Heart Failure
Conditions
Brief summary
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
Interventions
DRUGFerric Carboxymaltose
Ferric carboxymaltose will be administered according to product specification dosing
DRUGPlacebo
IV nacl 0.9%
Sponsors
Ziekenhuis Oost-Limburg
Hasselt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Chronic heart failure and implantation of cardiac resynchronization therapy more than 6 months ago and presence of iron deficiency (ferritin \< 100 μg/l, irrespective of TSAT or ferritine between 100 - 300 μg/l with TSAT \< 20%) and presence of incomplete reverse remodeling (LVEF \< 40%). 2. Age ≥18 years 3. Obtained informed consent 4. Stable pharmacological therapy of heart failure during the last 4 weeks (with the exception of diuretics)
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. 15. Planned cardiac hospitalization during study follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in left ventricular ejection fraction from baseline | 3 months | delta\_LVEF measured by 3D-echocardiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart failure hospitalization and all-cause mortality | Up to six months | measured by telephone contact |
| Change in left ventricular end systolic volume from baseline | 3 months | delta\_LVESV measured by 3D-echocardiography |
| Force frequency relationship | 3 months | measured by 2D-echocardiography |
| Incidence of Treatment-associated Serious and non-serious adverse events. | During intravenous study drug administration and 1-hour in hospital follow-up | Serious and non-serious adverse events (AE) will be registered, which include:start date AE, duration AE, end-date AE, treatment group, continuation of AE after dose interruption, causality with study medication, presence of risk factors for AE and response to AE (sequela or recovery). |
| Change in left ventricular end diastolic volume from baseline | 3 months | delta\_LVEDV measured by 3D-echocardiography |
Other
| Measure | Time frame | Description |
|---|---|---|
| Predefined right ventricular (RV) analysis | 3 months | Assessment of effect of FCM on RV-function at rest and during incremental pacing. Assessment of RV-to-pulmonary artery coupling |
Countries
Belgium
Outcome results
None listed