New Pathophysiological Pathways Involved in Iron Metabolism Disorder in Heart Failure

Heart Failure Clinical Trial

— IRON-PATH II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05000853
• Other study ID #: IDIBELL - EOM019/21
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: December 2022
• Source: Hospital Universitari de Bellvitge
• Contact: Josep Comin Colet, MD, PhD
• Phone: +34 932607078
• Email: jcomin[@]bellvitgehospital.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: August 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Heart Failure
• Iron Metabolism Disorders
• Metabolic Diseases

Intervention

Drug:
• Iron Carboxymaltose
Iron supplementation when is needed according to usual care

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvtige	Hospitalet de Llobregat	Barcelona
Spain	University Hospital Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Twelve months after inclusion the patient
Secondary	Functional Biomarkers (New York Heart Association [NYHA)	Comparison between ID and non ID patients	Twelve months after inclusion the patient
Secondary	Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale).	Comparison between ID and non ID patients	Twelve months after inclusion the patient
Secondary	Patient-reported experience measures (PREMs) (IEXPAC)	Comparison between ID and non ID patients	Twelve months after inclusion the patient
Secondary	Prognostic biomarkers (NT-proBNP)	Comparison between ID and non ID patients	Twelve months after inclusion the patient
Secondary	Occurrence of events (all-cause death, HF-clinically related admissions, CV admissions)	Comparison between ID and non ID patients	Twelve months after inclusion the patient
Secondary	Functional Biomarkers (6-minutes walking test [6MWT] distance)	Comparison between ID and non ID patients	Twelve months after inclusion the patient
Secondary	Improvement of quality of life using a validated questionnaire (EUROQOL - 5D)	Comparison between ID and non ID patients	Twelve months after inclusion the patient