Heart FailureIRON-PATH IINCT05000853
New Pathophysiological Pathways Involved in Iron Metabolism Disorder in Heart Failure
An observational study of Heart Failure, run by Hospital Universitari de Bellvitge at 2 sites in Spain.
Trial summary
The aim of our study is to understand the biological pathways involved in the occurrence of IDy in patients with HF since ID is very common and supposes a negative impact in terms of clinical outcomes in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Iron Carboxymaltose
- How many people
- 210 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Aug 2021to 1 Aug 2023
- How long will I take part?
- 12 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study cohort will be a multicenter, observational, prospective, cross-sectional and longitudinal nested case-control sample of 210 patients with (130 cases) and without (80 controls) ID according to the FAIR-HF (27) (serum ferritin <100 mg/L or transferrin saturation [%TSAT]<20% if ferritin is between 100-300mg/L), recruited for the specific purpose of the IRON-PATH II study.
Who may be able to join
- Age ≥ 18 years old.
- HF diagnosis according to European Society of Cardiology
- LVEF≤50% (systolic HF).
- Patients receiving oral standard medication for chronic HF.
- Iron status evaluated in the last 3 months.
- Written informed consent.
Who cannot join
- Age<18 years old.
- Intravenous or oral iron administration or under treatment with ESA (erythropoiesis-stimulating agents) in the previous 3 months.
- Planned cardiac resynchronization therapy (CRT), revascularization and other major interventions including heart transplant or left ventricular assist device (LVAD) implantation in the next 3 months in patients with ID.
- Planned uptitration of guideline-mandatory HF-modifying drugs in the next 3 months (except iron repletion) in patients with ID.
- Moderate or severe anaemia (Hb<11 g/dL).
- The patient is unable or unwilling to give the informed consent to participate.
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- Unstable patients with signs of fluid overload or low cardiac output at the moment of enrollment.
- Life expectancy less than 1 year (excluding HF).
- The patient is considered not to be an adequate candidate for this study according to the decision of the local investigator.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitari de Bellvtige
L'Hospitalet de Llobregat, Barcelona, 08907
Josep R Comin, MD, PhD, +34-933-35-70-11 ext. 2274, jcomin@bellvitgehospital.cat
Maria del Mar Ras Jimenez, MD, +34-933-35-70-11 ext. 2274, mras@bellvitgehospital.cat
- Recruiting
University Hospital Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Josep Comín Colet, MD, PhD
About this study
Official title: New Pathophysiological Pathways Involved in Iron Metabolism Disorder in Heart Failure: The IRON-PATH II Investigator Initiated Study
The aim of our study is to understand the biological pathways involved in the occurrence of IDy in patients with HF since ID is very common and supposes a negative impact in terms of clinical outcomes in these patients. In this context, a deeper understanding of the mechanisms involved in the development of ID in these patients and the impact on the altered biological pathways after iron replenishment will pave the way for an improvement and simplification of the preventive strategies in patients with HF.
Read the detailed description
The IRON-PATH II Project is a pre-clinical and clinical study designed as a multicenter, prospective, observational (non-interventional), investigator initiated study. The total number of patients to be recruited will be 210 (80 patients without ID and 130 patients with ID). Patients will be recruited during 12 months in 7 centers across Spain and Portugal and followed for a fixed period of 12 months. The primary objective of the clinical study is to define pathways associated with systemic and tissue ID in HF patients compared with non-ID HF patients and explore the change in the patterns of pathway activation/suppression after irons status normalization in ID patients with intravenous iron treatment using an integrative omics and systems biology approach including whole-genome analysis of gene expression (transcriptome), protein synthesis (proteomics) and metabolic characterization (metabolomics) from blood samples. Key secondary objectives will include changes in patient-reported outcomes (PROMs) such as QoL, patient-reported experience measures (PREMs), the occurrence of events, among others between those with and without ID. The aims of the pre-clinical study is to confirm previous findings of the IRONPATH I study and to explore in vitro interventions in cardiac cells models with iron deficiency.
- Conditions
- Heart Failure
- Being tested
- Iron Carboxymaltose
- Keywords
- Iron Deficiency, Machine Learning, Multi-Omics Approaches, Outcomes Research
- Medical subject headings
- Heart Failure, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron CarboxymaltoseDrug
Iron supplementation when is needed according to usual care
| Study group | Role | What they receive |
|---|---|---|
| Patients with iron deficiency | Not described Receives: Drug: Iron Carboxymaltose | |
| Patients without iron deficiency | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define pathways associated with iron deficiency (ID) in heart failure (HF) patients compared with non-ID HF patients
Using an integrative omics and systems biology approach including whole-genome analysis of gene expression (transcriptome), protein synthesis (proteomics) and metabolic characterization (metabolomics) from blood samples.
Measured: Twelve months after inclusion the patient
Secondary outcomes (7)
Functional Biomarkers (New York Heart Association [NYHA)
Comparison between ID and non ID patients
Measured: Twelve months after inclusion the patient
Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale).
