Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney Disease

Inclusion Criteria:

• persistent severe CHF: functional class NYHA III (marked limitation of physical activity - comfortable at rest, but less than ordinary activity results in shortness of breath and/or fatigue16); left ventricular ejection fraction (echocardiography) less than 40%; functional and systolic dysfunction criteria must be stable at two different examinations one month apart;
• stable stage 3 chronic kidney disease: estimated GFR between 30-59mL/min/1.73m2 (mean value of three measurements within the last 8 weeks, separated from each other by at least one week); stable renal function (at least three different measurements within the past 8 weeks, separated from each other by at least one week; the difference between the highest and the lowest value should be less than 5mL/min/1.73m2)
• mild to moderate anemia: hemoglobin levels < 12g/dL (mean value of three measurements within the last 8 weeks, separated from each other by at least one week) and stable (at least three measurements within the last 8 weeks; the difference between the highest and the lowest value should be less than 1.5g/dL);
• iron deficiency: absolute (serum ferritin < 100ng/mL) or functional (serum ferritin 100-300ng/mL and transferrin saturation < 20%)

Exclusion Criteria:

• evidence of active gastrointestinal or genital tract bleeding
• folate or vitamin B12 deficiency
• hypothyroidism
• hemolytic anemia
• any primary kidney diseases (glomerulonephritis, interstitial nephritis, cystic diseases)
• systemic diseases with renal involvement (lupus erythematosus, vasculitis, amyloidosis)
• renal artery stenosis (>70% lumen reduction)
• diabetic nephropathy
• severe malnutrition (SGA score C or lower)
• active liver diseases
• infectious conditions
• malignancies
• C-reactive protein > 12 mg/L
• severe anemia (< 8.5g/dL)
• blood transfusions in the preceding two months
• iron therapy in the preceding three months
• concomitant erythropoietin therapy
• severe arterial hypertension (systolic BP >190 mm Hg and/or diastolic BP >115 mm Hg)
• recent history (less than 3 months) of acute coronary syndrome
• recent (less than 1 month) PCI
• recent (less than 1 month) CABG surgery
• active myocarditis
• active endocarditis
• more than mild valvar stenosis
• more than moderate valvar (mitral or aortic) regurgitation
• uncontrolled haemodynamically relevant atrial fibrillation/flutter
• hypertrophic cardiomyopathy
• acute and/or chronic pericarditis
• cor pulmonale
• participation in another study