An observational study in Heart Failure, sponsored by Hospital Universitari de Bellvitge. Status unknown at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-13.
Sponsored by Hospital Universitari de Bellvitge · Observational
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 210 is close to the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Hospital Universitari de Bellvitge is the lead sponsor of 118 studies on the registry; 29 are open to participants now.
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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.
Exclusion Criteria:
Drug: Iron Carboxymaltose
Iron supplementation when is needed according to usual care
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.
Time frame: Twelve months after inclusion the patient
Functional Biomarkers (New York Heart Association [NYHA)
Comparison between ID and non ID patients
Time frame: 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
Time frame: Twelve months after inclusion the patient
Patient-reported experience measures (PREMs) (IEXPAC)
Comparison between ID and non ID patients
Time frame: Twelve months after inclusion the patient
Prognostic biomarkers (NT-proBNP)
Comparison between ID and non ID patients
Time frame: 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
Time frame: Twelve months after inclusion the patient
Functional Biomarkers (6-minutes walking test [6MWT] distance)
Comparison between ID and non ID patients
Time frame: Twelve months after inclusion the patient
Improvement of quality of life using a validated questionnaire (EUROQOL - 5D)
Comparison between ID and non ID patients
Time frame: Twelve months after inclusion the patient
Plan to share: No
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This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Hospital Universitari de Bellvitge