EUCTR2006-004608-37-ITActive, not recruitingNot Applicable
A randomised double-blind controlled phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose (Ferinject) with placebo in patients with chronic heart failure and iron deficiency - FAIR-HF
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- VIFOR (INTERNATIONAL) INC.
- Enrollment
- 576
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patients who meet the following criteria at the start of treatment are eligible for the study: 1. At least 18 years of age and signed written informed consent. 2. In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF), and all of the following: a. Two weeks without cardiac hospitalisation. b. Patients in NYHA II must have had an unplanned hospital admission or emergency room visit for worsening of heart failure within one year prior to start of treatment. 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) 35% or lower as 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 start of treatment. For patients treated with beta-blockers or with cardiac resynchronisation, LVEF assessment for eligibility must be performed at least 12 weeks after stable beta-blocker therapy or device implantation. 4. Estimated glomerular filtration rate (e-GFR) below 60 mL/min/1.73 m2 as calculated using the Modification of Diet in Renal Disease trial (MDRD) formula. 5. Screening haemoglobin (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). 6. Screening ferritin below 100 μg/L, or below 300 μg/L when transferrin saturation (TSAT) is below 20%. 7. 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). 8. Adequate veins for repeated blood sampling and intravenous (i.v.) administration of investigational drug. 9. Negative pregnancy test and use of adequate contraceptive methods for women of childbearing potential. 10. 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: 0
- •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
- •Patients who, at the start of treatment, meet the following criteria are not eligible for the study: 1. History of acquired iron overload. 2. Known hypersensitivity to Ferinject. 3. Known active infection, CRP > 20 mg/L, clinically significant bleeding, active malignancy. 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.aemoglobinopathy). 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). 14. Pregnancy or lactation. 15. Participation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study.
Investigators
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