Ferric Carboximaltose on Intra-myocardial Iron Load in Patients With Heart Failure

Summary

In general, anemia is associated with a greater presence of HF symptoms, worsening NYHA functional class, higher rate of hospitalization for heart failure, and reduced survival. However, it is unclear whether anemia is the cause of decreased survival or a marker for more advanced disease. Correction of iron deficiency in patients with New York Heart Association (NYHA) class II or III HF using intravenous iron (Ferinject®) improved "overall patient self-assessment" and NYHA functional class of 6-minute walk and health-related quality of life) in the FAIR-HF trial.

It is unknown if iron deficiency is correlated with intra-myocardial iron load as assessed by cardiac magnetic resonance (CMR) and if the treatment with intravenous iron has any impact on intra-myocardial iron load and left ventricular function.

The aim of the present study is to evaluate the effect of intravenous iron replacement on intra-myocardial iron deposits and the effect on left ventricular function.

Because it is a pilot study with few data in the literature, it is planned to use an initial sample of 20 patients.

We aim to evaluate the global ventricular function, the iron load by the T2 \* method, the cardiac strain, the "Fiddle" and the "Fat water" of each patient by CMR. After this examination, patients will undergo intravenous infusion of 1g of Ferric Carboxymaltose (Ferinject®).

A comparative analysis of the ejection fraction values at the beginning and at the end of the study by CMR will be performed, in addition to a clinical reassessment.

The inclusion criteria will be: Patients older than 18 years, with iron deficiency and reduced ejection fraction defined as: serum ferritin \<100 μg / L or with ferritin 100-299 μg / L with transferrin saturation \<20 %; Hemoglobin \<12g / dL in women and \<13g / dL in men; Clinical stability in the last 3 months; Left ventricular ejection fraction (LVEF) \<40% assessed by transthoracic echocardiography or CMR in the last 3 months. The exclusion criteria will be: patients with preserved ejection fraction (\> 50%), pregnant women, refusal to participate in the present study, implantable pacemaker or implantable defibrillator incompatible with MRI, cerebral cerebral aneurysm clip and/or intracerebral or intraocular metal fragments, electronic cochlear implants, patients with claustrophobia, patients with clinical or hemodynamic instability and patients with indication for blood transfusion (Hb ≤ 7g / dL).

Conditions

• Cardiac Failure
• Systolic Heart Failure
• Heart Failure, Systolic

Interventions

DRUG

Ferric carboxymaltose

Administration of Ferric Carboxymaltose intravenously, one dose only.

Sponsors & Collaborators

• Takeda

  collaborator INDUSTRY

• Hospital Moinhos de Vento

  lead OTHER

Principal Investigators

• Luis Beck da Silva, MD ScD · Hospital Moinhos de Vento

• Luciano Giordani, MD · Hospital Moinhos de Vento

• Carisi A Polanczyk, MD ScD · Hospital Moinhos de Vento

• Paulo R Schvartzman, MD ScD · Hospital Moinhos de Vento

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-30

Primary Completion

2020-12-31

Completion

2021-02-28

FDA Drug

Yes

Countries

• Brazil

Study Locations