Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study

Inclusion Criteria:

• 18 years of age or older;

• Outpatients followed at a HF Clinic in a tertiary care Hospital with clinicaldiagnosis 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, ACEinhibitors 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 increasedoses 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 ofpeptic 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 orHF 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 lastmonth;

• 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-outperiod;

• Patients currently participating in cardiovascular rehabilitation programs.