Comparison between ID and non ID patients
Measured: Twelve months after inclusion the patient
Patient-reported experience measures (PREMs) (IEXPAC)
Comparison between ID and non ID patients
Measured: Twelve months after inclusion the patient
Prognostic biomarkers (NT-proBNP)
Comparison between ID and non ID patients
Measured: Twelve months after inclusion the patient
Occurrence of events (all-cause death, HF-clinically related admissions, CV admissions)
Comparison between ID and non ID patients
Measured: Twelve months after inclusion the patient
Functional Biomarkers (6-minutes walking test [6MWT] distance)
Comparison between ID and non ID patients
Measured: Twelve months after inclusion the patient
Improvement of quality of life using a validated questionnaire (EUROQOL - 5D)
Comparison between ID and non ID patients
Measured: Twelve months after inclusion the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Aug 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Prospective
- Enrolment
- 210 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Comín, Hospital Universitari de Bellvitge
- Investigators
- Josep Comin Colet, MD, PhD, Principal investigator, Bellvitge Biomedical Research Institute (IDIBELL) - Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000853
- Sponsor's protocol ID
- IDIBELL - EOM019/21
- Acronym
- IRON-PATH II
- Status last verified
- Dec 2022
- First submitted
- 15 Jul 2021
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Pathophysiological Pathways Involved in Iron Metabolism Disorder in Heart Failure: The IRON-PATH II Investigator Initiated Study
- ClinicalTrials.gov ID
- NCT05000853
- Acronym / sponsor ID
- IRON-PATH II / IDIBELL - EOM019/21
- Conditions
- Heart Failure
- Keywords
- Iron Deficiency, Machine Learning, Multi-Omics Approaches, Outcomes Research
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 11 Aug 2021 (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.
The aim of our study is to understand the biological pathways involved in the occurrence of IDy in patients with HF since ID is very common and supposes a negative impact in terms of clinical outcomes in these patients. In this context, a deeper understanding of the mechanisms involved in the development of ID in these patients and the impact on the altered biological pathways after iron replenishment will pave the way for an improvement and simplification of the preventive strategies in patients with HF.
Detailed description
The IRON-PATH II Project is a pre-clinical and clinical study designed as a multicenter, prospective, observational (non-interventional), investigator initiated study. The total number of patients to be recruited will be 210 (80 patients without ID and 130 patients with ID). Patients will be recruited during 12 months in 7 centers across Spain and Portugal and followed for a fixed period of 12 months. The primary objective of the clinical study is to define pathways associated with systemic and tissue ID in HF patients compared with non-ID HF patients and explore the change in the patterns of pathway activation/suppression after irons status normalization in ID patients with intravenous iron treatment using an integrative omics and systems biology approach including whole-genome analysis of gene expression (transcriptome), protein synthesis (proteomics) and metabolic characterization (metabolomics) from blood samples. Key secondary objectives will include changes in patient-reported outcomes (PROMs) such as QoL, patient-reported experience measures (PREMs), the occurrence of events, among others between those with and without ID. The aims of the pre-clinical study is to confirm previous findings of the IRONPATH I study and to explore in vitro interventions in cardiac cells models with iron deficiency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with iron deficiency | – | Drug: Iron Carboxymaltose |
| Patients without iron deficiency | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study cohort will be a multicenter, observational, prospective, cross-sectional and longitudinal nested case-control sample of 210 patients with (130 cases) and without (80 controls) ID according to the FAIR-HF (27) (serum ferritin <100 mg/L or transferrin saturation [%TSAT]<20% if ferritin is between 100-300mg/L), recruited for the specific purpose of the IRON-PATH II study.
Key inclusion criteria (6 listed)
- Age ≥ 18 years old.
- HF diagnosis according to European Society of Cardiology
- LVEF≤50% (systolic HF).
- Patients receiving oral standard medication for chronic HF.
- Iron status evaluated in the last 3 months.
Key exclusion criteria (9 listed)
- Age<18 years old.
- Intravenous or oral iron administration or under treatment with ESA (erythropoiesis-stimulating agents) in the previous 3 months.
- Planned cardiac resynchronization therapy (CRT), revascularization and other major interventions including heart transplant or left ventricular assist device (LVAD) implantation in the next 3 months in patients with ID.
- Planned uptitration of guideline-mandatory HF-modifying drugs in the next 3 months (except iron repletion) in patients with ID.
- Moderate or severe anaemia (Hb<11 g/dL).
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 |
|---|---|---|
| Iron CarboxymaltoseIron supplementation when is needed according to usual care | Drug | Patients with iron deficiency |
Primary outcome
To define pathways associated with iron deficiency (ID) in heart failure (HF) patients compared with non-ID HF patients
Time frame: Twelve months after inclusion the patient
Using an integrative omics and systems biology approach including whole-genome analysis of gene expression (transcriptome), protein synthesis (proteomics) and metabolic characterization (metabolomics) from blood samples.
7 secondary outcomes
Functional Biomarkers (New York Heart Association [NYHA)
Time frame: Twelve months after inclusion the patient
Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale).
Time frame: Twelve months after inclusion the patient
Patient-reported experience measures (PREMs) (IEXPAC)
Time frame: Twelve months after inclusion the patient
Prognostic biomarkers (NT-proBNP)
Time frame: Twelve months after inclusion the patient
Occurrence of events (all-cause death, HF-clinically related admissions, CV admissions)
Time frame: Twelve months after inclusion the patient
Functional Biomarkers (6-minutes walking test [6MWT] distance)
Time frame: Twelve months after inclusion the patient
Improvement of quality of life using a validated questionnaire (EUROQOL - 5D)
Time frame: Twelve months after inclusion the patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- 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.
Josep Comin Colet, MD, PhD principal investigator
Bellvitge Biomedical Research Institute (IDIBELL) - Hospital Universitari de Bellvitge
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Hospital Universitari de Bellvitge at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. 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 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Josep Comin Colet, MD, PhD (+34 932607078, jcomin@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define pathways associated with iron deficiency (ID) in heart failure (HF) patients compared with non-ID HF patients (time frame: Twelve months after inclusion the patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.