New Pathophysiological Pathways Involved in Iron Metabolism Disorder in Heart Failure

NCT05000853 | Unknown DMC FDA Drug

• 1 other identifier: IDIBELL - EOM019/21
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Keywords

Iron Deficiency; Machine Learning; Multi-Omics Approaches; Outcomes Research

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Functional Biomarkers (New York Heart Association [NYHA)

  Twelve months after inclusion the patient

• Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale).

  Twelve months after inclusion the patient

• Patient-reported experience measures (PREMs) (IEXPAC)

  Twelve months after inclusion the patient

• Prognostic biomarkers (NT-proBNP)

  Twelve months after inclusion the patient

• Occurrence of events (all-cause death, HF-clinically related admissions, CV admissions)

  Twelve months after inclusion the patient

Study Arms (2)

Patients with iron deficiency

Drug: Iron Carboxymaltose

Patients without iron deficiency

Interventions

Iron Carboxymaltose DRUG

Iron supplementation when is needed according to usual care

Patients with iron deficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (2)

Hospital Universitari de Bellvtige

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

University Hospital Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

MeSH Terms

Conditions

Heart Failure; Iron Deficiencies

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Josep Comin Colet, MD, PhD

  Bellvitge Biomedical Research Institute (IDIBELL) - Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josep Comin Colet, MD, PhD

CONTACT

+34 932607078; jcomin@bellvitgehospital.cat

Maria del Mar Ras Jimenez, MD

CONTACT

+34 932607078; mras@bellvitgehospital.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Josep Comín-Colet, MD, PhD

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 11, 2021
• Study Start: August 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)