iron deficiency in patients with chronic heart failure MedDRA version: 8.1 Level: PT Classification code 10022970 Term: Iron deficiency
Conditions
Interventions
Product Name: Ferinject®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ferric Carboxymaltose (proposed INN)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
Vifor Pharma, Vifor (International) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At least 18 years of age and signed written informed consent. 2. In NYHA II-III functional class due to stable symptomatic CHF, and all of the following: a. Two weeks without cardiac hospitalisation. b. Patients in NYHA II must have had an acute care admission or emergency room visit for worsening of heart failure within 24 months prior to randomisation. c. On optimal conventional therapy (in general, optimal pharmacological treatment which includes a diuretic, a beta-blocker, and/or an angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) as determined by the investigator, unless contraindicated or not tolerated). d. No dose changes of heart failure drugs during the last 2 weeks (with the exception of diuretics). e. No introduction of a new heart failure drug class during the last 4 weeks. 3. Left ventricular ejection fraction (LVEF) 40% or lower for patients in NYHD II and 45% or lower in NYHD IIas assessed according to local methodology by 2-D echocardiography, radionuclide ventriculography, cardiac magnetic resonance imaging, or X-ray contrast ventriculography within 6 months prior to randomisation. For patients treated with beta-blockers or with cardiac resynchronisation, LVEF assessment for eligibility must be performed at least 3 months after stable beta-blocker therapy or device implantation. 4. Screening Hb at least 9.5 g/dL but below or equal to 13.5 g/dL (average of 2 haemoglobin concentrations as measured locally by HemoCue® analyzer; see Section 3.3.5.2). 5. Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20% (re-screening is possible after 4 weeks for patients with borderline higher ferritin concentrations or borderline TSAT percentage if the investigator feels that levels might drop below cut-off in the near future, see Section 3.8.1.1). 6. Resting blood pressures less than or equal to 160 mm Hg (systolic) and less than or equal to 100 mm Hg (diastolic at the disappearance of sounds, Korotkoff phase V). 7. Adequate veins for repeated blood sampling and i.v. administration of investigational drug. 8. Negative pregnancy test and use of adequate contraceptive methods for women of childbearing potential. 9. Patient must be able to perform the 6 minute walk test according to investigator judgement Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of acquired iron overload. 2. Known hypersensitivity to Ferinject®. 3. Known active infection, CRP > 20 mg/L, clinically significant bleeding, active malignancy (re-screening is possible after 4 weeks for patients with elevated CRP concentrations if the investigator feels that levels might normalize in the near future, see Section 3.8.1.1). 4. Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range. 5. Anaemia due to reasons other than iron deficiency (e.g. haemoglobinopathy). 6. Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months). 7. History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months. 8. Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias. 9. Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months. 10. Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months. 11. Known HIV/AIDS. 12. Inability to fully comprehend and/or perform study procedures in the investigator’s opinion. 13. Vitamin B12 and/or serum folate deficiency according to the central laboratory (re-screening is possible after substitution therapy, see Section 3.8.1.1). 14. Pregnancy or lactation. 15. Participation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine, relative to placebo, the effect of iron repletion therapy using intravenous ferric carboxymaltose (Ferinject®) on self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy in patients with chronic heart failure and iron deficiency.;Secondary Objective: Main secondary objective: To evaluate the effect of intravenous ferric carboxymaltose (Ferinject®) compared with placebo on Exercise tolerance (6-minute walk test distance). Other secondary objectives: To evaluate the effect of intravenous ferric carboxymaltose (Ferinject®) compared with placebo on health related quality of life and to evaluate resource use and costs associated with the treatment with intravenous ferric carboxymaltose (Ferinject®) compared with placebo. ;Primary end point(s): Self-reported patient global assessment (PGA) score and change in NYHA class from baseline to Week 24 visit after start of investigational drug, taking into account patients who are hospitalised at that time or have died. | — |
Countries
Belgium, Czech Republic, Germany, Italy, Spain, Sweden
Outcome results
None listed