Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Trial to Assess the Effects of Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study
Brief Summary: Anemia has been demonstrated to be a common finding in patients with heart failure (HF). Previous studies in hospitalized patients with HF have found a prevalence of anemia ranging from 15% to 63%. More importantly, anemic patients with HF have increased morbidity and mortality. The mechanisms underlying anemia in HF are multifactorial, involving mild to moderate forms of anemia of chronic disease and ferropenic anemia. The clinical impact of iron supplementation in HF patients who have a relatively preserved renal function and either chronic disease anemia, ferropenic anemia or both remains largely unknown. The route of iron administration that could be most clinically effective is also unclear. Thus, the primary aim of the IRON-HF study is to assess the effects of iron supplementation alone (IV or PO) on parameters of functional capacity in HF patients with anemia with decreased availability of iron.


Options:
A: Inclusion Criteria:

* Patients 65 years and older.
* Osteoporotic hip fracture which require surgical intervention
* Haemoglobin levels between 90-120 g/L
* Signed informed consent form

Exclusion Criteria:

* Bone marrow diseases which could interfere in the erythropoietic process (acute or chronic myelodysplastic syndromes or myeloproliferative diseases, and/or infiltration of the bone marrow due to solid or lymphatic neoplasms)
* Blood coagulation diseases or currently treated with oral anticoagulants and/or heparin at therapeutic doses.
* Documented allergy and/or previous intolerance and/or contraindication of erythropoietin use and/or intravenous iron.
* Patients with rheumatoid arthritis and/or another demonstrated origin of inflammatory anemia and/or not controlled arterial hypertension.
B: 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.
C: 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
D: Inclusion Criteria:

* Men and women ≥ 18 years of age
* Patients subject to elective cardiac surgery under extracorporeal circulation
* Patients without previous anaemia, susceptible of treatment
* Patients without need of blood transfusion preoperative
* Patients providing written informed consent
* Patients who are able to complete all study visits per protocol

Exclusion Criteria:

* Patients subject to elective cardiac surgery, but without extracorporeal circulation
* Patients who were treated with fibrinolytic therapy 48 hours before the surgery
* Patients with history of impaired renal function, (e.g., calculated creatinine clearance \<50 mL/min/1.73 m2)
* Patients operated of active endocarditis
* Redo-surgery patients
* Women who are pregnant or lactating
* Patients with clinical of digestive bleeding
* Patients with vitamin B12 deficit
* Patients with ferropenic anaemia
* Patients with clinical history of asthma or allergy
* Patients with active infection
* Patients who are included in another clinical study
* Patients with hepatic disease
* Patients with history of allergy to iron
* Patients unlikely to adhere to protocol follow-up

Answer: B