Changes in Myocardial Iron After Iron Administration
Status:
Completed
Trial end date:
2018-07-30
Target enrollment:
Participant gender:
Summary
Recent studies have shown that treatment with intravenous iron in patients with iron
deficiency (ID) and heart failure with reduced ejection fraction (HFrEF) improves
symptomatology, functional capacity, quality of life, and decreases hospitalizations
regardless of anemia. In addition, a decrease in myocardial iron content has been observed in
patients with chronic HFrEF. This preliminary evidence has led to postulate that myocardial
iron deficiency could play a direct role in the pathogenesis and progression of the disease.
The investigators hypothesize that the repletion of myocardial iron would explain part of the
benefit of this treatment. Thus, the investigators postulate that cardiac magnetic resonance
(CMR) (T2* and T1-mapping sequences) will be sensible enough to detect changes in myocardial
iron content as a result of intravenous iron administration, and that such changes will
correlate with simultaneous changes in parameters of heart failure severity.
In this double-blind 1:1 randomized study controlled by placebo the investigators aim to
determine the changes in myocardial iron content after treatment with intravenous ferric
carboxymaltose (FCM) by CMR at 7 and 30 days in patients with stable HFrEF and ID.
Phase:
Phase 4
Details
Lead Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia