IRON-PATH II: New Pathophysiological Pathways Involved in Iron Metabolism Disorder in Heart Failure

Sponsor

Hospital Universitari de Bellvitge (Other)

Overall Status

Recruiting

CT.gov ID

NCT05000853

Collaborator

(none)

210

Enrollment

Locations

Anticipated Duration (Months)

105

Patients Per Site

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: Iron Carboxymaltose

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

210 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients with iron deficiency	Drug: Iron Carboxymaltose Iron supplementation when is needed according to usual care
Patients without iron deficiency

Arm

Intervention/Treatment

Patients with iron deficiency

Drug: Iron Carboxymaltose

Iron supplementation when is needed according to usual care

Patients without iron deficiency

Outcome Measures

Primary Outcome Measures

To define pathways associated with iron deficiency (ID) in heart failure (HF) patients compared with non-ID HF patients [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitari de Bellvtige	Hospitalet de Llobregat	Barcelona	Spain	08907
2	University Hospital Bellvitge	L'Hospitalet de Llobregat	Barcelona	Spain	08907