NCT05000853

New Pathophysiological Pathways Involved in Iron Metabolism Disorder in Heart Failure

New Pathophysiological Pathways Involved in Iron Metabolism Disorder in Heart Failure: The IRON-PATH II Investigator Initiated Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 210 (estimated)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Iron Carboxymaltose	Iron supplementation when is needed according to usual care

Timeline

• Start date: 2021-08-01
• Primary completion: 2023-07-01
• Completion: 2023-08-01
• First posted: 2021-08-11
• Last updated: 2022-12-13

Locations

2 sites across 1 country: Spain

Regulatory

• FDA-regulated drug study