Parenteral iron supplementation, chemoreflex response, quality of life and exercise capacity in patients with chronic heart failure

INTERVENTION: Trade Name: FERINJECT*INF 5FL 2ML 50MG/ML Pharmaceutical Form: Solution for injection Other descriptive name: FERINJECT Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 500‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use CONDITION: Chronic heart failure ; MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 ‐ Cardiac disorders Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: Test the hypothesis that parenteral iron therapy in patients with chronic heart failure and iron deficiency anemia absolute or functional chemoriflessa can improve the sensitivity and the patient's overall clinical condition Primary end point(s): Evaluation of complete blood count and parameters of iron metabolism Secondary Objective: ‐ Assess possible relationships between changes in the parameters of iron metabolism and clinical and functional responses to intravenous iron therapy. ‐ Identify between the different indices of iron metabolism analyzed what could best predict positive response to parenteral iron supplementation and better characterize the behavior of the indices of iron Timepoint(s) of evaluation of this end point: 3 weeks SECONDARY OUTCOME: Secondary end point(s): n.a. Timepoint(s) of evaluation of this end point: n.a. INCLUSION CRITERIA: ‐ Chronic heart failure ‐ Left ventricular ejection fraction <= 45% ‐ Iron‐deficiency anemia Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 66 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range