NCT03398681

Changes in Myocardial Iron After Iron Administration

Changes in Myocardial Iron Content Following Administration of Intravenous Iron (Myocardial-IRON)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Iron-deficiency

Interventions

Type	Name	Description
DRUG	Ferric carboymaltose	Ferric Carboxymaltose solution \[Ferinject® (FCM), Vifor Pharma (Glattbrugg, Switzerland)\]
DRUG	Placebo (Normal saline)	Normal saline (0.9% weight/volume (w/v) NaCl)
DIAGNOSTIC_TEST	Cardiac magnetic resonance	Cardiac magnetic resonance including T2\* and T1-mapping sequences

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-07-30
• Completion: 2018-07-30
• First posted: 2018-01-12
• Last updated: 2019-07-30

Locations

6 sites across 1 country: Spain