Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised Double-blind Controlled Phase III Study to Compare the Efficacy and Safety of Intravenous Iron Carboxymaltose (Ferinject®) With Placebo in Patients With Chronic Heart Failure and Iron Deficiency
Brief Summary: This study is designed to evaluate the efficacy of Ferinject® in improving symptoms of CHF in patients with iron deficiency. Analyses will focus both on subjective and objective measures. Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.


Options:
A: Inclusion Criteria:

* Age \> 18 years
* Anemia (Hemoglobin \< 13.0 g/dL)
* ≤ 72 hours from hospital admission
* Current tolerance of enteral medications
* Expected ICU LOS \> 5 days

Exclusion Criteria:

* Active bleeding
* Chronic inflammatory disease
* End-stage renal disease
* Hematologic disorders
* Macrocytic anemia
* Current use of erythropoietin
* Pregnancy
* Prohibition of RBC transfusions
* Moribund state in which death is imminent
* Enrollment in another clinical trial
B: Inclusion Criteria:

* In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF)
* Left ventricular ejection fraction (LVEF) 40% or lower for patients in NYHA II and 45% or lower in NYHA III
* Screening haemoglobin (Hb) at least 9.5 g/dL but below or equal to 13.5 g/dL (average of 2 haemoglobin concentrations)
* Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20%

Exclusion Criteria:

* History of acquired iron overload.
* Known active infection, clinically significant bleeding, active malignancy.
* Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST)
* Anaemia due to reasons other than iron deficiency
* 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 ischaemic 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.
C: Inclusion Criteria:

* 18 years of age or older;
* Outpatients followed at a HF Clinic in a tertiary care Hospital with clinical diagnosis of HF for at least 3 months before study entry;
* NYHA functional class II to IV, who are able to perform ergospirometry;
* Documentation of LVEF \< 40% within the last 6 months;
* Adequate baseline therapy for HF based on patient's functional class (β-blockers, ACE inhibitors irrespective of functional class except if contra-indications, digoxin, spironolactone if NYHA class III or IV);
* Stable baseline HF therapy with same doses of medications and no intent to increase doses for the following 3 months;
* Hemoglobin ≤ 12 g/dl and \> 9 g/dl;
* Transferrin saturation \< 20% and ferritin \< 500 µg/L;
* Ability to provide written informed consent.

Exclusion Criteria:

* Any clinically overt bleeding: gastrointestinal bleeding, hypermenorrhea, history of peptic ulcer without evidence of healing or inflammatory intestinal diseases;
* Uncorrected hypothyroidism;
* Other inflammatory, neoplastic or infectious disease;
* Serum creatinine \> 1,5 mg/dl;
* Previous intolerance to oral elemental iron compounds;
* HF due to alcoholic cardiomyopathy, current regular drinker of alcoholic beverages or HF due to peripartum cardiomyopathy;
* Recent admission for decompensated HF (last month)
* Recent myocardial revascularization procedures (last 3 months);
* Recent ACS, stroke or TIA (last 3 months);
* Active or metastatic neoplastic disease with life expectancy of less than a year;
* Patients in heart transplantation list;
* Patients that had participated in any other clinical trial or study within the last month;
* Pregnant or lactating women;
* Pre-menopausal women that are not using any effective method of contraception;
* Patients using prohibited medications or that have not yet accomplished the wash-out period;
* Patients currently participating in cardiovascular rehabilitation programs.
D: Inclusion Criteria:

* Female subjects \>/= 18 years of age
* History of Heavy uterine bleeding
* Hgb \</= 11
* Practicing acceptable birth control
* Demonstrate ability to understand and comply with protocol

Exclusion Criteria:

* Known Hypersensitivity to oral or IV iron
* Anemia other than iron deficiency anemia
* Iron storage disorders
* Initiation of treatment that may effect degree of heavy uterine bleeding
* Anticipated need for surgery
* Severe psychiatric disorder
* Active infection
* Positive Pregnancy test
* Known Hep B or C or Active Hepatitis
* Received investigational Drug within 30 days
* Alcohol or drug abuse

Answer: B