Chronic Heart Failure MedDRA version: 19.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Ferinject 50 mg / ml solution for injection and infusion
Pharmaceutical Form: Solution for injection/infusion
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of a
Sponsors
Instituto de Investigación Sanitaria INCLIVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with ambulatory chronic HF 2. Older than 18 years. 3. Patients in NYHA class II-III on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of HF drugs during the last 2 weeks (with the exception of diuretics). 4. Elevated natriuretic peptides levels (NT-proBNP >400 pg/ml) at the screening visit 5. LVEF =65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: The participant may not enter the study if ANY of the following conditions is present: 1. Known sensitivity to any of the products to be administered per protocol. 2. History of acquired iron overload. 3 Severe valve disease, or being scheduled for cardiac surgery within the next 30 days 4 Acute myocardial infarction or acute coronary syndrome, transient ischemic attack, or stroke within the last 3 months prior to randomization. 5. Coronary artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, and aortic; diagnostic catheters are llowed), or major surgery, including thoracic and cardiac surgery, within the last 3 months prior to randomization. 6. Ischemic heart disease scheduled for revascularization procedures within the next 30 days. 7. HF scheduled for cardiac resynchronization therapy within the next 30 days. 8. Patients with active bleeding in the last 30 days. 9. Known active infection or active malignancy. 10. Subject at an immediate need of transfusion or hemoglobin =15 g/dL. 11. Anemia due to reasons other than iron deficiency 12. Immunosuppressive therapy or renal dialysis 13. History of erythropoietin, intravenous iron therapy, and blood transfusion in the previous 12 weeks. 14. Oral iron therapy at doses >100 mg/day in previous 1 week prior to randomization. 15. Subjects with an immediate need for transfusion. 16. Pregnant or breastfeeding women. 17. Subject of childbearing potential who is not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication. 18. Subject currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study, or subject is receiving other investigational agent(s). 19. Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine and quantify the changes in myocardial iron content at 7 and 30-day after the administration of intravenous ferric carboxymaltose. Such changes will be assessed by T2* CMR.;Primary end point(s): Changes in myocardial iron content assessed by T2* CMR on day 7 and day 30 after drug administration.;Timepoint(s) of evaluation of this end point: 7 and 30 days;Secondary Objective: - To correlate the changes in myocardial iron content after the administration of intravenous ferric carboxymaltose with the evolution of surrogate markers of disease’s severity at 7 and 30 days. - Left ventricular ejection fraction -. Functional capacity -Quality of life indicators -Biomarkers - The same correlates as point 1, but stratified in subgroups: - Age >70 vs. =70 years -Anemic vs. non-anemic -Ischemic vs. non-ischemic etiology. - To correlate myocardial iron content and its changes with blood markers related to iron biology/deficiency at 7 and 30 days. - Transferrin saturation index (TSAT) - Ferritin - Soluble transferrin receptor (sTfR) - Hepcidin | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 7 and 30 days;Secondary end point(s): Effect of T2* CMR changes on day 7 and day 30 after after drug administration on: 1. Changes in left ventricular systolic function evaluated with CMR 2. Changes in functional capacity assessed by distance walked in 6 minutes (6MWT), and New York Heart Association (NYHA) class 3. Quality of life assessed by The Kansas City quality of life questionnaire (KCCQ) 4. Biomarkers: Antigen carbohydrate 125 (CA125), amino-terminal pro-brain natriuretic peptide (NT-proBNP), galectin-3, ST-2, high-sensitivity troponin (hsTnT), cystatin C, neutrophil gelatinase-associated lipocalin (NGAL), serum creatinine, urea, estimated glomerular filtration rate (eGFR), hemoglobin, ferritin, TSAT, sTfR and hepcidin. | — |
Countries
Spain
Contacts
Public ContactMarta Peiro
Instituto de Investigación Sanitaria INCLIVA
Outcome results
None listed