Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised, Double-blind Controlled Phase 4 Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency
Brief Summary: The purpose of this study is to determine, relative to placebo, the effect of iron repletion therapy using intravenous (IV) ferric carboxymaltose on exercise capacity in patients with chronic heart failure and iron deficiency.


Options:
A: Inclusion Criteria:

* Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
* Reduced exercise capacity
* Reduced left ventricular ejection fraction
* At least 18 years of age and with written informed consent prior to any study specific procedures

Exclusion Criteria:

* Erythropoietin stimulating agent (ESA) use, IV iron therapy, and/or blood transfusion in previous 6 weeks prior to randomisation
* Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months
* Chronic liver disease and/or elevated liver enzymes
* Vitamin B12 and/or serum folate deficiency
* Subject is not using adequate contraceptive precautions during the study
* No other significant cardiac or general disorder that would compromise participation in the study
B: Inclusion Criteria:

* Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
* Reduced left ventricular ejection fraction
* Capable of completing 6 minute walk test
* At least 18 years of age and with written informed consent prior to any study specific procedures

Exclusion Criteria:

* Erythropoietin stimulating agent (ESA) use, IV iron therapy and/or blood transfusion in previous 6 weeks prior to randomisation
* Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months
* Chronic liver disease and/or elevated liver enzymes
* Vitamin B12 and/or serum folate deficiency
* Subject is not using adequate contraceptive precautions during the study
* Body weight ≤ 35 kg
* No other significant cardiac or general disorders that would compromise the ability to give informed consent and/or comply with study procedures
C: Inclusion Criteria:

* Signed informed consent prior to study specific procedures.
* Premenopausal, regularly menstruating women.
* Age ≥18 years.
* Body weight between 50 and 90 kg.
* Haemoglobin ≥115 g/L.
* Iron deficiency at screening defined as follows:
* S-ferritin level \<50 ng/mL, AND, TfS \<20%, OR,
* S-ferritin level \<15 ng/mL.
* Serum C-reactive protein:
* \<5 mg/L if not on oral contraception, OR,
* \<20 mg/L if use of oral contraception.
* Minimum total score of 5 on the Piper Fatigue Scale (PFS) (mean of items 2 to 23).
* Negative pregnancy test (serum human chorionic gonadotropin (hCG) at screening.
* Normal levels of vitamin B12 and folic acid at screening.
* Adequate contraception during the study period and for 1 month following study completion.
* Availability and willingness to complete all study visits and procedures per protocol.

Exclusion Criteria:

* Haemoglobin level \<115 g/L.
* Haemoglobinopathy.
* Haemochromatose.
* Major depressive disorder based on Patient Health Questionnaire (PHQ-9) (5 items with scores ≥2; one of which corresponds to question number 1 or 2).
* Any active or unstable concurrent medical condition (e.g., cancer, renal dysfunction, liver dysfunction (aspartate aminotransferase (AST); alanine aminotransferase (ALT) \>3-fold upper limit), angina (Class IV).
* Known human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B virus or hepatitis C virus infection.
* Chronic inflammatory disease (e.g., rheumatoid arthritis; inflammatory bowel disease).
* Documented history of clinically significant level of sleep apnoea defined as 5 or more episodes per hour of any type of apnoea.
* Intake of concurrent medications that could interfere with physical or mental performance (e.g., antidepressive, antihistamines, narcotic or any chemotherapeutic agents known to cause drowsiness).
* Important recent weight loss (\>10% within the past month).
* Body weight \<50 kg or \>90 kg.
* Thyroid dysfunction, thyroid stimulating hormone \>4 μU/mL.
* Intake of iron preparations 4 weeks prior to screening.
* Use of gestagens e.g., Implanon, Mirena, Depo-Provera for menstruation repression (see Section 7.7, Prohibited Therapy or Concomitant Treatment, page 35).
* Known hypersensitivity to FCM or to any other iron preparation.
* Pregnancy (positive hCG test at screening) or breast feeding.
* Participation in any other interventional trial within 4 weeks prior to screening.
* Inability to fully comprehend and/or perform study procedures or provide written consent in the Investigator's opinion.
* Subject is not using adequate contraceptive precautions during the study and for up to 1 month after the last dose of the study medication. A highly effective method of birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner.
* Subject previously has entered this study.
* Subject will not be available for follow-up assessments.
D: Inclusion criteria:

* Patients undergoing valve- and/or coronary bypass surgery
* Signed patient informed consent
* Only patients will be enrolled who won't have an emergency surgery on the same day

Exclusion criteria:

* Participation in another clinical trial within the last 4 weeks prior to enrollment
* Addiction or other disease that did not allow the patient to assess the nature, scope and possible consequences of the clinical tial
* Patients who do not sign the consent form or may not fully understand from inadequate knowledge of German.
* Patients who have not reached the age of legal majority
* Pregnant or lactating women
* Jehovah's Witnesses
* Patients with endocarditis
* Existing allergy or intolerance to ferric carboxymaltose or mannitol

Answer: B