Iron in Patients With Cardiovascular Disease (iCHF-2)
Cardiovascular Diseases, Anemia, Iron-deficiency, Acute Myocardial Infarction
About this trial
This is an interventional treatment trial for Cardiovascular Diseases focused on measuring Iron deficiency, Atrial fibrillation, Acute myocardial infarction, Systolic heart failure, Anemia
Eligibility Criteria
Inclusion Criteria:
- Cohort A (acute myocardial infarction): Acute Myocardial Infarction within 10 days (randomization/ first iron supplementation/ MRI must be performed within 10 days after AMI), without prior heart failure (defined as any known previous report of LVEF ≤ 45%) Cohort B (atrial fibrillation): Paroxysmal Atrial fibrillation or persistent AF Cohort C (heart failure): Left-ventricular ejection fraction ≤ 45 % (documented within the last 12 months prior to screening), all NYHA classes allowed
- Confirmed presence of iron deficiency (ferritin < 100 ng/mL or ferritin 100 - 299 ng/mL with transferrin saturation < 20 %)
- Haemoglobin ≤ 15.5 g/dL
- Written informed consent
Exclusion Criteria:
- Evidence of iron overload or disturbances in the utilisation of iron
- History of severe asthma, eczema or other atopic allergy
- History of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis)
- Use of renal replacement therapy
- Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 4 weeks prior to randomisation.
Sites / Locations
- University of Berlin, Campus Benjamin-Franklin
- University Heart Center HamburgRecruiting
- University of Ulm
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Intravenous iron
Placebo
Intravenous iron administration in the form of ferric carboxymaltose will be carried out according to summary of product characteristics. Bolus administration (1000 mg) will be followed by an optional administration of 500-1000 mg within the first 4 weeks (up to a total of 2000 mg which is in-label) according to approved dosing rules, followed by administration of 500 mg ferric carboxymaltose at months 4 and 8, except when haemoglobin is > 16.0 g/dL or ferritin is > 600 µg/L. To avoid unblinding in these patients a saline infusion will be administered.
Administration of i.v. NaCl according to the dosing rules for intravenous iron.