Clinical trial: Oral Iron Repletion Effects On Oxygen Uptake in Heart Failure (NCT02188784)

Eligibility criteria:
Inclusion Criteria:

          1. Age >18 years

          2. Previous clinical diagnosis of heart failure with current New York Heart Association
             (NYHA) Class II-IV symptoms LVEF≤0.40 within 2 years prior to consent, and ≥3 months
             after a major change in cardiac status (i.e. CABG or CRT).

          3. Serum ferritin between 15-100 ng/ml or serum ferritin between 100-299 ng/ml with
             transferrin saturation <20%

          4. Hemoglobin 9.0-13.5 g/dL (males), 9-13.5 (females) at time of enrollment

          5. Stable evidence-based medical therapy for HF (including beta-blocker and
             ACE-inhibitor/ARB unless previously deemed intolerant, and diuretics as necessary)
             with </= 100% change in dose for 30 days prior to randomization

             a. Changes in diuretic dose guided by a patient-directed flexible dosing program are
             considered stable medical therapy

          6. Willingness to provide informed consent

        Exclusion Criteria:

          1. Presence of a neuromuscular, orthopedic or other non-cardiac condition that prevents
             the patient from exercise testing on a bicycle/treadmill ergometer and/or inability to
             achieve an RER ≥ 1.0 on screening/baseline CPET

          2. Severe renal dysfunction (eGFR< 20 ml/min/1.73m2)

          3. Severe liver disease (ALT or AST > 3x normal, alkaline phosphatase or bilirubin >2x
             normal)

          4. Gastrointestinal conditions known to impair Fe absorption (i.e. inflammatory bowel
             disease)

          5. Known active infection as defined by current use of oral or intravenous antimicrobial
             agents

          6. Documented active gastrointestinal bleeding

          7. Active malignancy other than non-melanoma skin cancers

          8. Anemia with known cause other than Fe deficiency or chronic disease

          9. Fe overload disorders (i.e. hemochromatosis or hemosiderosis)

         10. History of erythropoietin, IV or oral Fe therapy, or blood transfusion in previous 3
             months.

         11. Current ventricular assist device

         12. Anticipated cardiac transplantation within the next 4 months

         13. Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis,
             constrictive pericarditis or tamponade

         14. Previous adverse reaction to study drug or other oral Fe preparation

         15. Known or anticipated pregnancy in the next 4 months
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


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