-interventional study
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2023to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- Adult, Older adult
Study population: Ambispective Observational Cohort Study to be carried out at the Marqués de Valdecilla University Hospital in Santander (Spain). Patients will be recruited successively among those who attend the outpatient clinic for COPD, smoking cessation in Pulmonology and among those who go to the Emergency Department and are going to be admitted due to an exacerbation of COPD.
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.
Trial locations and contacts
1 site in 1 country.
Cristina Ghadban contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39005
Carlos Antonio Amado Diago, PhD, 0034676235753, carlosantonio.amado@scsalud.es
About this study
Official title: Characterization of New Serum Biomarkers of Ferroptosis in Patients With COPD With/Without Risk of Cardiovascular Events. Pathophysiological Implications, Diagnostics and Prognoses. FerrEPOC Study
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
- Being tested
- Non-interventional study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional studyOther
The only intervention is to analyze serum molecules of patients with COPD and controls without COPD.
| Study group | Role | What they receive |
|---|---|---|
| COPD GOLD 1 | Not described Receives: Other: Non-interventional study | |
| COPD GOLD 2 | Not described Receives: Other: Non-interventional study | |
| COPD GOLD 3 | Not described Receives: Other: Non-interventional study | |
| COPD GOLD 4 | Not described Receives: Other: Non-interventional study | |
| Control group | Not described Receives: Other: Non-interventional study | |
| Exacerbated COPD | Not described Receives: Other: Non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to hospitalization
Measured: 1 year after entering the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Oct 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Antonio Amado Diago, Hospital Universitario Marqués de Valdecilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102993
- Sponsor's protocol ID
- 2023.297
- Acronym
- FerrEPOC
- Status last verified
- Oct 2023
- First submitted
- 21 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghadban C, Garcia-Unzueta M, Aguero J, Martin-Audera P, Lavin BA, Guerra AR, Berja A, Aranda N, Guzun A, Insua AI, Amado CA. Associations between serum levels of ferroptosis-related molecules and outcomes in stable COPD: an exploratory prospective observational study. Intern Emerg Med. 2025 Sep;20(6):1761-1773. doi: 10.1007/s11739-025-04016-z. Epub 2025 Jun 21.
PubMed 40542968
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of New Serum Biomarkers of Ferroptosis in Patients With COPD With/Without Risk of Cardiovascular Events. Pathophysiological Implications, Diagnostics and Prognoses. FerrEPOC Study
- ClinicalTrials.gov ID
- NCT06102993
- Acronym / sponsor ID
- FerrEPOC / 2023.297
- Conditions
- COPD Exacerbation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hospital Universitario Marqués de ValdecillaUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| COPD GOLD 1 | – | Other: Non-interventional study |
| COPD GOLD 2 | – | Other: Non-interventional study |
| COPD GOLD 3 | – | Other: Non-interventional study |
| COPD GOLD 4 | – | Other: Non-interventional study |
| Control group | – | Other: Non-interventional study |
| Exacerbated COPD | – | Other: Non-interventional study |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Ambispective Observational Cohort Study to be carried out at the Marqués de Valdecilla University Hospital in Santander (Spain). Patients will be recruited successively among those who attend the outpatient clinic for COPD, smoking cessation in Pulmonology and among those who go to the Emergency Department and are going to be admitted due to an exacerbation of COPD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional studyThe only intervention is to analyze serum molecules of patients with COPD and controls without COPD. | Other | COPD GOLD 1, COPD GOLD 2, COPD GOLD 3, COPD GOLD 4, Control group, Exacerbated COPD |
Primary outcome
Time to hospitalization
Time frame: 1 year after entering the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Derived from this study: PubMed 40542968Ghadban C, Garcia-Unzueta M, Aguero J, Martin-Audera P, Lavin BA, Guerra AR, Berja A, Aranda N, Guzun A, Insua AI, Amado CA. Associations between serum levels of ferroptosis-related molecules and outcomes in stable COPD: an exploratory prospective observational study. Intern Emerg Med. 2025 Sep;20(6):1761-1773. doi: 10.1007/s11739-025-04016-z. Epub 2025 Jun 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Ghadban contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation, run by Hospital Universitario Marqués de Valdecilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Amado, PhD (676235753, amadodiago.carlos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to hospitalization (time frame: 1 year after entering the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06102993, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.