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. 2019 Sep 28;6(6):1208–1215. doi: 10.1002/ehf2.12503

Table 1.

Major inclusion and exclusion criteria of the IRON‐CRT trial

Inclusion criteria

•Patients with chronic heart failure and implantation of cardiac resynchronization therapy more than 6 months ago and presence of iron deficiency (ferritin <100 μg/L, irrespective of TSAT or ferritine between 100 and 300 μg/L with TSAT < 20%) and presence of incomplete reverse remodelling (LVEF < 45%)

•Age ≥18 years

•Obtained informed consent

•Stable pharmacological therapy of heart failure during the last 4 weeks (with the exception of diuretics)

•At least 98% bivacing the last 6 months

Exclusion criteria

•A TSAT > 45%

•Haemoglobin >15 g/dL at inclusion

•Planned cardiovascular hospitalization during study period

•Known hypersensitivity to Injectafer®

•Known active infection, CRP > 20 mg/L, clinically significant bleeding, and active malignancy

•Chronic liver disease and/or screening ALT or AST above three times the upper limit of the normal range

•Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months)

•History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months

•Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, and poorly controlled symptomatic bradyarrhythmias or tachyarrhythmias

•Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack, or stroke within the last 3 months

•Coronary artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, and aortic; diagnostic catheters are allowed), or major surgery, including thoracic and cardiac surgery, within the last 3 months

•Inability to fully comprehend and/or perform study procedures in the investigator's opinion

•Vitamin B12 and/or serum folate deficiency according to the laboratory (re‐screening is possible after substitution therapy)

•Pregnancy or lactation

•Participation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study

ALT, alanine transaminase; AST, aspartate transaminase; CRP, C‐reactive protein; LVEF, left ventricular ejection fraction; TSAT, transferrin saturation.