Differential Gene Expression in Patients With Heart Failure and Iron Deficiency - Effects of Ferric Carboxymaltose
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01978028
Recruitment Status :
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with chronic heart failure of New York Heart Association Class II or III, a left ventricular ejection fraction of ≤ 40% for patients in NYHA class II or ≤ 45% for patients in NYHA class III, a hemoglobin level at the screening visit between 9.5-13.5 g/dl, and iron deficiency, which is defined as serum ferritin level < 100µg/l or between 100 and 299 µg/l, when transferring saturation is < 20%.
Age ≥18 years
Obtained informed consent
Stable pharmacological therapy during the last 4 weeks (with the exception of diuretics)
Hemochromatosis, iron overload, defined as TSAT > 45%
Known hypersensitivity to Ferinject®.
Known active infection, CRP>20 mg/L, clinically significant bleeding, active malignancy.
Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (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, poorly controlled symptomatic brady- or tachyarrhythmias.
Acute myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke within the last 3 months.
Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.
Participation in a CHF training program.
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.