Heart failure with reduced left ventricular ejection fraction MedDRA version: 20.0 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Injectafer
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: FERRIC CARBOXYMALTOSE
CAS Number: 9007-72-1
Current Sponsor code: not applicable
Other descriptive name: injectaf
Sponsors
Ziekenhuis Oost Limburg (ZOL), Genk
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with chronic heart failure and implantation of cardiac resynchronization therapy more than 6 months ago and presence of iron deficiency (ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: 1. Hemochromatosis, iron overload, defined as TSAT > 45% 2. Hemoglobin > 15 g/dl at inclusion 3. Known hypersensitivity to injectafer®. 4. Known active infection, CRP>20 mg/L, clinically significant bleeding, active malignancy. 5. Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range. 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 ischemic 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. Inability to fully comprehend and/or perform study procedures in the investigator's opinion. 12. Vitamin B12 and/or serum folate deficiency according to the laboratory (re-screening is possible after substitution therapy). 13. Pregnancy or lactation. 14. 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 assess impact on left ventricular reverse remodeling defined as a change in left ventricular ejection fraction in heart failure patients with reduced ejection fraction (and previous implantation of cardiac resynchronization therapy) undergoing treatment with ferric carboxymaltose vs. placebo;Secondary Objective: To assess left ventricular reverse remodeling also defined as left ventricular volumes and cardiac biomarkers;Primary end point(s): Change in left ventricular ejection fraction;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in left ventricular end-diastolic, end-systolic volume and cardiac biomarkers;Timepoint(s) of evaluation of this end point: 3 months | — |
Countries
Belgium
Contacts
Public ContactPieter Martens
Ziekenhuis Oost Limburg
Outcome results
None listed