Clinical trial: Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency (NCT03218384)

Eligibility criteria:
Inclusion Criteria:

          -  Symptomatic NYHA Class II-III heart failure >3 months

          -  Guideline-recommended heart failure treatment for > 3 months

          -  Hemoglobin >13 g/dl for men and >12 g/dl for women

          -  Functional iron deficiency (defined as serum ferritin level <100 ng/ml or between 100
             and 299 ng/ml with transferrin saturation <20%)

          -  Left ventricular ejection fraction <40%, or left ventricular ejection fraction ≥40%
             with left atrial enlargement (left atrial volume index >28 ml/m2) and/or left
             ventricular hypertrophy (left ventricular mass index >95 g/m2 (women) or >115 g/m2
             (men) determined by echocardiogram within last 24 months.

          -  Able and willing to provide written informed consent

        Exclusion Criteria:

          -  Presence of implantable defibrillator, permanent pacemaker, other metal implant not
             compatible with 3TMRS/MRI, or other contraindication to 3T MRS/MRI procedures

          -  Heart failure due to infiltrative cardiomyopathy, restrictive cardiomyopathy, or
             hypertrophic cardiomyopathy

          -  Weight <50 kg or >120 kg

          -  Coronary or cerebral atherothrombotic events in the past 6 months

          -  Hospitalization of emergency room visit for heart failure within past 3 months

          -  ICD shock in last 3 months

          -  Known peripheral artery disease or ankle-brachial index <0.9 at screening visit

          -  Exercise primarily limited by angina, lung disease or neuromuscular disease

          -  Systolic blood pressure <100 or >160 mmHg

          -  Heart rate <50 or >110 min-1

          -  Estimated glomerular filtration rate <30 ml/min

          -  Liver function tests >3 times upper limit of normal

          -  Serum phosphate below normal limit

          -  Pregnant or breast-feeding women

          -  Women of child-bearing potential unwilling to use recommended contraception methods
             during the study

          -  Treatment with oral iron supplements (except multivitamins) in past year

          -  Treatment with intravenous iron in past year

          -  Treatment with erythropoiesis stimulating agents in the past year

          -  Known intolerance of intravenous iron

          -  History of anaphylaxis

          -  Participation in another clinical trial within last 30 days.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug.  Blood pressure is 120/80 mm Hg and pulse is 70/min.  Oxygen saturation is 99% on room air.  BMI is 24 kg/m2.  Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis.

Patient description (patient's own words): I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550  μg/L. The doctor diagnosed me with iron overload.

Does the patient match the trial criteria? Contradiction