This is a randomized double-blind explorative controlled clinical Trial that analyses the effects of 1000mg ferric carboxymaltose in patients with chronic heart failure and iron deficiency.
Conditions
Interventions
Trade Name: Ferinject
Product Name: Ferinject
Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion
INN or Proposed INN: FERRIC CARBOXYMALTOSE
CAS Number: 9007-72-1
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Sponsors
Medical University Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written, signed and dated informed consent. 2. Male and female patients over 18 years. 3. Women of childbearing potential must have a negative pregnancy test and must refrain from breastfeeding. Women who are postmenopausal (1 year since last menstrual cycle), surgically sterilized or who have undergone a hysterectomy are considered not to be of childbearing potential. 4. NYHA class of higher than or equal to NYHA class II 5. Left ventricular ejection fraction (LV-EF) less than or equal to 40% (HFrEF) as assessed by echocardiography, radionuclide ventriculography or contrast angiography within the last 30 days. 6. Iron deficiency (ID) defined as ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Cardiac surgery or coronary angioplasty within 30 days before study drug initiation. 2. Acute coronary syndrome within 30 days before study drug initiation. 3. Patients who are scheduled for cardiac surgery or angioplasty in the next 3 months. 4. Current implanted ventricular assist device (VAD) 5. Stroke or transient ischemic attack (TIA) within 3 months before study drug initiation. 6. Dialysis-dependent renal failure (eGFR < 20 mL/min/1.73m2) 7. Severe Iron deficiency defined as ferritin < 15 µg/L 8. Phosphate levels below the lower limit normal before study drug initiation (< 0.80 mmol/L). 9. Active infection as defined by current use of oral or intravenous antimicrobial agents. 10. Anaemia with known cause other than iron deficiency (ID) or chronic disease. 11. Malignancies 12. Body weight < 50 kg 13. Known allergy against intravenous iron preparation 14. Iron substitution, erythropoietin therapy or blood transfusion in the previous 6 months. 15. Changes in CHF therapy or lipid-lowering therapy within the last 30 days. 16. Participation in another interventional trial. 17. Pregnant woman and nursing mother.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of this study is to identify the mechanism(s) underlying the beneficial effects of iron supplementation in iron-deficient patients with CHF.;Secondary Objective: Secondary objective is to identify those patients who may benefit from iron supplementation as compared to those who will not. Another aim of this study is to evaluate the therapeutic efficacy based on the underlying cause of iron deficiency (absolute versus functional ID), inflammatory status and co-medications.;Primary end point(s): 1. Changes in blood count (including reticulocyte count and reticulocyte hemoglobin content), iron, Tf, TSAT, ferritin, sTfR, hepcidin-25, hsCRP, calprotectin, neopterin, IL-6, IL-10, TNF-??, FACS peripheral, NT-proBNP, troponin T, creatinine (GFR), ASAT, ALAT, AP, GGT, LDH, triglycerides, total cholesterol, LDL, HDL, electrolytes (Na, K, P, Ca), PTH, 1,25-(OH)2 vitamin D and 25-OH vitamin D, LCN2, EPO, ERFE, PDGF-BB, VEGF, FGF23, secretoneurin, TBARS, TOC, OxLDL and metabolites (ATP, NADH/NAD, Lactate, Succinate, Citrate, Pyruvate, free fatty acids), tryptophan, kynurenine, tyrosine and phenylalanine. 2. Changes in blood gases (pH, pCO2, pO2, SaO2, HCO3, BE) 3. Changes in mitochondrial iron and Krebs cycle metabolism gene expression in monocytes detected by RT-PCR. 4. Changes in mitochondrial respiration of selected and randomly assigned patients measured with OROBOS respirometry. 5. Changes in EndoPAT, DVA 6. Changes in pulmonary function detected by spirometry and diffusion measurement 7. Time to death, high-urgent transplantation, ventricular assist device (VAD) implantation or non-fatal HF event requiring i.v. vasoactive therapy (i.v. diuretics, i.v. vasodilators or i.v. inotropes – either in-hospital or ambulatory in an emergency department) or hospitalization for any reason 8. Changes in background medication ;Timepoint(s) of evaluation of this end point: end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Change in functional status # 6-minute walk test (6MWT) at baseline, day 2 and day 90 # New York Heart Association (NYHA) class at baseline, day 2 and day 90 # Change in LV-EF from baseline to day 90 2) Change in symptoms # Kansas City Cardiomyopathy Questionnaire (KCCQ) – clinical summary score – from baseline to day 2 and day 90 # European Quality of Life-5 Dimensions (EQ-5D) – clinical summary score – from baseline to day 2 and day 90 # Difference in Patients Global Assessment (PGA) from baseline to day 2 and day 90;Timepoint(s) of evaluation of this end point: end of the study | — |
Countries
Austria
Contacts
Public ContactDepartment of Internal Medicine II
Medical University Innsbruck
Outcome results
None listed