Ferric Carboximaltose on Intra-myocardial Iron Load in Patients With Heart Failure
Status:
Unknown status
Trial end date:
2021-02-28
Target enrollment:
Participant gender:
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).