Beneficial effects of vitamin D combined with oral iron supplementation in patients with chronic heart failure and iron deficiency (VICTORID-HF TRIAL)

Laborértékek

• Myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke, coronary artery bypass, percutaneous intervention, or major thoracic or cardiac surgery within the previous 2 months; clinically relevant (severe) non-corrected valvular heart disease, obstructive cardiomyopathy; chronic anemia due to non-correctable causes other than iron deficiency and anemia of chronic disease (e.g., hemoglobinopathies, hematologic malignancies, hemolytic anemia); anemia due to vitamin B12 or acid folic deficiency (recruitment may be re-evaluated at least 6 weeks after the end of vitamin B12 and or folic acid supplementation); history of acquired iron overload; administration of erythropoietin, iron supplementation (either oral or intravenous iron), blood transfusion in the previous 6 weeks or already scheduled for 3 months after recruitment; administration of vitamin D or similar in the 3 months preceding or already scheduled for the 3 months following recruitment; severe bone disease; active infections (C-reactive protein >20 mg/L); clinically significant bleeding; active neoplasm (with exception of basal cell or squamous cell carcinoma of the skin and intraepithelial cervical neoplasia); chronic liver disease (including active hepatitis) and/or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x normal limit; immunosuppressive therapy or dialysis; pregnancy or breastfeeding; the subject has a known sensitivity to any of the products that will be administered during the study protocol.

• Stable symptomatic chronic heart failure (NYHA functional class II-III) and all of the following: at least 3 weeks since the last hospitalization or emergency department access for acute HF, optimal drug treatment for heart failure (HF) according to the ESC guidelines determined by the investigator (unless contraindications or treatment not tolerated), no changes in HF therapy dose in the previous 2 weeks (except diuretics), no new HF therapy in the 3 weeks prior to recruitment, left ventricle ejection fraction <=45% , brain natriuretic peptide >100 pg/mL and/or N-terminal-pro-brain natriuretic peptide >400 pg/mL at pre-recruitment evaluation, evidence of iron deficiency defined as ferritin <100 ng/ml or TSAT <20% in the case of ferritin levels between 100 and 300 ng/ml, vitamin D levels <50 nmol/L, the subject must be able to complete the 6-Minute-Walking -Test, at least 18 years of age.